Communication and questions were the theme on November 28 at FDA's Public Workshop on Troponin Assays — all about the opportunities and quandaries associated with high sensitivity and not so high negative predictive value. Consistent with this, slide decks were short and most of the time was spent in five different panel discussions. Below is a list of topics covered and a few notable points from each. Also, here's a link an FDA page with recorded proceedings listed in sections – Part 1 through Part 4 – under Webcast Archive and Slides.
We'll be watching for next statements and next steps from FDA, and we're ready to work with clients who have pending matters in each of these areas.
Beaufort, a leading diagnostic CRO and Regulatory consultancy, is experienced in assisting clients with Troponin assay goals. We work with both clients and sponsors in developing assays and managing every stage of your clinical trial. Contact us to learn more about how we can support your Troponin and other clinical, regulatory, quality and staffing needs.
Lucy Gibney, MD, is Medical Director at Beaufort where she provides clients with a breadth of experience in medical, scientific and clinical leadership. Lucy advises operations staff in all aspects of medical management of clinical trials, while serving as a medical expert during the project delivery lifecycle.
As the FDA is applying increasing pressure on sponsors to validate the work of their CROs, the need for independent quality oversight has become a critical element of the clinical trial process. Beaufort is the first CRO to offer independent quality oversight services to help sponsors ensure CRO's are performing according to expectations and commitments as mandated by the FDA and other regulatory bodies.
Beaufort's comprehensive approach to quality oversight is based on developing a QO plan that helps maximize CRO performance and identifies opportunities for early process improvement to help prevent delays and save cost.
Read this Case Study to see how Beaufort helped a global pharmaceutical firm that needed in-process oversight of its CROs for a pivotal Phase III trial.
During the Diagnostics Update session by Khatereh Calleja, JD, senior vice president of Technology & Regulatory Affairs at AdvaMed, it was confirmed that the controversial leftover specimens rule change was removed from the Common Rule (The Federal Policy for the Protection of Human Subjects). Originally published in 1991, the Common Rule safeguards individuals who participate in research. In September 2015, HHS and the other Common Rule agencies published a Notice of Proposed Rulemaking (NPRM), including a provision that would have required researchers to obtain consent before using a study participant's non-identified biospecimens.
Inspired by the case of Henrietta Lacks, a poor black woman whose cancer cells became widely used in research labs without her or her family's consent, the proposed change would have required written consent for broad future use of such deidentified samples. At great cost, institutions would have had to set up systems to track the consent data, which likely would have prevented many small hospitals and clinics from providing samples for research. This was definitely a win for the research community.
FDA's Bioresearch Monitoring (BIMO) investigators are seeing an increase in studies using leftover samples that are conducted without documented Institutional Review Board (IRB) approval. IRB approval is required when a sponsor performs a study in support of a pre-market approval application that will be submitted to FDA. Beaufort clients can rest assured that their studies receive appropriate IRB approvals and other required documentation.
OIR Director Alberto Gutierrez, Ph.D., gave an update on the agency's work on developing a new oversight policy for Laboratory Developed Tests (LDTs). He explained in December that FDA will wait until the new White House administration is in place before updating the LDT framework and will continue enforcement discretion.
FDA was asked by Congress not to publish final guidance or a white paper. The agency issued a discussion paper in January, but is not likely to publish anything further. Gutierrez commented that Congress stepping in will be the easiest way to resolve the issue and that he does not believe that FDA will be the determining factor.
director of the Division of Chemistry and Toxicology Devices at FDA, made an interesting comment regarding pre-submissions: they are meant to be a one-round thing. Some companies submit a lot of unnecessary pre-submissions. If you are not sure if you need a pre-submission, contact FDA first to inquire, or look to the recently cleared 510(k) summaries for good case studies about what's needed. Director Gutierrez reiterated that OIR is always willing to interact.
The message here remains the same: talk to FDA. The new emphasis is on being cognizant of when a pre-submission is needed and when it's not. And, use case studies as guides so the process is efficient. If you need a pre-sub, try sticking to just one. At Beaufort, this is something we regularly help our clients with. If you need help determining when to submit and when to hold back, we can guide you through the process.
There were two sessions on the new In Vitro Diagnostic Regulations (IVDR) in the European Union, which will take effect by the end of June. The first session described the increased regulations—and workload—for manufactures; the second session described the extra work for Notified Bodies (NBs).
The main takeaway was that under the current In Vitro Diagnostic Directive (IVDD) 80 percent of IVDs do not have their technical documentation reviewed by an NB. Under the new IVDR, the opposite will be true: 80 percent of IVDs will require technical documentation review by an NB. Carol Ryerson, principal advisor at RCRI, recommended that manufacturers read the entire IVDR and that they write their reports as if the NB did not have access to any other documents.
Beaufort experts can help guide you through these changes to ensure that your technical documentation meets all the requirements on the NB's checklist.
Global contract research organization bolsters its commitment to delivering the highest quality services to the life sciences industry.
NORFOLK, Va., Feb. 13, 2017—Beaufort, a contract research organization (CRO), has obtained ISO 9001:2015 certification. The certification demonstrates that Beaufort provides consistently good quality services to the life sciences industry in its clinical research, regulatory affairs, quality, and staffing solutions.
ISO (International Organization for Standardization) is an independent, non-governmental worldwide federation that develops international standards. ISO 9001:2015, the latest edition of ISO's flagship quality management systems standard, is a worldwide quality standard that helps organizations demonstrate that they offer products and services of consistently good quality.
"We believe a well-structured quality system is critical to the success of our clients' work. This ISO certification provides third party validation of our commitment to a quality-first approach and helps further set Beaufort apart from other CROs," explained John R. Wilson Jr., PhD, MPH, Beaufort senior vice president of clinical development and quality solutions.
To obtain ISO 9001:2015 certification, a firm must demonstrate that it: practices evidence-based decision making; addresses risks and opportunities in a methodical manner; and ensures that quality policy and quality objectives are established for the quality management system that are compatible with the context and strategic direction of the organization.
Beaufort, LLC, is a contract research organization that provides in vitro diagnostic, medical device and biopharmaceutical clinical and regulatory services, and a full range of quality solutions and staffing solutions. For more than a decade, companies worldwide have trusted Beaufort for its client-oriented approach to research. With operations spanning the globe, Beaufort has a proven track record working closely with clients and regulatory agencies internationally to bring complex and therapeutic-specific products to market. Learn more at BeaufortCRO.com.
The fall FDA‐Industry IVD Roundtable Meeting hosted by the Office of In Vitro Diagnostics and Radiological Health (OIR) of the FDA's Center for Devices and Radiological Health took place in Silver Spring, MD on December 2nd. Here are a few of the day's highlights.
Gutierrez explained that FDA still believes that regulating LDTs is important, but it will wait until the new White House administration is in place before updating the LDT framework.
Also of note, OIR has introduced payer participation in pre-submissions. Even if sponsors aren't eligible or don't want to participate in the Parallel Review Program with CMS, they can still request CMS or private payer feedback in their pre-submission meetings if it is requested first.
Reena Philip, Ph.D., director of the Division of Molecular Genetics and Pathology, reviewed the first "liquid biopsy test" to be approved for non-small cell lung cancers (NSCLCs): the cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.). The Roche test was one of three to date to be granted EAP status. It is a true unmet need because Stage III/IV lung cancer patients are too sick to give a biopsy.
Roche Director of Regulatory Affairs Lesley Farrington recalled that they had been at FDA 10 times over 18 months during the submission process, and commented that it costs less to talk to FDA frequently than to repeat studies. This is why Beaufort pushes clients to do pre-submissions—FDA collaboration is vital to success!
Leanne Kiviharju, with the AdvaMed POC Diagnostics Subteam, presented some interesting points to consider regarding Point of Care (POC) Diagnostics.
How does FDA educate reviewers and other groups that POC and CLIA waived tests are not the same?
Why does FDA identify differences in POC tests compared to mainframe tests that are also moderate complexity?
When a POC predicate is traceable to a standard, such as NIST, what is the scientific reason for requesting a method comparison of the new POC device with a clinical laboratory device in addition to the traceable POC device?
At the conclusion of the presentation OIR Director Gutierrez remarked that POC means near patient testing, and that the questions posed during the presentation were too narrow to be answered in a general sense and can be answered only in reference to specific projects.
The IVD Roundtable agenda and presentations can be found here.
We're just back from AMDM's 2016 IVD Focus Meeting. This annual event is always exciting as it brings together industry experts and thought leaders to exchange ideas, examine trends, and explore best practices. I was honored to share the stage with many peers and industry professionals over the 2-day conference and provide my perspective on the regulatory landscape during my Industry Update on day one.
Effective regulatory strategies will take on a new twist when In Vitro Diagnostic Regulations (IVDR) in the European Union are formally published later this year.
The FDA Pacific Region Compliance Update warned that enforcement trends continue to be rigorous and firms should pay heed to having compliant QM systems. At Beaufort, we see quality management as improving quality across all GxP processes, from personnel education to data integrity.
The FDA announced the publication of the draft guidance document "Principles for Co-Development of an In Vitro Companion Diagnostic (CDx) Device with a Therapeutic Product." This is a how-to guide that certainly will affect a sponsor's approach to the CDx paradigm.
FDA also described the guidance document "Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices," which went into effect September 19 and provides new opportunities to sponsors wishing to address the pediatric population.
Beaufort is an industry leader in developing comprehensive regulatory solutions that address the unique needs of clients and products. We have the technical and operational experience to navigate the landscape of challenges and changes and create and manage strategies that result in success for our clients.
In view of ExL's upcoming 7th Clinical Quality Oversight Forum in Philadelphia, Beaufort quality oversight thought-leader John Wilson offers insight into some of the industry's hot topics.
How will the revisions to the ICH E6 GCP Guidelines affect clinical quality oversight?
The additional language in Revision 2 can only mean that sponsors now will need to demonstrate oversight above and beyond standard QA and QC practices. Regulatory authorities will be looking for a documented, unbiased and objective assessment of the vendor CRO work effort.
Independent quality oversight is a cornerstone for Beaufort. We provide our quality oversight clients with solid documentation including a quality oversight plan listing the key processes for assessment along with methods and timelines. We also provide two reports of hard metrics. An internal report, compiled on a regular basis that contains a comprehensive, quantifiable analysis of high risk issues, is used to drive early process improvement, CAPA and provide management with real-time metrics. A second report is used during FDA inspections to demonstrate exactly what the sponsor, through third-party quality oversight, did to ensure that the CRO provided its services according to contractual and regulatory requirements.
What is the difference between clinical QA and quality oversight?
Quality oversight differs considerably from QA and should not duplicate standard QA practices. Quality oversight is about processes and adherence to contractual and regulatory requirements. It is not about co-monitoring or re-auditing the study.
Clinical QA assures the integrity of the clinical data. Quality oversight provides an assessment of how a CRO is performing relative to requirements, standards, and expectations.
Clinical QA is conducted as an assessment at one point in time. Quality oversight is performed over the course of the trial and allows for real-time early process improvement and CAPA.
Clinical QA is provided by the sponsor as a function within the organization. Quality oversight involves an independent organization, thus providing a totally objective assessment of the CRO work effort.
Third-party quality oversight provides an independent assessment of CRO and other vendor performance, resulting in opportunities for early process improvement and resultant cost and time savings.
How does vendor oversight change between the strategic partner, preferred provider and functional service provider models? What remains the same?
It is important to take into account which service provider model a sponsor is using in order to prescribe the best approach to vendor oversight.
In a strategic partner or preferred provider model, where a long-term relationship exists between a sponsor and its clinical trial CRO, a "familiarity bias" may exist that makes it difficult for the sponsor to adequately assess the vendor CRO's performance. In these models vendor oversight is best executed by a third party.
In a functional service provider arrangement, while it is much less likely that familiarity would interfere with objectivity, there remains the new requirement to provide and document active vendor oversight. In this, all three models remain the same.
Risk-based monitoring has become increasingly complex. Will it continue to grow in complexity or will the pendulum eventually swing back to a simpler approach?
The answer is a bit of both. It is important to understand that the requirement is for a risk-based approach, not necessarily a complex algorithm of percentages of certain data points to monitor, for example. After performing a risk analysis, some sponsors still will choose 100% source data verification. This isn't the same as choosing not to do a risk-based approach. Rather, their risk-based approach led them to conclude that 100% SDV was appropriate for a given trial. Others, after going through the steps of a risk analysis, determine that a more structured, less-than-100% SDV approach is optimal for a given trial.
So it is not a matter of whether the pendulum swings toward more or less SDV. What is important is that all sponsors engage in a risk-based approach in this decision making.
How can sponsors and CROs be prepared for change–whether it be in regulations, staff turnover, M&As, or other changes both anticipated and unanticipated?
My best advice: Know the regulations inside and out. Also, trust your people and the process. We have found the most successful clients are those who are systems dependent and work within a framework that ensures efficient and effective processes.
It is also critical to demonstrate active oversight. Having an effective QO program in place is important, but equally important is working with a CRO like Beaufort that has a comprehensive understanding of the regulatory environment, that is supported by a highly qualified team, and that has a proven track record of successfully managing clinical trials. Bringing skilled people to the table ensures more accountability, more flexibility and more continuity even in the midst of a changing landscape.
John R. Wilson Jr., PhD, MPH, is senior vice president, Clinical Development and Quality Solutions, at Beaufort where he is responsible for Beaufort's quality oversight and clinical trial monitoring practices. John has worked in the health care industry his entire career and has broad-based experience in clinical research and pharmaceutical manufacturing, regulatory strategy and compliance, and quality management.
We've just returned from RAPS' 2016 Regulatory Convergence conference in San Jose, Calif. This year marks the 40th anniversary of RAPS' formation to help establish the regulatory profession as a critical and distinct discipline. Today RAPS is known for bringing together regulatory industry experts and thought leaders to exchange ideas, examine trends, and explore best practices. This year's Convergence was no exception.
New UDI Requirements: Are You Ready?
The labels and packages of class II medical devices must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Class II stand-alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
During a RAPS workshop we learned that an industry survey has shown that the most difficult part of UDI compliance is the re-design of the labeling/packaging and updating the labeling system. The survey also showed that as of March 2016 only 62% of manufacturers were ready for FDA inspection of their UDI system.
This is precisely the kind of thought leadership that Beaufort can offer medical device manufacturers. We have the technical and operational experience to navigate the landscape of medical device regulatory changes and challenges including implementation of the new UDI requirements.
In our opinion, the most important topic discussed for IVD manufacturers was the state of using leftover human specimens in IVD device studies.
Upcoming changes to the Common Rule for the Protection of Human Subjects could have a big impact. Under the new proposed rule, informed consent (IC) rules would become significantly tighter where IC would need to be sought for using leftover specimens for future clinical research.
Further, the new In Vitro Diagnostic Regulations (IVDR) in the European Union, set to be published in late 2016 or early 2017, also will propose big changes to informed consent. Under the proposed regulations, if patients withdraw their consent, not only will manufacturers need to discard the sample, but they also will need to remove that patient's data from all data sets, publications and submissions.
These new rules will put bigger burdens on IVD manufacturers, making prospective studies more of the norm, even for Class II IVD studies. Now more than ever medical device manufacturers should seek guidance from third party resources to help alleviate this burden. At Beaufort we do this by developing regulatory strategies that address both industry-wide changes and the unique needs of our clients.
It was amusing when one of the workshop speakers equated regulatory affairs professionals to "traffic cops"—but they were right. An RA professional can assist with preclinical planning and design by having proactive interactions with regulatory agencies and prompt consultations with you throughout the entire IVD development process. To gain maximum value from the data that can strengthen your submission and even reduce timelines and budget, bring in Regulatory Affairs into the process early and often.
The Association of Medical Diagnostics Manufacturers (AMDM) will hold its 2016 IVD Focus Meeting October 13 and 14 in Los Gatos, Calif. Beaufort's Robert Di Tullio, Sr., VP, Global Regulatory Services, will present an industry update on October 13 from 9:00 to 9:30 a.m. Beaufort also will sponsor the 10:30 a.m. event break that same day and will exhibit throughout the meeting. Beaufort has proudly participated in AMDM meetings for more than five years.
Robert is an accomplished regulatory affairs professional with 42 years' experience in the in vitro diagnostics industry with the last 29 years in regulatory, clinical and quality management. Prior to joining Beaufort, he was Vice President of Global Regulatory and Clinical Affairs for Alere and held similar positions at ProteoGenix, Sequenom, Siemens Medical Solutions Diagnostics and Diagnostic Products Corporation.
Robert's April 2015 presentation, "The Changing Regulatory and Policy Environment for Diagnostics: What to Expect in 2015 & Beyond," given at the AMDM 2015 Annual Meeting can be viewed here.
Beaufort, LLC, is a contract research organization that provides in vitro diagnostic, medical device and biopharmaceutical clinical and regulatory services, and a full range of quality solutions and staffing solutions. For more than a decade, companies worldwide have trusted Beaufort for its client-oriented approach to research. With operations spanning the globe, Beaufort has a proven track record working closely with clients and regulatory agencies internationally to bring our clients' products to market. Learn more at BeaufortCRO.com.
Westminster, CO – February 2, 2016 – Flagship Biosciences, Inc. announces that Beaufort, LLC., an industry leading diagnostic-CRO with extensive experience in clinical regulatory services, quality solutions and staffing solutions; will be the preferred resource to strengthen its clinical trial services for Companion Diagnostics (CDx) for its pharmaceutical clients. This announcement now provides Flagship with a partner to conduct rigorous and customized end-to-end clinical trial services for pivotal PMA registration trials for immunohistochemistry (IHC) and in-situ hybridization (ISH) based CDx. This includes support of standard, manual pathology based CDx, as well as development of advanced tissue image analysis based CDx.
Dr. Holger Lange, Chief Technology Officer at Flagship, has led the initial phases of this collaboration, which have yielded fully developed Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) for Clinical Trials according to the harmonized ICH guideline for good clinical practice (E6), to support IVD-track assay and image analysis development strategies.
"The continued collaboration will enable the development of novel, high complexity assay and image analysis interpretations to meet the needs of immuno-oncology patient selection strategies, under efforts which have been sponsored by Flagship Biosciences and its pharmaceutical customers" said Dr. Holger Lange.
"Tissue image analysis allows us to bring more complex biomarker assays into the clinic, allowing our Pharma customers to provide more effective drugs, and ultimately to save lives. The fast growing field of immuno-oncology is requiring the creation of in situ based tests which are too complex for human interpretation, and must be interpreted using tissue image analysis." said Dr. Joseph Krueger, Chief Scientific Officer. "The application and adoption of our technology is being adopted quickly in this space, and we must be sure to enable success for obtaining regulatory approval for our technology for our customers".
Flagship Biosciences, the industry leader in tissue image analysis, advances precision medicine by quantifying and simplifying complex pathology utilizing advanced image analysis technology. The company's comprehensive "fit for purpose" image analysis solutions transform conventional, subjective methods of histopathology with clear actionable data to speed global drug development and approval.
On August 14, 2015, the eMDR final rule goes into effect, requiring manufacturers to submit medical device reports (MDRs) to the FDA electronically rather than in paper form. Electronic submission expedites report processing and reduces the burden of data entry on the FDA, manufacturers, and importers. There are two options available to all reporters for submitting eMDRs: eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR).
On June 19, the FDA released an updated implementation package with the system requirements to enable manufacturers that chose the HL7 ICSR submission option to prepare for and test eMDR submissions.
As a reminder, both eSubmitter and HL7 reporting options transmit MDRs to the FDA using the FDA Electronic Submission Gateway (ESG), a secure entry point for all electronic submissions to the Agency.
Manufacturers should consider registering for an ESG account and submit a test submission as soon as possible to ensure that they are electronic submission compliant by August 14, 2015, regardless of which transmission method they choose. Manufacturers may begin testing their submissions as early as June 29, 2015.
Information on the FDA ESG and steps to obtain a production account, please visit the Electronic Submissions Gateway page.
If there's one thing that history teaches us, it's that history repeats itself. To get a picture of what the regulatory landscape will look like tomorrow, it's important to understand what it looked like yesterday, and how we got to where we are today. Through this lens, we should examine two current initiatives that could both directly and indirectly affect the regulatory and policy environment of the future: 21st Century Cures, and the proposed Regulatory Framework for In Vitro Clinical Tests.
The 21st Century Cures Act (H.R. 6), currently being discussed in the U.S. House of Representatives, addresses reforms not just for diagnostics, but across all FDA centers. It is a draft legislation created by the House Energy and Commerce Committee's leadership. Co-sponsored by Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), and released with the support from members of both parties, the bipartisan initiative aims to improve innovation for new treatments and tests, and to streamline approval efforts by the FDA.
Amendments intended to improve innovation in healthcare are not new. First came the Medical Device Amendments, added to the Food, Drug and Cosmetics Act (FD&C) in 1976, but other amendments have followed.
Among them was the Safe Medical Devices Act (SMDA), signed into law by George H.W. Bush in 1990. The SMDA primarily instituted Medical Device Reporting (MDR), which requires safety related issues, both real and potential, to be reported to the U.S. Food and Drug Administration (FDA). Few would argue that the amendment has not improved the safety of devices, but it was not focused on innovation or process improvement.
After the first two user fee-related medical device amendments in 2002 and 2007, a third amendment in 2012, called the FDA Safety and Innovation Act (FDASIA), gave the FDA a powerful drug development tool: Breakthrough Therapy Designation. This designation assists drug developers by expediting FDA review of new drugs that are supported by preliminary clinical evidence indicating the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.
FDASIA also sought to further innovation by including draft guidance on the process for approving applications for medical device clinical investigations. It also permits the FDA to review "direct" (rather than the previously cumbersome "sequential step") de novo device submissions. FDASIA also attempted to engage stakeholders more in FDA review and decision-making.
So, how should we view the 21st Century Cures initiative, given this historical perspective? It is safe to say that, once medical issues surface for discussion, the legislature generally has acted for the betterment of public health. True to that historical standard, legislation likely will pass that makes changes for the better, to improve innovation and process.
21st Century Cures also could result in an organizational restructure at the FDA. The legislation, as it currently is written, contains a great number of reforms: Clinical Laboratory Improvement Amendments (CLIA) waiver study design guidance for in vitro diagnostics (IVDs), expediting patient access, notification of marketing of certain Class I devices, priority review for breakthrough devices, telemedicine, FDA advancement of precision medicine, and improving scientific outreach for the agency. Any one of these reforms could open the door to an FDA organizational restructure and, considering the grand scope of the initiative, it is hard to imagine that some sort of organizational restructure won't occur.
However, 21st Century Cures remains silent on regulation of laboratory developed tests (LDTs). The nature of the FDA's involvement in oversight of LDTs is a hot topic within the industry, and it will be very interesting, to say the least, if the legislation moves forward without requiring or allowing that oversight.
The Regulatory Framework for In Vitro Clinical Tests proposal was a creation of the diagnostic industry, rather than government, spearheaded by the membership of AdvaMedDx, the largest group representing this industry. The proposal was developed to potentially replace the existing regulatory structure for all diagnostics (both manufacturer and LDT), regardless of site and entity. Under the proposal, the FDA, the Centers for Medicare and Medicaid Services (CMS), and other stakeholders would engage in any legislative process for statutory changes.
This proposal is related directly to the LDT Framework, merging it with the Transitional In Vitro Diagnostic Test (TIVD) proposal offered to the FDA by industry a few years ago. The TIVD eventually was embraced by Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, and a pilot program currently is underway with multiple manufacturers participating. If this program is successful — and it should be — it could change the way we look at how product approvals should occur in the future.
History dictates that some version of the framework will continue forward as-is. But it remains possible that the FDA's effort to regulate LDTs could be undermined by 21st Century Cures or something more extreme, such as a lawsuit by the lab community.
Historical knowledge provides precedence that, if we are smart, can guide current and future decision-making to benefit the public health.
Through the lens of historical knowledge, we can see that, once discussion of reform begins, movement generally continues toward action. We also can see that, when all stakeholders are involved and cooperate, public health benefits. Public meetings, agency outreach, and guidance comments are very important in developing fruitful outcomes. Today, cooperation between agency and industry is at its highest level ever. This bodes well for the future and ensures the best possible outcome for all parties.
NORFOLK, VA., May 13, 2015—Beaufort, LLC, a contract research organization (CRO), has announced that Clay Gill has been promoted to president of the company.
"This appointment constitutes a great step for Beaufort, as we further position our organization as an industry-leading CRO," said Beaufort Chairman and CEO Alfred F. Ritter, Jr.
Gill joined Beaufort in 2010 and is responsible for leading Beaufort's global operations in clinical and regulatory services, quality solutions and staffing solutions. Through her leadership, passion and vision, she successfully manages multidisciplinary teams that deliver creative and effective solutions to complex and evolving business challenges.
"Her ability to deftly align sales, marketing and operations while keenly understanding a client's individual needs is a critical factor in helping Beaufort consistently deliver program success for our clients," commented Ritter.
The Association of Medical Diagnostics Manufacturers (AMDM) held its annual meeting April 22-23, with an OIR Submissions workshop and Pre-Submissions workshop April 20-22. The two workshops were "FDA 101" for regulatory professionals, with the majority of speakers being from the FDA and covering all aspects of OIR submissions. But, even for seasoned regulatory professionals, there was plenty to learn.
For example, there was a session on FDA's Medical Device Development Tool (MDDT) pilot program, to which FDA has accepted five proposals. MDDT is a voluntary process to qualify tools that are used in the development and evaluation of medical devices outside of the regulatory submission; they are intended to save time on the development and review side. There also was a session on Unique Device Identifiers, or UDIs, which are global unique numbers that will identify almost every individual device. UDI compliance is already in effect for Class III devices and the majority of Class II devices will need to comply by September 24, 2016.
Of course, it wouldn't be an FDA-industry meeting without a discussion of Laboratory Developed Tests (LDTs). Elizabeth Hillebrenner, policy advisor at FDA, gave an overview of the proposed LDT regulation during the OIR Submissions workshop and Liz Mansfield, deputy officer director for personalized medicine at FDA, gave an update on LDTs and personalized medicine during the final day of the annual meeting. In response to the draft guidance documents, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), the FDA received more than 1,400 comments from approximately 300 individual commenters. FDA also announced that it has formed a joint task force with CMS on LDT quality requirements so as to not duplicate compliance efforts.
Overall, the AMDM workshops and annual meeting provided a great opportunity for learning and networking, allowing Beaufort to continue to stay in the forefront with regard to FDA thinking and new industry developments.
FDA recently announced that FDA and CMS will form a task force to focus on the quality requirements of laboratory developed tests (LDTs). The overall goals of the task force are to clarify the roles of the two agencies and avoid a duplication of efforts.
Last fall, FDA released two draft guidance documents here and here in which FDA would phase in the enforcement of premarket review requirements, FDA notification and MDR requirements, and the quality system regulation requirements for a subset of LDTs. FDA's goal in overseeing LDTs is to assure that they are analytically and clinically valid. "We intend to clarify the terms used so that labs may better understand what is expected of them," explained Jeffrey Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health, and Patrick H. Conway, MD, MSc, acting principal deputy administrator CMS Chief Medical Officer.
To identify areas of similarity between the FDA quality system regulation and requirements under CLIA.
To clarify responsibilities for laboratories that fall under the purview of both agencies.
To leverage joint resources to maximize efficiency.
The oversight of LDTs is highly sensitive, as it directly affects patient care. The agencies are optimistic that formalized coordination can lead to accurate tests and clinically meaningful outcome information.
A experienced regulatory consultant can help navigate the premarket review and quality system regulation requirements for LTDs.
clients achieve success while ensuring compliance with global regulations and initiatives.
biology as well as project management and regulatory affairs for IVD development.
In "Five Steps for Improving Processes in Clinical Trials," Beaufort's John Wilson introduces the five-step process for improving business processes. The article provides an introduction to the five steps, using risk-based monitoring (RBM) as an illustrative example. Wilson states that only after completing the first four steps (map, analyze, redesign, and assign resources) can we productively move on to the fifth step (implement improvements), in which a process is actually improved. This article appeared in the January 2015 Journal of Clinical Research Best Practices.
NORFOLK, Va., June 20, 2013—Beaufort has been retained by three life science companies to conduct quality oversight programs. Beaufort Quality Oversight provides an independent, continuous and comprehensive assessment of the CRO's overall process and performance.
Beaufort has been retained by a top pharmaceutical company to perform quality oversight services for two clinical trials. Beaufort senior clinical research professionals located in Europe, Asia-Pacific, North America, and South America will perform assessments of CRO and site performance at clinical sites in 38 countries.
Beaufort also has been retained by a leading provider of innovative pain management therapies to perform quality oversight services for a clinical trial of a controlled substance at 20 sites throughout the U.S. Beaufort's quality oversight services will include ongoing recommendations for improvement.
Beaufort Quality Oversight is well-aligned with regulatory authority expectations for greater oversight of CROs and other clinical service providers. Independent quality oversight also provides an opportunity for early process improvement, allowing these organizations to identify process enhancements which could improve trial conduct.
Beaufort Quality Oversight is an independent CRO assessment service that provides unbiased, independent assurance that the CRO is performing according to requirements. Beaufort's niche in the market allows the firm to establish collegial and collaborative relationships with the CROs that manage global clinical trials.
Beaufort representatives will be available to discuss quality oversight and other Beaufort services during the 49th annual meeting of the Drug Information Association, June 23–27 in Boston. Beaufort will exhibit in booth #1916 in the Exhibition Hall.
In "Some Quality Food for Thought," Beaufort's John Wilson questions why quality improvements in clinical research are so slow to come about. Wilson suggests that the industry commit to systematic, practical and measurable applications of basic principles and he cites four areas that often are overlooked. This article appeared in the October 2012 Journal of Clinical Research Best Practices.
In this Spring 2012 International Clinical Trials article, Beaufort's John Wilson argues that clinical trial sponsors can reduce the total cost of quality by implementing a third-party quality oversight program. Read the entire issue here.
In this article from the May 2012 issue of the Journal of Clinical Research Best Practices, Beaufort's John Wilson argues that clinical research can benefit from QBD. Pharmaceutical manufacturing established a risk-based approach to quality more than a decade ago, yet its adoption in clinical trials has been slow. As the pressure for fundamental change in clinical research quality continues to grow, we can learn much from our colleagues in pharmaceutical manufacturing.
In the pharmaceutical industry, quality by design (QbD) has long been applied to manufacturing. Incorporating good manufacturing practices (GMP) into the production process is expected and required by the Food and Drug Administration (FDA). Yet, rarely are QbD practices adopted before the drug enters commercial production.
The problem with not following QbD prior to commercial production is that it is extremely difficult to insert or force quality into a suboptimal process. Doing so leads to awkward and inefficient practices, duplicative efforts and "Band-Aid" approaches to quality. Building a quality pharmaceutical begins with building quality into the research and development phase.
One may argue that QbD is already built into R&D through clinical quality assurance (QA). While QA certainly is an important part of clinical research, it does not build quality into the process. Because it is traditionally conducted as an assessment at one point in time, it does not provide a continuous assessment over the course of the trial and therefore cannot be considered as part of the process.
What can pharmaceutical companies do to build quality into research and development? They can implement a third-party quality oversight program. Quality oversight upholds the principles of QbD, because it is performed over the course of the trial and it represents a simultaneous exchange of information that allows for real-time corrective and preventive action (CAPA).
Third-party quality oversight provides an unbiased and objective assessment of the vendor contract research organization (CRO) work effort. Sponsors utilize many processes to evaluate the quality of their clinical trial data; however, the bias that may exist in a long-term relationship between a sponsor and its clinical trial CRO makes it more difficult for the sponsor to adequately assess the vendor CRO's performance. Third-party quality oversight eliminates this bias and provides reliable information in real time.
An optimally structured quality oversight program should not result in any duplication of effort on the part of the sponsor. Quality oversight is all about processes and adherence to contractual and regulatory requirements. It is not about co-monitoring or re-auditing the study.
Quality oversight builds quality into a clinical trial by ensuring that CRO performance meets FDA and other regulatory body requirements and that the work also meets FDA expectations.
While sponsors always have been responsible for the quality of their vendors' work, it is now clear that sponsors also are being held directly accountable for that quality. Nowhere is this more evident than in the case of recent FDA warning letters issued to top-quality pharmaceutical firms for failure to oversee the activities of their vendors.
Problems don't have to reach warning letter status to attract the attention of regulatory authorities. Several sponsors have reported that FDA investigators are specifically asking how the sponsor oversees the activities and assures the quality of its clinical vendors. This is a legitimate question and one that industry sources expect will gain more currency as part of the inspectional process. Third-party quality oversight answers this question.
FDA's good clinical practice (GCP) requirements are quite thin—most are expectations of ethical and scientific quality standards rather than codified regulations. So how can a sponsor successfully navigate what could become a mine field of expectations? By retaining an expert with significant experience in FDA submissions.
The quality oversight provider should have extensive experience in GMP as well as GCP in order to bring GMP-quality methodology to the clinical process. The quality oversight team should be comprised of senior clinical research associates with significant experience in this type of activity. Through accrued experience, the quality oversight provider should thoroughly examine the CRO work effort and authoritatively weigh its adherence to FDA expectations.
Incorporating QbD into research and development through third-party quality oversight of clinical trials helps pharmaceutical companies ensure that FDA requirements and expectations have been met long before a drug enters commercial production. Entering production without this assurance can mean costly delays and unnecessary re-work.
This article appeared in Pharmaceutical Compliance Monitor on January 16, 2012.
Today's clinical trials require quality oversight for one simple reason: sponsors are ultimately responsible for the integrity of the data generated by their third-party vendors. This is most evident in recent FDA warning letters issued to top-quality pharmaceutical firms for failure to oversee the activities of their contract research organizations and other vendors.
Even before reaching warning letter status, problems are attracting the attention of regulatory authorities. FDA investigators are asking how sponsors oversee the activities and assure the quality of work performed by their clinical vendors. Quality oversight answers this question.
A third-party quality oversight program provides an unbiased and objective assessment of the CRO's work effort. It eliminates the inherent bias that may exist in a long-term relationship between a sponsor and its CRO—a bias that makes it difficult for the sponsor to adequately assess the CRO's performance.
An optimal quality oversight program provides real-time assessment and reporting of CRO field activity; it is not about co-monitoring or re-auditing, and it is not clinical quality assurance. Rather, it provides a comprehensive assessment of the CRO's overall process and performance.
Quality oversight is well-aligned with the FDA's Clinical Trials Transformation Initiative and, as it is accepted as a critical trial process by a large number of firms, will increase its positive impact. It also is aligned with the FDA's call for industry to be more innovative in its clinical trial work. A trial-specific, formal quality oversight plan could be part of any prospective trial review conducted under the agency's pilot initiative for adaptive clinical trials.
This article appeared in the October 2011 CenterWatch Monthly.
NORFOLK, Va., July 20, 2011—Clinical research organization (CRO) Beaufort has added quality oversight to its services for clients in the pharmaceutical, diagnostics, and medical device industries.
Beaufort has been engaged by a Top 20 Global Pharmaceutical Company to conduct quality oversight monitoring (QOM) visits for the company's clinical trials. The partnership will help the company successfully manage vendor quality and compliance during clinical trials in a uniform, quality-focused, efficient, and effective manner.
The Beaufort quality oversight team will provide the pharmaceutical company an understanding of how each of its studies is being conducted by the company's other CROs. Beaufort will not audit the CROs, but will observe, critically assess and provide objective and unbiased feedback on the respective CRO clinical research associates' level of knowledge, experience and training for the specified trials. The company can then use those observations to provide feedback to the CRO.
Beaufort is a clinical research organization dedicated to accelerating medical innovation in partnership with its clients in the pharmaceutical, diagnostics, and medical device industries. The company's range of highly customizable services includes regulatory strategy and compliance, clinical research, quality assurance, and quality oversight. For more information visit www.BeaufortCRO.com.


What a difference a week makes – last Monday, the knives were out in force for Darren Moore after Albion had succumbed to defeat at Wigan in what was their worst performance of the season. Today, Big Dave is being lauded after the Baggies comfortably beat the side that had topped the table in what was undoubtedly their best display of the campaign.
Most will point to the change in system to a 4-3-3 as the reason for the change in fortunes but, while that was obviously a key element to the victory, Darren Moore had to do much more than that to coax this performance from a side that looked at rock bottom in terms of confidence last week.
The decision to start Hal Robson-Kanu, the much-maligned centre forward, proved to be a masterstroke. Most fans will have gasped in anguish to have seen his name on the teamsheet rather than the much-anticipated return of Dwight Gayle, but the Welshman was superb through the game. His strength and ability on the ball was excellent as he acted as the point man for the majority of Albion's attacks, and his finish for the key opening goal was of the highest quality. We've seen HRK put good performances in before, although never of that quality in an Albion shirt, but his biggest problem is the ability to reproduce them on a regular basis.
Defensively, Albion were as solid as they have been all season with Ahmed Hegazi the stand out performer in the back line as he was back to his best in a familiar back four. Tosin looked far more comfortable at right back without the additional attacking responsibilities of being at wing back, and overall it was a defensive display that Tony Pulis would have been proud of. Albion's share of possession at just 28% also harked back to the Pulis era, but this side was far more inventive and attacking, and their quick breaks and high pressing meant that they controlled the match despite being without the ball for so much of it.
The win moves Albion back into the top six ahead of the international break but still five points off the lead. It remains very tight at the top of the second tier, although not as tight as in 2001/02. After 17 games that season, Albion had one more point that this season but were down in 8th place but still only five points off top spot which was occupied by Wolverhampton Wanderers; and we all know which club went up that season.
Compare that to 2000/01 when Albion also had 28 points but were in 7th spot eleven points behind leaders, Watford, with second place Fulham already seven points clear of third-placed Birmingham City. Fulham won the league with 101 points while Watford finished 9th; there is a lot that can change between now and the end of the season.


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Evelyn Ficarra
Evelyn Ficarra's Music Map
A dual citizen (UK/USA), Evelyn Ficarra was born in California in but has spent most of her life in Britain. She studied composition with Jonathan Harvey and Peter Wiegold at the University of Sussex, receiving her MA in 1986, and also studied at the National Film and Television School, graduating in Screen Music in 1994. She then had several years teaching and freelancing as a composer and sound editor, before returning to academia in 2005, having been awarded a Fellowship from the University of California, Berkeley, where she is currently working towards a PhD.
Ficarra's work has received support from the Arts Council of Great Britain, the Arts Council of England, the London Arts Board, the Sonic Arts Network, the Ralph Vaughan Williams Trust, the Hinrichsen Foundation and Poems on the Underground. She has had composer residencies at the International Electronic Music Studio (EMS) in Stockholm (1993) and the Djerassi Resident Artists Program (2004.) Her works have been short-listed for the Prix Noroit, Bourges and Luigi Russolo competitions. Her music has been heard in various formats (in concerts, theatres, music festivals, film festivals, television and radio broadcasts) in the UK, Europe, the Americas and the Far East. Her solo CD Frantic Mid-Atlantic was released by Sargasso in 1999.
Ficarra is especially interested in cross-arts work and electro-acoustic media, and in addition to her concert works has written music for dance, theatre, film and radio. Notable collaborators include Ian Spink (with Second Stride Dance Theatre , 1988, and the Dangerous Talk 1997 Choreodrome Project); Jerwood Award winning choreographer Sarah Fahie (in the company she and Ficarra started together, naked fish productions, 2002-continuing) and director Sue Buckmaster, with theatre-rites, on Shopworks (London International Festival of Theatre/Vienna Festival 2003) and In One Ear (Lyric Hammersmith and UK Tour, 2004/6.)
Recent/notable projects include Rendition, for prepared piano, harpsichord and video, a collaboration with Keynote+ (Kate Ryder and Jane Chapman) and photographer/video artist Ian Winters, which premiered at the BMIC's Cutting Edge Festival in 2006; Submarine Revisited selected for the Unknown Public's Critical Notice project 2007 and London Cries (an exploration of current London street cries) for chamber group, solo voices and tape, commissioned by Poems on the Underground and the Apollo Chamber Orchestra and premiered in the City of London Festival in 2002, and subsequently performed in a British Council concert at the Hanoi Opera House in Vietnam, 2003.
Digital Discoveries: 3 Joyrider
Digital Discoveries 6: Magenta Cuts
New Music Collections: Electronic

redpajama_set_name: RedPajamaCommonCrawl


text:
Caryomys és un gènere de rosegadors de la família dels cricètids. Les dues espècies d'aquest grup són endèmiques de les regions muntanyoses del centre de la Xina. La seva fesomia i la forma del pelatge recorden les espècies del gènere Eothenomys. Les seves dents molars manquen d'arrel. El seu hàbitat natural són els boscos humits, com ara els boscos de galeria i les selves nebuloses. El nom genèric Caryomys significa 'ratolí de les nous' en llatí.

Referències

Miodinis

redpajama_set_name: RedPajamaWikipedia


SG Number: HB13 MBPC Number: DB22(4) Walsall 4 x 1st Class Barcode Booklet Hong Kong label. Cylinder W49 W52 W61.
SG Number: HB9 MBPC Number: DB22(2) Walsall 4 x 1st Class Barcode Booklet R.J. Mitchell label. Cylinder W25 W33 W33.
SG Number: HB16 MBPC Number: DB22(6) Walsall 4 x 1st Class unfolded pane. Prince of Wales 50th Birthday label. Cylinder W56 W59 W69.
SG Number: HB9 MBPC Number: DB22(2) Walsall 4 x 1st Class unfolded pane. R.J. Mitchell label. Cylinder W25 W33 W33.
SG Number: HB13 MBPC Number: DB22(4) Walsall 4 x 1st Class unfolded pane. Hong Kong label. Cylinder W49 W52 W61.
SG Number: HB16 MBPC Number: DB22(6) Walsall 4 x 1st Class Barcode Booklet Prince of Wales 50th Birthday label. Cylinder W56 W59 W69.
SG Number: HB19 MBPC Number: DB22(9) Walsall 4 x 1st Class Barcode Booklet Postman Pat label. Torn perfs at right. Cylinder W1 W1 W1 W1 W1 W1 (W1).
SG Number: HB9 MBPC Number: DB22(2) Walsall 4 x 1st Class Barcode Booklet R.J. Mitchell label. Cylinder W27 W35 W35.
SG Number: HB19 MBPC Number: DB22(9) Walsall 4 x 1st Class Unfolded Pane Postman Pat label. Torn perfs at right. Cylinder W1 W1 W1 W1 W1 W1 (W1).
HB7 / DB22(1) Cyl Q1 Bank of England 4 x 1st Class Unfolded Pane. Trimmed at base.


The product ensures delicate cleansing of sensitive skins. It remineralizes, energises and soothes the skin thanks to its unique complex of natural Clay and organic Goji Berry extract.
Ferulic Acid has anti-age effects, it fights against free radicals, soothes erythema and prevents oxidative aggression at cellular level. Thus the fine lines, wrinkles and pigment spots are reduced, the skin elasticity is increased, the elastin and collagen production is stimulated and the destructive action of UV radiations is prevented.
Natural Clay – Has an impressive remineralizing, antitoxic, antiseptic, bactericide and disinfectant action. Restores body's radioactive balance.
Organic Goji Berry Extract – Has powerful energizing, anti-oxidative and anti-aging effect. Helps treating inflammations and other skin problems, stimulates collagen production.
The product ensures delicate cleansing for sensitive skin.
AQUA, COCAMIDOPROPYL BETAINE, GLYCERYL STEARATE, PEG-100 STEARATE, COCO-GLUCOSIDE, MAGNESIUM ALUMINUM SILICATE, CETEARYL ALCOHOL, PROPANEDIOL, LYCIUM BARBARUM FRUIT EXTRACT, ETHOXYDIGLYCOL, GLYCERIN, FERULIC ACID, PEG-40 HYDROGENATED CASTOR OIL, ORYZA SATIVA BRAN OIL, HECTORITE, XANTHAN GUM, PARFUM, METHYLISOTHIAZOLINONE, METHYLCHLOROISOTHIAZOLINONE, MAGNESIUM NITRATE, SODIUM BENZOATE, POTASSIUM SORBATE.
Apply a small quantity of cream on the wet face, avoiding the area around the eyes. Gently massage and then rinse thoroughly with plenty of water.


美國中期選舉最後48小時戰況 - 國事天下事 - 謎米香港 - Powered by Discuz!
Election Day is poised to bring heavy rain, strong wind gusts and even potential tornadoes to various states across the U.S. where voters will be casting their ballots in competitive races. In the South, severe weather threats are forecast in northern Georgia, where Democrat Stacey Abrams is vying to become the nation's first female African-American governor in a high-profile race against the state's GOP Secretary of State Brian Kemp.
Further south, pop-up thunderstorms may strike the three south Florida congressional districts where Republicans are defending against well-funded challenges by Democrats. Florida voters will also be choosing between Democrat Andrew Gillum or Republican Ron DeSantis as their next governor and between Sen. Bill Nelson and Governor Rick Scott for the Senate seat.
There's also a risk of flash floods between New York and northern New England, a region hosting multiple gubernatorial elections and some tight House contests, including the race between Democrat Antonio Delgado and Republican Rep. John Faso in New York's Hudson Valley, and the Staten Island clash between GOP Rep. Dan Donovan and progressive challenger, Max Rose.
Pennsylvania is looking at heavy rain in the morning and early afternoon. Democrats hope to pick up some seats in the state's new court-ordered congressional district map — particularly in the suburbs around Philadelphia. Severe rain is in the forecast in New Jersey, too, where Democrats are seeking to flip several Republican-held suburban districts while helping Sen. Bob Menendez avoid a humiliating upset.
CBS News elections and surveys director Anthony Salvanto points out that historically, while weather has depressed turnout in races that are not competitive, it has not been a factor in competitive races. That is, in a close race, people are willing to stand in line in the rain or wind.


text:
By the Glass
RED: (6 oz.) (9 oz.)
Malbec 12 18
Cabernet Sauvignon 13 19
Heba Toscana 14 21
Pinot Grigio 10 15
Riesling 12 18
Chardonnay Alta Maria 14 21
SPARKLING:
Serenissima Prosecco 10 15
Shiraz Woolshed, Australia/………………………… 35
Ca Del Doge Chianti (Italy)/…………………………… 39
Andeluna Malbec 1300 (Argentina)/…………………… 39
Masciarelli Montepulciano d'Abruzzo (Italy)/…………… 49
Cabernet Sauvignon, J. Mitchell, Lodi, (USA)/……………. 52
Ripasso Campolieti, L. Righetti, Veneto, (Italy)/………… 58
Fattoria Maguano Heba Toscana, (Italy)/……………...… 59
Pinot Noir, Alta Maria, Santa Barbara, Cal.(USA)/……. 60
Amarone della Valpolicella, L. Righetti, Veneto(Italy/)…… 82
Caymus, Zinfandel, Napa valley, California, (USA)/……….. 130
Serenissima Pinot Grigio, (Italy)/……………………………………. 38
Pondview Riesling, Niagara, (Canada)/………………………….. 42
Falanghina, Feudi di San Gregorio, (Italy)/…………………….. 50
Chardonnay, Alta Maria, SantaBarbara (USA)/.……………… 52
Greco di Tufo, Feudi di San Gregorio, (Italy/….……………….. 59
Sparkling Wines :
Serenissima Prosecco, Piccolo (200 ml.), (Italy)/……………….. 18
Serenissima Prosecco, (Italy)/…………………………………………… 39
2017 Conegliano, Valdobbiadene Prosecco Superiore DOCG/ 59
Draft Beer – Krombacher / 8.00
Bottled Beers
Moretti / 8.00
Manebrea Ambrata / 8.00
Manebrea Rossa / 8.50
Peroni / 7.50
Moosehead / 7.00
Birra Italia (Artisan) / 9.00
Mill Street organic apple cider beer / 7.50
Artisan Beers
Our artisan beers, "32" produced and imported from Venezia are in 750 ml bottles, corked like wine bottles, and are extremely popular in Italy because they are served like wine and made for sharing. There are 5 flavours from which to choose, depending on your particular preferences.
32.00 each
32 Audace 32 Curmi 32 Oppale 32 Nebra 32 Admiral
Description Strong, spiced top-fermented ale, bottle conditioned Spiced, top-fermented ale made with spelt & barley malt, bottle conditioned Highly hopped, top-fermented beer, bottle conditioned Amber coloured, top-fermented beer bottle conditioned Amber coloured, top-fermented beer with ruby glints, bottle conditioned
Bouquet Hints of citrus, warm, yellow flowers, almond & peach in syrup Floral notes, aromas of exotic fruit, slightly citrussy Notes of caramel & toffee, fruity hints of raw pineapple Soft aromas of white flowers, caramel, and a gentle spiciness Cured & caramelized, herbaceous hints, slight acidity
Type of Beer Belgian strong ale Wheat beer Hopped ale Amber coloured beer Scottish Red
% Alcohol 8.4% 5.8% 5.5% 8% 6.3%
Excellent with Rich food but without greasy sauces, smoked or savoury dishes Raw veggies, delicate foods,such as fish or white meat Fatty and rich foods On its own on any occasion, excellent at end of dinner Game such as pigeon, hare, venison, wild boar
Aperol/Campari Spritz 12.00
Aperol, campari, prosecco, soda
Americano 9.50
Campari, martini rosso, soda
Bellini/Rossini 12.00
Fresh peach, strawberry puree, prosecco
Bloody Caesar 12.00
Vodka, Clamato, worcester, tabasco, lemon
Mai Tai 12.00
Rum (white, ambrato & overproof), orange curacao, lime juice, almond syrup
Old fashioned 9.00
Bourbon, angostura bitter, sugar cube
Long island ice tea 12.00
Vodka, gin, tequila, rum, triple sec, lemon juice, coke
Margarita 12.00
Tequila, triple sec, lime juice
Daiquiri 9.00
Havana 3y, lime juice, simple syrup
Cosmopolitan 9.00
Vodka citron, triple sec, cranberry, lime
Negroni 10.00
Gin, campari, martini rosso
Mojito 10.00
Havana 3y, mint, white cane sugar,soda
Martini 12.00
Vodka, Gin, Dry Martini
Manhattan 10.00
Angostura bitter, rye, Martini Rosso
Bartender's Specialty 12.00
Always a welcome surprise!
Coffee, Liqueurs & Specialty Shots
Single 3.25
Double 4.25
Macchiato 3.75
Corretto 5.00
Wide selection of teas available 3.25
Digestivi
Montenegro 6.00
Amaro nonino 9.00
Amaro del capo 6.00
Sambuca 5.50
Baileys 6.00
Limoncello 5.00
Amaretto L. Inga 8.00
Grappa 66 la bianca 8.00
Coffee Specialties
Cappuccino 4.25
Caffelatte 4.25
Latte macchiato 4.00
Baileys foam 6.50
Decaf (coffee or tea)
Grappa 66 invecchiata 9.50
Barolo grappa 18.00
Amarone grappa 18.00
Brunello grappa 18.00
Gin Panarea 7.00
Whisky Gold Label J.Walker 13.00
Hennessy VSOP 15.00
Oban Scotch aged 14 yrs. 18.00
Monday 12:00 pm - 10:00 pm
Tuesday 12:00 pm - 10:00 pm
Wednesday 12:00 pm - 10:00 pm
Thursday 12:00 pm - 10:00 pm
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Sunday Closed for event bookings
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King City, ON


text:
Home » Bifocal Stereoscopic Vision for Intelligent Vehicles
Bifocal Stereoscopic Vision for Intelligent Vehicles
Rovira-Más, Francisco; Qi Wang; Qin Zhang
International Journal of Vehicular Technology;2009, Vol. 2009, p1
The numerous benefits of real-time 3D awareness for autonomous vehicles have motivated the incorporation of stereo cameras to the perception units of intelligent vehicles. The availability of the distance between camera and objects is essential for such applications as automatic guidance and safeguarding; however, a poor estimation of the position of the objects in front of the vehicle can result in dangerous actions. There is an emphasis, therefore, in the design of perception engines that can make available a rich and reliable interval of ranges in front of the camera. The objective of this research is to develop a stereo head that is capable of capturing 3D information from two cameras simultaneously, sensing different, but complementary, fields of view. In order to do so, the concept of bifocal perception was defined and physically materialized in an experimental bifocal stereo camera. The assembled system was validated through field tests, and results showed that each stereo pair of the head excelled at a singular range interval. The fusion of both intervals led to a more faithful representation of reality.
Phoenix 3-D From Mars. Starkman, David; Dennis, John // Stereo World;Jul/Aug2008, Vol. 34 Issue 1, p3
The article discusses the activation of the Surface Stereo Imager (SSI) camera during the space expedition of the National Aeronautics and Space Administration's (NASA) Phoenix spacecraft on May 25, 2008 in Mars. Report says, the robotic arm operation of Phoenix is aided by SSI's stereo data...
Shooting 3D Without a Stereo Camera. Saxon, David // PSA Journal;May2002, Vol. 68 Issue 5, p33
Presents tips for taking three-dimensional photographs without using a stereo camera. Experimentation made; Use of negative film; Limitations and advantages of the technique.
Mapping and Localization in 3D Environments Using a 2D Laser Scanner and a Stereo Camera. KUEN-HAN LIN; CHUN-HUA CHANG; DOPFER, ANDREAS; CHIEH-CHIH WANG // Journal of Information Science & Engineering;Jan2012, Vol. 28 Issue 1, p131
2D laser scanners have been widely used for accomplishing a number of challenging AI and robotics tasks such as mapping of large environments and localization in highly dynamic environments. However, using only one 2D laser scanner could be insufficient and less reliable for accomplishing tasks...
Stereoscopic Scene Flow Computation for 3D Motion Understanding. Wedel, Andreas; Brox, Thomas; Vaudrey, Tobi; Rabe, Clemens; Franke, Uwe; Cremers, Daniel // International Journal of Computer Vision;Oct2011, Vol. 95 Issue 1, p29
Building upon recent developments in optical flow and stereo matching estimation, we propose a variational framework for the estimation of stereoscopic scene flow, i.e., the motion of points in the three-dimensional world from stereo image sequences. The proposed algorithm takes into account...
Stereo vision uses a single lens/camera combination. Wilson, Andrew // Vision Systems Design;Jul2010, Vol. 15 Issue 7, p8
The article discusses about applying the three-dimensional (3-D) vision using a stereo camera. The stereo camera from ISee3D integrates both a camera and a lens along with a mechanical or liquid-crystal optical switching mechanism to provide 3-D visual effects. The ISee3D utilizes the single...
3 IS A MAGIC NUMBER. // MacUser;Sep2013, Vol. 29 Issue 10, p22
The article discusses the state of stereoscopic 3D technology in 2013. According to Jonathan Tustain at 3dfocus.co.uk, despite the high costs of blockbuster 3D production, at least 28 mainstream 3D films are scheduled for 2013. The author adds that sales of 3D Blu-rays nearly doubled in 2012...
Imag(in)e That! Fanelli, James L. // Review of Optometry;4/15/2013, Vol. 150 Issue 4, p80
The article presents a case study related to the diverse testing results seen following the evaluation of optic nerves in a patient suffering from glaucoma. It reports that after putting through stereoscopic, a three- dimensional (3D) imaging test, the patient's optic nerves revealed cup-to-dis...
3D Map Creation with Vehicle Mounted Single Stereoscopic Camera Reducing Influences Due to Vehicle Motions. Arai, Kohei // International Journal of Research & Reviews in Computer Science;Aug2011, Vol. 2 Issue 4, p1056
Three dimensional map creations with an vehicle mounted single stereoscopic camera is proposed for reducing influence due to vehicle motions. Epipoler condition between two stereo pair of image planes has to be established for creation of three dimensional maps. If the condition is violated due...
Development of a real-time stereo TEM. Tanaka, H.; Kojima, T.; Tsuruta, H.; Chen, J.; Tanji, T.; Ichihashi, M. // Journal of Materials Science;May2006, Vol. 41 Issue 9, p2659
We have developed a real-time stereo transmission electron microscope (TEM) with tilting illumination. This system allows us to observe three-dimensional (3-D) images directly with a video-rate of 1/30 s. The system comprises two electrostatic deflectors. The first, included in the illumination...


Saturday 14 September sees the flinging open of field gates and winery doors as Hogs Back's latest major drinks player, Greyfriars Vineyard, holds its first open day under new ownership.
Perhaps best known in drinks terms for its recently re-energised brewery, the Hogs Back near Guildford is also home to acres of south-facing chalk downland. Since taking over at Greyfriars Vineyard in 2010, Hilary and Mike Wagstaff have expanded the number of vines thirtyfold, taking the total to 45,000 over 30 acres.
Following England's successful debut performance in the 2012 Sommelier Wine Awards, English and Welsh wine have been given their own sparkling wine category, alongside Prosecco, Champagne and sparkling wines from other countries.
As deputy director of the competition, I must declare an interest in this. It was wonderful to see the English contingent come from nowhere to score a dozen medals – only three less than California.
Three of these medals were Gold, plus both a Critics Choice trophy for RidgeView's "textured" Knightsbridge Blanc de Noirs 2009 and a By the Glass gong for Furleigh Estate's "complex" Classic Cuvée Brut.


…grip my head with both hands lest it explode over news of the book design exhibition curated and featuring work by #girlcrush Irma Boom, creator of 300 incredible books, including what's been rightly called "the most beautiful book in the world." Irma Boom! Beautiful books! Amsterdam! Oh damn, that's far.
…die over how freaking cute this picture of husband and wife Steve Heller and Louise Fili is, taken behind the scenes of Print's new Hollywood: New York issue.
…place my bets on the predictions by design and tech sensei John Maeda in his new Design in Tech Report, like why design will actually come to mean less the more specialized the industry becomes and why VCs will become designers new BFFs.
…definitely think the sign on the right is more legible, no? If you disagree, you're not alone. The clarity of Clearview, the typeface in question, is up for debate right now between its designer and the Highway Administration (and I can't help but root for the designer).
…let my inner historical-collection geek flag fly upon discovering Pantone's predecessor, the Forbes Pigment Collection, an insanely meticulous and unbelievably impressive repository of the physical sources for more than 2,500 colors. Housed at the Harvard Library, the project was originally launched in the early 20th century as a way to authenticate pigments in classical paintings, and now holds some of the rarest—and most toxic—materials used in everything from fine art to Legos. Yeah, don't go chewing on pre-1970s Lego bricks, there's actual cadmium in those.
…have a nerd-redemption moment with Graphic Stamps, an ode to beautifully designed stamps, the latest release from Unit Editions. The book honors "the often-neglected aesthetic and technical brilliance of postage stamps from around the world," and reminds me how amazing my 6th-grade collection could have been had I not abandoned it for less nerdy pursuits.
…offer major hand claps to Mother's design director Alex Proba, who did the 100 Days project one better with her daily poster designs, which just reached its 1,000th day milestone. You can follow her ongoing practice to fight creative blocks on Instagram @alexproba and keep an eye out for future designer collabs (like this one, with Eye on Design fave Karan Singh).
…agree 1,000,000% that Trump's latest Instagram anti-Hillary Clinton ad is, like everything else about him, beyond offensive, but appreciate the public outrage so much more because it's as much over his campaign manager's lazy font choice as it is about his egregious sound editing of a dog barking over Clinton's speech (among many other terrible editing choices).
You don't need to be a local to tell the ODE that you won't work for free. Contact them at ryan.kelly@doit.ri.gov.


ClueTrust is happy to announce the immediate availability of Cartographica 1.2.4, a bug fix release for Cartographica 1.2. This release contains no new features, and fixes a handful of bugs (some peculiar to OS X 10.7 Lion). The full release notes are available at MacGIS.com.


text:
Q: Finding a continuous probability distribution The support of a continuous random variables is $\text{{$u;f_X(u)>0$}}$.
This clue has been provided: "A theorem states that the sequence $(E[X^n])_n$ for all natural $n$ completely characterises the distribution of random variables with bounded support; in other words two different distributions with bounded support differ in some of the moments.
Suppose $E[X^i]=\frac{1}{i+1}$ for all natural $i$. Find the distribution of $X$.
How on earth does one approach this problem? The clue has only confused me.
So far all I have ascertained is that the sequence in question is $$(E[X^n])_n=\frac{1}2,\frac{1}3,\frac{1}4...\frac{1}n$$
How do I approach this?

redpajama_set_name: RedPajamaStackExchange


text:
<?php

namespace App\Http\Controllers;

use App\Share;
use Illuminate\Http\Request;

class ShareController extends Controller
{
	function __construct()
	{
		$this->middleware('auth');
	}

	/**
     * Display a listing of the resource.
     *
     * @return \Illuminate\Http\Response
     */
    public function index()
    {
        //
    }

    /**
     * Show the form for creating a new resource.
     *
     * @return \Illuminate\Http\Response
     */
    public function create()
    {
        //
    }

    /**
     * Store a newly created resource in storage.
     *
     * @param  \Illuminate\Http\Request  $request
     * @return \Illuminate\Http\Response
     */
    public function store(Request $request)
    {
        //
    }

    /**
     * Display the specified resource.
     *
     * @param  \App\Share  $share
     * @return \Illuminate\Http\Response
     */
    public function show(Share $share)
    {
        //
    }

    /**
     * Show the form for editing the specified resource.
     *
     * @param  \App\Share  $share
     * @return \Illuminate\Http\Response
     */
    public function edit(Share $share)
    {
        //
    }

    /**
     * Update the specified resource in storage.
     *
     * @param  \Illuminate\Http\Request  $request
     * @param  \App\Share  $share
     * @return \Illuminate\Http\Response
     */
    public function update(Request $request, Share $share)
    {
        //
    }

    /**
     * Remove the specified resource from storage.
     *
     * @param  \App\Share  $share
     * @return \Illuminate\Http\Response
     */
    public function destroy(Share $share)
    {
        //
    }
}

redpajama_set_name: RedPajamaGithub


text:
Devolver Digital to bring indie horror bloodbath 'Carrion' to Xbox One
It looks like players interested in playing the monster in Devolver Digital's indie reverse-horror 'Carrion' will also have the opportunity to play on Xbox One.
Devolver Digital's reverse-horror title Carrion has always been a brutally interesting endeavor. Instead of fighting against or containing the hideously grotesque monster, you are the monster and your only task is surviving, devouring, and absorbing the foolish scientists, guards, and other meaty creatures who dare to get in your way in the harrowing confines of the facility that imprisoned you. It also turns out that Steam players won't be having all the fun. Devolver Digital has just announced that Carrion will also be launching on Xbox One.
Devolver announced their plans to launch Carrion on Xbox One with a new trailer launched on the Devolver Digital YouTube channel on November 11, 2019. Alongside a vibrant display of meaty goodness that ends horribly for a slew of humans, the brief new trailer puts the Xbox logo bright and prominently on the scene of the carnage. Alongside this trailer, Devolver and game developer Phobia Game Studio announced in a press release that Carrion would actually be launching directly beside the PC launch in 2020.
Revealed at E3 2019, Phobia Game Studio made a splash with their "reverse-horror" title in which players take on the role of an amorphous creature imprisoned in an unknown facility. As you seek to escape, you'll come across and kill human foes, grow, and evolve, taking on a number of new abilities in your rabid quest to get out and destroy everything that stands in your way. Humans will panic and do everything they can to contain or kill the creature as chaos and fear spreads rampantly from the creature's increasingly deadly onslaught.
Carrion doesn't have a confirmed release date just yet, but is slated to be playable next at the Xbox X019 event in London on the weekend of November 14 through 16. Has Carrion caught your interest yet? Will you be checking it out when it becomes available? As we await more details on the game, PC players can find and wishlist the game on Steam.
TJ Denzer is a player with a passion for games that has dominated a lifetime. When he's not handing out beatdowns in the latest fighting games, exploring video game history, or playing through RPGs with his partner, he's searching for new food and drinks in the constant pursuit of good times with good people inside and outside the South Texas area. You can also find him on Twitter @JohnnyChugs.
Xbox exclusive games coming in 2021
TJ Denzer posted a new article, Devolver Digital to bring indie horror bloodbath 'Carrion' to Xbox One


Check out 103 great deals in Curling. Take a look here for other great listings such as: used clubs, pin curl, trophy awards, trophy club or vintage club to browse for more great Team Sports bargains on Sporting Goods items from HockeySandwich.com.
If you're looking in Curling you might also try searching for: Curling, award, trophy, awards, trophies and used.


text:
Zoom access
Paper Presentation Recording Instructions
Camera-ready Submission (Confy+)
Professor Abbas Jamalipour
Abbas Jamalipour; PhD Fellow IEEE Fellow IEICE Fellow IEA
Professor of Ubiquitous Mobile Networking, The University of Sydney
President, IEEE Vehicular Technology Society
Keynote title: Edge Computing and Aerial Support in 6G Wireless Networks
Abstract: Research on the Sixth Generation Cellular Networks (6G) has already been started while the deployment of the new Fifth Generation Cellular Networks (5G) has only got started around the world. It would take some time before we get the full picture of credibility of 5G, but researchers already know that it would suffer from a range of shortcomings with the introduction of new applications and thus; the need for work on its successor 6G. What we know and expect at this time is that we still need to make users closer to the network edges, thus the inclusion of edge computing; and that we need more autonomous and intelligent techniques in the form of advanced machine learning and artificial intelligence. At the same time, we know that terrestrial network components will have fundamentally physical limitations in providing coverage and accessibility needed in future networks. That would bring the involvement of more of aerial support including drones and low earth orbit satellites. This talk will provide some visionary concepts of the future mobile networks that contemplate edge computing and aerial support using results from some existing intelligent techniques.
Bio: Abbas Jamalipour is the chair Professor of Ubiquitous Mobile Networking at the University of Sydney, Australia, and holds a PhD in Electrical Engineering from Nagoya University, Japan. He is a Fellow of the Institute of Electrical and Electronics Engineers (IEEE), the Institute of Electrical, Information, and Communication Engineers (IEICE), and the Institution of Engineers Australia (IEA), an ACM Professional Member, and an IEEE Distinguished Speaker. He has authored nine technical books, eleven book chapters, over 550 technical papers, and five patents, all in the field of wireless communications. Dr. Jamalipour is the President and an elected member of the Board of Governors of the IEEE Vehicular Technology Society. He was the Editor-in-Chief IEEE Wireless Communications, Vice President-Conferences and a member of Board of Governors of the IEEE Communications Society. He serves as an Editor of IEEE Access, IEEE Transactions on Vehicular Technology, and several other journals. He has been a General Chair or Technical Program Chair for a number of conferences, including IEEE ICC, GLOBECOM, VTC, WCNC and PIMRC. He is the recipient of a number of prestigious IEEE technical achievement awards, as well as over fifteen Best Paper Awards.
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Find hotel near Rheinische Landesmuseum B ..
The Museum Rheinisch-Westfälischer Alterthümer is managed exclusively by the Rhineland Landscape Association.The present day museum has evolved from the "Museum of Antiquities" (Museum Rheinisch-Westfälischer Alterthümer) and the Provincial Museum.
Founded in 1820 by the decree of Prussian Chancellor, Karl August von Hardenberg, the museum houses many ancient figures dating back to the Roman era. It has numerous collections of archaeology and art in Nordrhein-Westfalia.
Apart from the exhibitions, the museum also hosts events and cinema shows inside the auditorium. Subject areas of the museum also display literature exhibition catalogues, trade publications and gift gallery.
The museum hosts guided tours for children during holidays.
Family Day is celebrated on special occasions.
It is a conference venue for political and economic groups. It may get crowded at times.
It is a great spot to catch-up with press conferences, book releases and literature workshops.
Cinema shows are organized projecting foreign films.
Don't click photographs without permission.
Parking for handicapped with railed ramp is available.
Borrowed wheelchair services are available.
Scholarly demonstrations are conducted during the day time. Maintain silence and ensure that the kids don't trespass into restricted areas.
Children below 18 years: Free of cost.
Group tours for school children: 10 am- 6 pm.
How popular is Rheinische Landesmuseum Bonn?
People normally club together Deutsches Museum Bonn and Arboretum Park Haerle while planning their visit to Rheinische Landesmuseum Bonn.
Very cool place. We went for the knights and castle exhibit. 20 euros for two adults and a kid. Enough to look at. Some in English and German and also Dutch. Cafe attached. Right near main train station. Kids loved it. Activities for them to do.
Another Landesmuseum of outstanding quality. The Roman collection is superb but it's the early mediaeval collection which makes it worth going out of your way to visit. The "Lord of Morken" exhibit is particularly impressive. There is also a very good bookshop, something it is frequently lacking in museums both in Germany and elsewhere.
The museum is a little boring. There are many pictures, statues, small objects, but not too much information. I haven't got the way they organized the exposition, periods are all messed up. Perhaps it's me who went a wrong way. But I liked the temporal exposition consecrated to the medieval knights.
Fascinating artifacts and art works dating from pre-history to modern day. The museum is strangely laid out and all information is in German language only. I looked at everything on four floors and it took me about 2.5 hours, so don't plan an entire day for your visit. Definitely worth the time!


text:
Being out-numbered means being out of power | Bill Cotterell
Republicans got everything they wanted this legislative session — well, almost everything
Being out-numbered means being out of power | Bill Cotterell Republicans got everything they wanted this legislative session — well, almost everything Check out this story on tallahassee.com: https://www.tallahassee.com/story/opinion/2019/05/09/being-out-numbered-means-being-out-power-bill-cotterell/1133117001/
Bill Cotterell, Capital Curmudgeon Published 5:00 a.m. ET May 9, 2019
When Daniel Webster became speaker of the House in 1996, the first Republican to fill that post in more than a century, he sometimes told a tale of his own introduction to the partisan politics of the Florida Legislature.
An eager, young and maybe slightly naïve politician from the Orlando area, Webster carefully prepared to discuss his first bill in a committee meeting in 1980. The panel rejected his proposal out of hand – then moved on to an almost identical bill by a Democrat, and quickly passed it.
Webster, now a congressman from Central Florida, got the message. In the era of Gov. Bob Graham, when Democrats held all six Cabinet seats and had big majorities in both chambers of the Legislature, Republicans were more tolerated than respected.
The leadership wanted the bill, it just didn't want his bill. So Webster listened and learned for the next 16 years as the balance of power tilted inexorably to the GOP. Republicans took over the Senate in 1994 and won the House two years later.
With a 61-59 majority (Democrats even tried to persuade a Republican or two to cross over and make their guy speaker), Speaker Webster couldn't get all wild and crazy conservative. Especially not with a Democrat, Lawton Chiles, still in office. But Webster moved the GOP to the front of the House chamber and the trend line has not receded over the past 22 years.
In the five days since the 2019 legislative session ended, you've probably seen stories about how the Republicans got everything they wanted — well, almost everything. They dominated debate on such matters as arming school teachers, forbidding local governments to ban plastic straws, impeding restoration of felon voting rights (despite a constitutional amendment directing them to do so) and forbidding "sanctuary city" policies.
Democratic legislators, meanwhile, were really, really good at holding news conferences in front of the House and Senate chambers. It was inside those chambers that they were not so impressive.
Late in the session, first-term Rep. Adam Hattersley of Hillsborough County ran the numbers and posted a little Facebook video briefing that showed just how politically lopsided legislating has been. This is like documenting, to an engineering certainty, that the sun rises in the east.
He did it with two weeks left in the session, but the numbers didn't change significantly in the final days.
There were, for instance, 71 Republicans and 46 Democrats in the House at the time – 60.7 percent to 39.3 percent – and, coincidentally, Democrats offered 296 policy bills and Republicans sponsored 457 proposals. That works out to 60.7 percent to 39.3 percent, reflecting the partisan makeup of the House itself.
OK, fair enough so far. But not all bills are created equal, and sponsorship is just a clerical function. Moving them is something else.
Every bill gets sent to two or three committees, usually, and it's up to the leadership which bills get heard. Hattersley charted 170 hearings for those 296 bills sponsored by Democrats, compared to 857 discussions on GOP-sponsored policy proposals. So just under 61 percent of the House members got over 83 percent of the hearings.
That ratio was reflected in how many bills got out of committee and reached the House floor – 50 by Democrats, 270 by Republicans. Again, an .840 batting average for the House GOP.
And how many passed the House? Democrats, 21, Republicans 151 – nearly 89 percent for the majority party.
Hattersley isn't complaining, he's explaining. In an interview, he noted that Democrats did all right with a needle-exchange proposal and a measure providing some measure of dignity for incarcerated women. But those hardly compare to guns in school rooms or making local governments cooperate with federal immigration authorities.
And he said 13 of his Democratic colleagues didn't get a hearing on anything. No Republican member went 0-for-Session, he said.
Hattersley, who flipped a Republican-held seat last November, said the solution for his party is obvious: Win some elections. As he points out in his video, 37 percent of Florida's 13.4 million voters are Democrats and 35 percent are Republicans. The rest are independents or members of splinter parties.
Gov. Ron DeSantis and the Republican House and Senate will control redistricting after next year's census, subject to court challenges.
It probably won't take 122 years for the Democrats to regain a House majority, as it took the Republicans before Dan Webster.
It'll just seem that long.
Bill Cotterell is a retired Tallahassee Democrat Capitol reporter who writes a twice-weekly column. He can be reached at bcotterell@tallahassee.com.
Read or Share this story: https://www.tallahassee.com/story/opinion/2019/05/09/being-out-numbered-means-being-out-power-bill-cotterell/1133117001/


Create positive change. Connect with peers. Serve your community. Incubate ideas. Get involved.
There's more to the college experience than the classroom. Finding activities that you're passionate about, and breaking the college bubble to venture into new spaces and diverse communities will open your mind and expand your world to creative and professional opportunities. And if you don't find what you're looking for, we invite you to create it.


text:
Jyothika And Karthis Film With Jeethu Joseph Starts Rolling
Jyothika and Karthi's film with Jeethu Joseph starts rolling
Written By Xappie Desk | Updated: April 30, 2019 09:50 IST
It's time for the most proficient actors and technicians team up for an intriguing film. The buzz about Karthi and Jyotika sharing the screen space for the first time in a film has been adding up more excitement among the fans. The official announcement regarding the film is out now with the first look that has instantly grabbed everyone's attention.
The film is directed by most celebrated and ace filmmaker Jeethu Joseph (Drishyam, Papanasam fame) and is produced by Suraj from Parallel Minds Productions in association with Viacom18 Studios. Sathyaraj will be seen playing an important role alongside Anson Paul (Remo, blockbuster hit Abrahaminte Santhathikal fame) and few more to be included in the cast shortly.
Govind Vasantha (96 fame) is composing music and well-celebrated RD Rajashekar is handling cinematography.
The shooting for this film commenced today in Goa and is scheduled for October 2019 release.


text:
american journal of mathematics
As of June, 2012, the editors are Christopher D. Sogge, editor-in-chief (The Johns Hopkins University), William Minicozzi II (Massachusetts Institute of Technology), Freydoon Shahidi (Purdue University), and Vyacheslav Shokurov (The Johns Hopkins University).
Moving walls are generally represented in years. American Journal of Mathematics.
According to the Journal Citation Reports, its 2009 impact factor is 1.337, ranking it 22nd out of 255 journals in the category "Mathematics".[4]. The oldest mathematics journal in the Western Hemisphere in continuous publication, the American Journal of Mathematics ranks as one of the most respected and celebrated journals in its field.
Evolution of the number of total citation per document and external citation per document (i.e.
DEPARTMENT OF MATHEMATICS, THE JOHNS HOPKINS UNIVERSITY . In rare instances, a Then with volume 16 it was "Edited by Thomas Craig with the Co-operation of Simon Newcomb" until 1898.[2]. Published since 1878, the Journal has earned its reputation by presenting pioneering mathematical papers. For volume 7 Simon Newcomb became chief editor with Craig managing until 1894. JSTOR®, the JSTOR logo, JPASS®, Artstor®, Reveal Digital™ and ITHAKA® are registered trademarks of ITHAKA. It measures the scientific influence of the average article in a journal, it expresses how central to the global scientific discussion an average article of the journal is.
The SJR is a size-independent prestige indicator that ranks journals by their 'average prestige per article'. 1 - Vol. The purpose is to have a forum in which general doubts about the processes of publication in the journal, experiences and other issues derived from the publication of papers are resolved. The oldest mathematics journal in continuous publication in the Western Hemisphere, American Journal of Mathematics ranks as one of the most respected and celebrated journals in its field. Fax: 410-516-5549 Journal Self-citation is defined as the number of citation from a journal citing article to articles published by the same journal. Email(will not be published) Published since 1878, the Journal has earned its reputation by presenting pioneering mathematical papers. 6). Q1 (green) comprises the quarter of the journals with the highest values, Q2 (yellow) the second highest values, Q3 (orange) the third highest values and Q4 (red) the lowest values. Published since 1878, the Journal has earned its reputation by … journal self-citations removed) received by a journal's published documents during the three previous years. Other notable mathematicians who have served as editors or editorial associates of the journal include Frank Morley, Oscar Zariski, Lars Ahlfors, Hermann Weyl, Wei-Liang Chow, S. S. Chern, André Weil, Harish-Chandra, Jean Dieudonné, Henri Cartan, Stephen Smale, Jun-Ichi Igusa, and Joseph A. Shalika. The American Journal of Mathematics is the oldest continuously published mathematical journal in the United States,[1] established in 1878 at the Johns Hopkins University by James Joseph Sylvester, an English-born mathematician who also served as the journal's editor-in-chief from its inception through early 1884. Evolution of the total number of citations and journal's self-citations received by a journal's published documents during the three previous years. * Required. The oldest mathematics journal in the Western Hemisphere in continuous publication, the American Journal of Mathematics ranks as one of the most respected and celebrated journals in its field. Description: The oldest mathematics journal in the Western Hemisphere in continuous publication, the American Journal of Mathematics ranks as one of the most respected and celebrated journals in its field. Published since 1878, the Journal has earned its reputation by presenting pioneering mathematical papers. Fields medalist Cédric Villani has speculated that "the most famous article in its long history" may be a 1958 paper by John Nash, "Continuity of solutions of parabolic and elliptic equations". Initially W. E. Story was associate editor in charge; he was replaced by Thomas Craig in 1880. The users of Scimago Journal & Country Rank have the possibility to dialogue through comments linked to a specific journal. publisher has elected to have a "zero" moving wall, so their current It does not specialize, but instead publishes articles of broad appeal covering the major areas of contemporary mathematics. Note: In calculating the moving wall, the current year is not counted. The two years line is equivalent to journal impact factor ™ (Thomson Reuters) metric. Phone: 410-516-7411.
The set of journals have been ranked according to their SJR and divided into four equal groups, four quartiles. Baltimore, MD 21218. ajm@math.jhu.edu.
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american journal of mathematics 2020


text:
using System;
namespace HolisticWare.Ph4ct3x.Sports.Judo
{
    public class Competition
    {
        public Competition()
        {
        }
    }
}


The Royal Institute for Cultural Heritage (KIK/IRPA) organised the Bruegel Success Story Colloquium, which took place in Brussels from 12 to 14 September 2018. The colloquium was intended for curators, art historians, conservators and scientists studying painting from the Southern Netherlands in the 16th century.
The biennial colloquium is alternately organised by KIK/IRPA, UCL, KU Leuven and Musea Brugge. This year, the Royal Museums of Fine Arts of Belgium and the University of Liège were joint organizers.


text:
package main

import (
	"encoding/json"
	"net/http"
)

func postPlanHandler(w http.ResponseWriter, r *http.Request, u *user, planID string, db db) {
	resp := newJsonResponse(w)
	body := goals{}

	if err := json.NewDecoder(r.Body).Decode(&body); err != nil {
		resp.AddError(err).Write(http.StatusBadRequest)
		return
	}

	var p plan
	found, err := db.LoadPlan(planID, &p)

	if err != nil {
		resp.AddError(err).Write(http.StatusInternalServerError)
		return
	}

	if found {
		resp.AddErrorMessage("plan already exist").Write(http.StatusBadRequest)
		return
	}

	year, week, userID := planKeyToParts(planID)

	var planUser user
	if found, err := db.LoadUser(userID, &planUser); !found || err != nil {
		resp.AddErrorMessage("user could not be loaded").
			Write(http.StatusInternalServerError)
		return
	}

	newPlan, err := newPlan(&planUser, year, week, body)

	if err != nil {
		resp.AddError(err).Write(http.StatusBadRequest)
		return
	}

	if ok, msg := u.CanEdit(newPlan); !ok {
		resp.AddErrorMessage(msg).Write(http.StatusForbidden)
	}

	if err = db.SavePlan(newPlan); err != nil {
		resp.AddError(err).Write(http.StatusInternalServerError)
		return
	}

	resp.SetData(plans{*newPlan}).Write(http.StatusOK)
}


text:
ZTE is kickstarting an eye-tracking smartphone called 'Hawkeye"
Image: ZTE
By Karissa Bell 2017-01-05 02:07:55 UTC
LAS VEGAS — Chinese smartphone maker ZTE is turning to a slightly more unconventional method to launch its next phone: Kickstarter.
The company announced Wednesday that it is using the crowdfunding platform to fund its next smartphone, an eye-tracking handset dubbed "Hawkeye."
SEE ALSO: Acer's new gaming monitor tracks your eye movement
The company didn't reveal many specs for the upcoming device, which is currently still a prototype. But ZTE said the phone will have a 5.5-inch HD display, dual-SIM slots, a fingerprint sensor and expandable memory. Like the company's other phones, Hawkeye will run Android and come unlocked.
But the most interesting aspect of the phone is the feature that likely gave it the "Hawkeye" name: eye tracking. Powered by the phone's front-facing camera, the phone will track users' eye movements to allow them to scroll through their reading material and other content.
The phone will also ship with a "self adhesive" case to further enable hands-free use. The case is made out of an unnamed material that allows it to "stick against most vertical surfaces," according to the company.
The Hawkeye costs $199 during the Kickstarter (ZTE has set a $500,000 goal) and the company says it expects to ship the device by September 2017.
BONUS: BlackBerry Mercury preview
Topics: CES, CES 2017, Kickstarter, Mobile, Tech, zte