Most adults who've attended an event titled "The Sustainability Workshop," probably sat in a room for six long hours, scribbled some notes on stormwater issues or soil erosion, ate a few crusty danish, (awkwardly) networked, and then went home soon to forget most of what they learned. However, if you are a 17-year-old student in Philadelphia, attending The Sustainability Workshop (TSW) it means that you have opted into a yearlong alternative high school experience whose mission is "to unleash your creative and intellectual potential to solve the world's toughest problems." These exceptional high school seniors trade in their old classrooms for the chance to work on real projects including the Hybrid X car design challenge. And starting next year, TSW will be expanding into a full four year high school.
Founded as an afterschool program 15 years ago by teacher and engineer Simon Hauger to engage his students in math, science and engineering, the students at TSW have won multiple national competitions with the hybrid vehicles they designed and built. The biggest win came this spring when the School District of Philadelphia announced an award through their partner, Philadelphia School Partnership, of $6 million to three high-performing schools: Science Leadership Academy, Hill Freedman Middle School, and The Sustainability Workshop (which will receive $1.5 million of the funds). This money will allow TSW to double their current enrollment to 60 by next year, eventually growing to 500. Of the 28 students graduating last year, 96% were accepted to college and 74% matriculated, a major achievement when only 34 percent of Philadelphia High School graduates are enrolled in college by the fall (based on 2009 data, the most current numbers available). TSW's expansion to a full 9-12 high school couldn't be more timely, providing more opportunities for students displaced by recent school closings.
While TSW students had their beginnings in automotive engineering, they are not just gearheads. These high school seniors collaborate on a wide variety of projects including disaster relief structures, designing their own future school building, and a vegetable garden. In addition to the $1.5m city award, the students received an exciting $10K challenge to compete against their peers at the John V. Lindsay Wildcat Charter School in the Bronx to see which team could build a superior model for sustainable urban agriculture. Mayors Mayor Michael A. Nutter and Mayor Michael Bloomberg have placed a friendly bet on the outcome. Teams are mentored by teachers and a local farmer with funds from FreshDirect to build a hydroponic garden. Gardens from both schools will be unveiled next month at FreshDirect headquarters in Long Island City, NY on June 11. The hydroponic garden is a great example of project-based learning and sustainability education coming together. Thankfully, more students will have the chance to learn in these dynamic environments.
The Sustainability Workshop students and teachers have come up with a winning program design, and now they will have the resources to support more student-led sustainability projects by a growing student body. We can't wait to see what they do next!
MORGAN BERMAN is the Director of Community Engagement for Grid Magazine as well as a designer of sustainable spaces.


text:
Thomas Hay Marshall (1770 – 15 July 1808) was twice lord provost of Perth, Scotland. With a passion for Georgian architecture, Marshall is credited with building Perth's "new town" to the north and south of the city centre.

Marshall was involved in the founding of Perth Academy, at its former location in Rose Terrace, and in the design of HM Prison Perth.

A bronze statue of Marshall, designed by David Morison and sculpted by John Cochrane and Brothers in 1822, stands behind four Ionic order columns beside Perth Museum and Art Gallery with the Latin phrase cives grati (grateful citizens in English) following his name above the statue.

Marshall Place, which runs along the northern side of the South Inch, is named for him.

Lord provost

Marshall was elected for two terms as Perth's lord provost, serving from 1800 to 1802 and from 1804 to 1806. He was the first to begin serving two-year terms, it previously having been a role that was elected annually.

Military
In 1797, Marshall was initially a captain in the 90th Regiment of Foot, First Battalion, but was promoted to major of the Second Battalion, then lieutenant colonel. In 1798, as a member of the Duke of Wellington's Regiment, he was stationed at Portsmouth Barracks. He served alongside Thomas Black, who was shortly to become lord provost of Perth, and who died in office in the summer of 1798.

Author
Marshall co-wrote The History of Perth: From the Earliest Period to the Present Time, with information added by Henry Adamson. It was published posthumously of Marshall by John Fisher in 1849.

Personal life

Marshall married Rose Anderson on 6 February 1792. The daughter of Thomas Anderson, owner of the Blackfriars land on which Perth is partly built, the Georgian street Rose Terrace, which overlooks Perth's North Inch, is named for her. The couple lived at the corner of Rose Terrace and Atholl Street. Their marriage was brief, Rose having had an affair with Thomas Bruce, 7th Earl of Elgin, and a Dr Harrison. Marshall first "raised letters of inhibition" against his wife on 2 June 1796. They divorced in November 1803, although it took two attempts due to Marshall's providing insufficient evidence of said adultery. Even while he was building his case, the defendant was sleeping with several officers, one of whom testified in court that he had "enjoyment of her person".

The proceedings gave way to several Scots ballads, including "Rosey Anderson":

In 1805, Marshall purchased several properties in Glenalmond from John Murray, 4th Duke of Atholl, for £10,000.

Death
Marshall died on 15 July 1808, aged 38. He lived alone at Bowerswell on the eastern side of the River Tay. He was also in debt, according to several sources. His remains were brought from his home, by his relatives and the Duke of Atholl, to the graveyard of the Church of the Friars Preachers of Blessed Virgin and Saint Dominic at Perth, known locally as Blackfriars.

Legacy
Perth historian Thomas Hay Marshall (1808–1882) was named in Marshall's honour. It is also believed they were related.

References

1770 births
1808 deaths
People from Perth, Scotland
Scottish people
Lord Provosts

redpajama_set_name: RedPajamaWikipedia


text:
IGPA Research Seminar Series
Home / Events / IGPA Research Seminar Series / The Representation of MEM Citizens in Australian Politics and the Decline of Ethnic Voting in Australia
The Representation of MEM Citizens in Australian Politics and the Decline of Ethnic Voting in Australia
Thu 1 December 2016Associate Professor Juliet Pietsch / 4:00pm - 5:00pmThe Dryzek Room (22B13), Building 22, University of Canberra
In terms of Migrant and Ethnic Minority (MEM) representation, the Australian Parliament is one of the most unrepresentative compared to other similar societies such as Canada, the US and New Zealand. This article examines why the Australian parliament is still predominantly comprised of Members of Parliament (MPs) from British and European Backgrounds despite Australia's rich multicultural heritage involving a long history of non-European migration. Among the reasons put forward for the MEM representation gap in Australian politics is that unlike Canada and the US, Australia does not have any national electorates with high levels of racial and ethnic concentration limiting opportunities for mobilisation. A second explanation relates to the fact that ethnic voting in Australia has declined and electoral incentives for parties to recruit ethnic candidates. This seminar paper explores these issues drawing on interviews with Members of Parliament and data from the Australian Bureau of Statistics and the Australian Election Studies to further understand why MEM citizens in Australia are poorly represented in mainstream politics.
Juliet Pietsch is an Associate Professor of Political Science at the Australian National University. Her research focuses on three key areas: a) comparative political behaviour, b) political integration of migrants, and c) racial and ethnic politics. Juliet has been involved in numerous funded research projects, based on the collection and analysis of survey data. Her past projects include the 2010, 2013 and 2016 Australian Election Surveys (funded by the ARC), the World Values Survey, the Australian Survey of Social Attitudes and the ANU Poll. She is currently the Australian coordinator for a comparative research project on the political incorporation of ethnic minorities in Australia and the US. Juliet has a particular interest in understanding the individual, institutional and contextual factors that hinder the social and political inclusion of racial and ethnic minority groups.
Click here to view the flyer
This event is free to attend and no registration is required. You are welcome to forward this invitation to any interested guests.
The IGPA Research Seminar Series is convened by Dr Paul Fawcett.
Back to IGPA Research Seminar Series

redpajama_set_name: RedPajamaCommonCrawl


text:
Post by Ben on Aug 11, 2012 12:04:56 GMT
Good candidate for him.
1918 absent voters register North.
14 Hedwig street
Pte 17657
19th Lancashire fusiliers
CWGC shows
JONES, E
Service No:
Lancashire Fusiliers
19th Bn.
I. B. 14.
CAMBRAI EAST MILITARY CEMETERY
Medal card show same man but have him 1st Nov 1916
SWDGW show him as L/corp
Additional Information: Son of Thomas and Fannie Quick, of "Sunnyside," Yew St., Broughton, Manchester. Of Salford, Lancs.
The 1911 census shows Alfred, a 14 year old school boy, living at 20 Kipling St, Broughton.
From the London Gazette 30/03/1916:
For conspicuous gallantry when in charge of a grenadier section, during an enemy attack when parties of enemy bombers had got into our trench, he bombed out two parties, one after the other with great coolness and courage. Next day he was buried by a trench mortar, but stuck to his post.
He is also remembered on the St Stephen's memorial (sited at St Phillip's).
RICHARD GARSIDE ROBINSON
Regiment/Service: King's Own (Royal Lancaster Regiment) "A" Coy. 8th Bn.
Cemetery KEMMEL CHATEAU MILITARY CEMETERY
Additional Information: Son of Lucy Helen Robinson, of 53, Gt. Cheetham St., West, Lower Broughton, Manchester, and the late James Garside Robinson, of Blackpool. Native of Urmston, Lancs.
Birth Place:	Urmston
Richard was a 16 year old office boy in 1911. He was living at 53 Great Cheetham St, Broughton, with his mother Lucy, and siblings, James, Edith, and John.
JOHN ALBERT ROYLE
Regiment/Service: Queen's Own (Royal West Kent Regiment) 11th Bn.
Additional Information: Son of the late Frederick James and Elizabeth Ann Royle. Native of Higher Broughton, Manchester.
Birth Place:	Salford, Manchester, Lancs
Comments:	Formerly PS/8611, R. Fusiliers
At the age of 20 John, a correspondence clerk, attested on the 30th of August 1915 and was attached to the Royal Fusiliers, Public School Battalion.
Appointed Lance corporal 19/01/16
In hospital (German Measles) 29/05/16 to 12/06/16
Appointed Corporal 17/06/16
In hospital (Bronchitis) 05/07/16 to 12/07/16
Transferred to the West Kent Regiment on the 08/09/1916
JAMES KNEALE SENIOR
Additional Information: Son of the late William and Helena Senior.
Birth Place:	Broughton, Salford Lancs
1911 census - James, a 22 year old insurance clerk, is living at 260 Lower Broughton Rd, Broughton, with parents, William and Helena, and siblings, William, Robert (see below), Marjorie and Esther.
ROBERT MACKENZIE SENIOR
Regiment/Service: Norfolk Regiment 4th Bn. attd. 7th Bn.
Additional Information: Son of the late William and Helena Senior, of 29 Carlton Road, Salford, Manchester.
Robert was originally with the Manchester Regiment (service number 760). Commissioned to the Norfolk Regiment on the 24th of January 1917.
1911 census - Robert, a 19 year old insurance clerk, is living at 260 Lower Broughton Rd, Broughton, with parents, William and Helena, and siblings, William, James (see above), Marjorie and Esther.
FRED SHORROCKS
Residence:	Blackley, Manchester
Death Date:	7 Aug 1915
JAMES ROCKCLIFFE SMITH
Regiment/Service: King's Royal Rifle Corps 16th Bn.
Additional Information: Son of Robert Vanghan Smith and Harriet Elizabeth Smith, of 266, Great Clowes St., Higher Broughton, Manchester.Type of Casualty:	Killed in action
James' Militery Cross and Trio was up for auction in 2005 (unsold).
Please see articles below for more information about James.
HUBERT FRANCIS SMITH
Cemetery WARLINCOURT HALTE BRITISH CEMETERY, SAULTY
Additional Information: Husband of Annie Waite (formerly Smith), of 78, Ashville Terrace, Moston, Manchester.
JAMES HARDY SMITHIES
Service No: S/359660
Regiment/Service: Royal Army Service Corps Claims Commission
Awards: Mentioned in Despatches
Grave Reference LXXII. D. 21.
Cemetery ETAPLES MILITARY CEMETERY
Additional Information: Son of Martha and the late William Henry Smithies; husband of Daisy E. Smithies, of 272, Lower Broughton Rd., Lower Broughton, Manchester.
The 1911 census shows James, an 18 year old clerk, living at 14 Gerald Rd, Broughton, with his parents, William and Martha, and his brothers, William and Frederick.
HAROLD SNELL
Additional Information: Son of William and Sarah Snell, of 6, Woodland Terrace, Higher Broughton, Manchester.
Harold was an 11 school boy and a part time grocer's errand boy in 1911, he was living with his parents, William and Sarah, and brothers, John, Arthur and William, at 6 Woodland Avenue, Broughton.
HARRY BOWKER STOREY
Regiment/Service: Durham Light Infantry 18th Bn.
Grave Reference IV. B. 32.
Cemetery OUTTERSTEENE COMMUNAL CEMETERY EXTENSION, BAILLEUL
Additional Information: Son of Maria Elizabeth Storey, of 17, Hill St., Higher Broughton, Manchester.
Birth Place:	Rio Grandedrene, Brazil
Comments:	Formerly 45779, Lancs Fus.
Harry, aged 18 from 17 Hill St, Broughton, enlisted in the Army on the 17th of October 1917. He was transferred from the Lancashire Fusiliers to the 53rd (Young Soldiers) Durham Light Infantry on the 9th of January 1918, to the 51st DLI on the 5th March 1918 and to the 18th DLI on the 4th of APril, disembarked in France on the 2nd of April 1918 and killed in action on the 19th of July 1918.
The 1911 census shows Harry, a 11 year old schoolboy, living at 6 Murry St, Broughton, with his mother, Maria, and siblings, John, Dora, Majorie, Mabel and Thomas.
ELLIS STOTT
Rank: Carpenter's Crew
Service No: M/5192
Regiment/Service: Royal Navy H.M.S. "Bulwark."
Panel Reference 5.
Memorial PORTSMOUTH NAVAL MEMORIAL
Additional Information: Son of James and Ellen Stott, of 27, Douglas St., Higher Broughton, Manchester.
H.M.S. Bulwark suffered an internal explosion on the 26th of November 1914 off Sheerness killing 736 men.
Ellis was born in Horwich about 1893. He is shown as a 18 year old joiner's apprentice in the 1911 census, living at 27 Douglas St, Broughton, with his parents, James and Eleen, and siblings, Richard, Gertrude and Ethel. Brother of John (see below).
Rank: Able Seaman
Service No: J/9185
Regiment/Service: Royal Navy H.M.S. "Tipperary."
Birth Date:	7 May 1894
Birth Place:	Bolton
Branch of Service:	Royal Navy
Location of Grave:	Not recorded
Name and Address of Cemetery:	Body Not Recovered For Burial
H.M.S. Tipperary was sunk during the Battle of Jutland with the loss of 185 hands.
John was the brother of Ellis (see above). The 1911 census shows him aged 16 serving with the Royal Navy.
GEORGE EDWIN SUTHERLAND
Regiment/Service: Canadian Infantry 3rd Bn.
Panel Reference Memorial VIMY MEMORIAL
Additional Information: Son of William and Jessie Sutherland, of 20, Peru St., Broughton, Salford, Manchester, England.
George was born on the 30th of March 1890. Prior to the war he had worked as an accountant, he attested in to the Canadian Army on the 11th November 1914 aged 24.
The 1911 census shows George, a 21 year old accounts clerk, living at 5 Upper Camp St, Broughton, with his parents, William and Jessie, and brother, Oliver.
GEORGE WILLIAM SYKES
Regiment/Service: Manchester Regiment 21st Bn.
Cemetery BRONFAY FARM MILITARY CEMETERY, BRAY-SUR-SOMME
Additional Information: Son of William Henry and Nellie Sykes, of 344, The Cliff, Higher Broughton, Manchester.
Birth Place:	Failsworth, Lancs
George was a 16 year old clerk in 1911, he was living with his parents, William and Ellen, and siblings, Gertrude, Nellie, Dorothy, Wilfred, Eric and Grace, at 56 Lansdowne Rd, Crumpsall.
WILLIAM TAYLFORTH
Additional Information: Son of William and Marion Taylforth, of Slapestones, Kirkby Lonsdale, Carnforth.
Birth Place:	Kirkby Lonsdale, Westmorland
Residence:	Kirkby Lonsdale
The 1911 census shows William, a 28 year old school teacher, living as a boarder at 5 The Polygon, Broughton with the Valentine family.
The following information was posted by Mack on the Manchesters forum link:
sgt taylforth of B.coy,was killed,during the digging and improvement of trenches,his old friend,sgt valentine of the same company,buried him near the trench and erected a cross,5 other men were also killed,and buried with him,sgts taylforth+valentine (George Hamilton Valentine) both resided at 5.the polygon,broughton
sgt taylforth was the assistant headmaster at st.marks school,cheetham hill,he played rugby for both sale+heaton moor clubs and was a frequent golfer at the heaton park links,he was the holder of the TFEM and been with the battalion for ten years,sgt valentine was wounded shortly after burying his pal,and invalided to malta.
George Hamilton Valentine's brother, Charles, is also remembered on this memorial.
TAYLOR, THOMAS
Additional Information: Brother of Joseph Taylor, of 8, Shawcross St., Langworthy Rd., Seedley, Manchester.
Enlistment Location:	Broughton, Manchester
ALBERT THOMPSON
Additional Information: Husband of Mary Hannah Thompson, of 134, Sussex St., Salford, Manchester.
Residence:	Lower Broughton, Manchester
Cemetery RUYAULCOURT MILITARY CEMETERY
Enlistment Location:	Eccles, Lancs
CHARLES KENNETH VALENTINE
Birth Place:	Moss Side, Manchester
Charles is shown as a 27 year old teacher in the 1911 census, he is living at 5 The Polygon, Broughton, with his parents, William and Annie, siblings, Elizabeth, Gertrude and George, and boarder William Taylforth (see reply 67).
ERNEST JAMES WALKER
Additional Information: Son of Mr. W. J. C. and Alice A. Welsh, of 39, Kipling St., Higher Broughton, Manchester A clerk in Parr's and Westminster Bank, Pendleton, Manchester.
The 1911 census shows Alan, a 12 year old schoolboy, living at 39 Kipling St, Broughton, with his parents, William and Alice, and siblings, Caroline, Alice, William, Edith and Constance.
Alan is also remembered on the Old Salfordians' memorial.
HERBERT WESTCOMBE
Regiment/Service: Manchester Regiment "D" Coy. 21st Bn.
Additional Information: Son of Herbert and Emma Westcombe, of 25, Rowland Rd., Dewsbury Rd., Leeds; husband of Susannah Westcombe, of 6, King St., Higher Broughton, Manchester.
Birth Place:	Leeds
Residence:	Hr. Broughton, Manchester
Herbert is shown as a fish and chip shop proprietor in the 1911 census. He is living at 14 Maleham St, Broughton, with his wife, Susannah, and daughter Edna.
Regiment/Service: Royal Welsh Fusilier 3rd (R) Garrison Bn. transf. to (574269) Base Depot Chinese Labour Corps
Cemetery ABBEVILLE COMMUNAL CEMETERY EXTENSION
Additional Information: Son of Heaton and Ada Mary Whittaker, of Manchester.
Robert was born in Eccles about 1890. He is shown as living at 170 Broughton Lane with his grandmother, mother and sister in the 1901 census.
ARTHUR WIBBERLEY
Cemetery NEUVILLY COMMUNAL CEMETERY EXTENSION
Additional Information: Son of Henry and Alice Wibberley, of Salford; husband of Minnie Wibberley, of 49, Hampshire St., Higher Broughton, Manchester.
Comments:	Formerly 28386, Cameron Highlanders.
Called up for service on the 23/10/16
Posted to the 4th Manchesters on the 25/10/16
To the 2nd Manchesters on the 21/11/16
Transferred to the 1st Garrison Battalion Camerons on the 08/02/17
Transferred back to the Manchesters on the 27/07/17
Disembarked in France on the 21/09/18
Joined the 12th Manchesters (D Coy) on the 26/09/18
Killed in Action on the 12/10/18
The 1911 census shows Arthur, a 24 year old clerk, living at 12 East Market St, Salford, with his mother Alice, and sister Rachel.
JOSEPH CYRIL WILLETT
Regiment/Service: Lancashire Fusiliers 19th Bn. attd. 152nd Coy. Machine Gun Corps (Infantry)
Cemetery ROEUX BRITISH CEMETERY
Additional Information: Son of Joseph and Florence Beatrice Willett, of Cambria House, 246, Great Clowes St., Broughton, Salford, Manchester.
Joseph is shown as a 17 year old insurance clerk in the 1911 census. He is living at 246 Great Clowes St, Broughton, with his parents, Joseph and Florence, and brother Rudolph.
SAMUEL WINTERBOTTOM
Grave Reference I. A. 8.
Cemetery BRONFARM MILITARY CEMETERY, BRAY-SUR-SOMME
Additional Information: Son of Samuel and Sarah Winterbottom, of 22, Wellington St. West, Higher Broughton, Manchester. Native of Salford.
The 1911 census shows Samuel, a 31 year old draughtsman, living at 22 Wellington rd, Broughton, with his parents, Samuel and Sarah, and siblings, Joseph and Sarah.
PERCY WHITE
Additional Information: Son of Mrs. Frances White, of 19, Wordsworth St., Seaford Rd., Manchester.
The 1911 census states that Percy was born in Broughton in about 1893. He is shown as living at 19 Wordsworth St, Pendleton, with his mother.
Regiment/Service: Royal Fusiliers posted to 2nd/2nd Bn. London Regiment (Royal Fusiliers)
Cemetery SAULCOURT CHURCHYARD
Comments:	Formerly 38215, 72Nd T.R. Battn.
Charles and Frank may have been brothers, it is dificult to say for sure as there aren't any ages or parents names to aid in the search. This could be the family living at 33 Fildes St, Broughton, in the 1911 census:
John Wood	41
Sarah Wood	37
Charles Wood	17
Joseph Wood	14
Frank Wood	12
William Wood	9
Ethel Wood	7
Lilly Wood	4
Frances Wood	2
I will try and check when I next visit the Salford History Library.
Last Edit: Dec 30, 2015 16:25:42 GMT by shred
HI Gary, could this be the same John & family ?
1918 absent voters register at 34 Joyson street, Broughton.
John THOMPSON 29320 Sapper R.E.
Joseph THOMPSON 29320 Sapper R.E. ( strange he has the same service & regiment)
1911@ 50 Brighton street, Salford.
William Thompson	41 Head
Elizabeth Thompson	40 Wife
John Thompson	21
Alice Thompson	18
Jane Thompson	15
Ellen Thompson	13
Joseph Thompson	11
Harry Thompson	9
Edward Thompson
1913 directory @ 32 Joyson street, Broughton
William Thompson Fried fish dealer.
I can find a medal card for Joseph with the 29320 number but not a John?
Same regiment and service number is almost certainly a clerical error. This is another one that will have to wait till I visit the library.


[Bug 14187] Typo "chlidren", change to "children"
Next message: bugzilla@jessica.w3.org: "[Bug 14079] WindowProxy open(optional DOMString url, optional DOMString target, optional DOMString features, optional DOMString replace); -- shouldn't the replace argument be boolean?"
Previous message: bugzilla@jessica.w3.org: "[Bug 14189] attribute HTMLElement? body;"
In reply to: bugzilla@jessica.w3.org: "[Bug 14187] New: Typo 'chlidren', change to 'children'"


PART #: JK-00 - NO LONGER AVAILABLE. REPLACE WITH JK-01 OR JK-05.
Description: Black Control Knob (2003).
Description: Black curved Control Knob (2004) (Classic 2005).
Description: Black Plastic Control Knob (2005 Classic Series).
Description: Main Metal Control Knob.
Description: Main Metal Control Knob (2008-09 Classic Series).
Description: Main Metal Control Knob with Chrome Finish (2007-08 Premier).
Description: Black Plastic Control Knob (Elegance Model).
Description: Main JPG Premier Knob with chrome finish.
Description: Main Metal Knob with chrome finish for LUX (up to 2011).
Description: Main JLS Knob made of metal and plastic (late 2012 and newer).
Description: LUX 2013 and newer bezel.
Description: Main JPG Premier Knob (2007). Works with non-flame thrower valve.


text:
Man BRUTALLY stabbed multiple times in his BUTTOCKS and legs
A man walking home was attacked, robbed, and BRUTALLY stabbed in the buttocks and legs. Warning Graphic Images.
by Corné van Zyl
A man walking home was attacked, robbed, and BRUTALLY stabbed in the buttocks and legs.
THE MAN WAS BRUTALLY STABBED MULTIPLE TIMES
Warning this article contains Graphic images.
According to Reaction Unit SA (RUSA spokesperson Prem Balram the attack happened in the early hours of Sunday morning.
"A man was repeatedly stabbed during a robbery shortly after leaving a nightclub in the Verulam CBD in KwaZulu-Natal.
"A passerby contacted Reaction Unit South Africa (RUSA) at approximately 02:04 after the pedestrian was discovered on Garland Street in Temple Valley bleeding from his injuries."
Prem Balram
This Women's Month, we are calling all young female writers to join our exciting Women in Journalism initiative. Find out more here!
Man BRUTALLY stabbed multiple times in his BUTTOCKS and legs Photo: RUSA
THE INJURED MAN WAS FOUND BLEEDING ON THE ROADSIDE
Balram said reaction officers found the man was stabbed multiple times on his legs and buttocks.
"The man explained that he was walking to his Waterloo – KZN residence shortly after leaving a nightclub when three unknown men accosted him.
"The suspects produced knives and robbed him of a Nokia cellphone and R80 in cash. He was stabbed multiple times during the robbery. The robbers fled on foot in an unknown direction, leaving him bleeding on the roadside."
ALSO READ: WARNING: Man shot in legs and buttocks by fleeing robbers
NO ARRESTS HAVE BEEN MADE YET
He said the reaction officers conducted an extensive search for the suspects; however, no arrests were made.
What is it with KwaZulu-Natal and robbers in this province? Earlier this year, a man was shot in both legs and buttocks by fleeing robbers in Vanrova, KwaZulu-Natal.
According to Reaction Unit SA (RUSA) spokesperson Prem Balram, the 27-year-old man was shot multiple times by three suspects who were fleeing the scene of a robbery in Vanrova.
"The Reaction Unit South Africa (RUSA) Tongaat Operations Center received a call for assistance at approximately 19:43 from a resident requesting assistance for the injured man.
"On arrival, RUSA paramedics found the victim bleeding extensively from three gunshot wounds."
ALSO READ: Man dies after being stabbed in chest and buttocks in KZN
Crime in South Africa
Crime, Courts and Justice


text:
Q: React native with firebase (push) notifications So I have registration/login handled on my side using Laravel. I tried adding React-native-firebase so after login I could subscribe to topic like notifications/:userId so I would get notifications only for that user as currently every user is getting push notifications.
I can't find any guide on how to make this so it will work when app is in "dead" state or minimized.
I'd appreciate any help.
Thanks

A: You can use the below mentioned library for firebase integration.
https://rnfirebase.io/

A: Firebase has the Firebase Cloud Messenger, which has some notification control and badges from notifications built into it. I hope that helps, here is a link React-Native (https://rnfirebase.io/docs/v3.1.x/messaging/reference/messaging) and Firebase Docs (https://firebase.google.com/docs/reference/js/firebase.messaging)

A: You have generate fcmtoken after user log in, and save it to database.
After that from server side you have to fetch the fcmtoken for that particular user and call firebase pushnotification api / service.
Notification Payload :
{
  "message":{
    "token":"bk3RNwTe3H0:CI2k_HHwgIpoDKCIZvvDMExUdFQ3P1...",
    "notification":{
      "title":"Portugal vs. Denmark",
      "body":"great match!"
    },
    "data" : {
      "Nick" : "Mario",
      "Room" : "PortugalVSDenmark"
    }
  }
}

If you want to send message/notification to multiple devices minor change is
tokens: ["token1", "token2"]

redpajama_set_name: RedPajamaStackExchange


Nicholas Thomas Wright FRSE (also N. T. Wright or Tom Wright; born 1 December 1948) is an English New Testament scholar, Pauline theologian, and retired Anglican bishop. Between 2003 and 2010, he was the Bishop of Durham. He then became Research Professor of New Testament and Early Christianity at St Mary's College in the University of St Andrews in Scotland.


text:
Q: number of employees on hr.employee on odoo I want to have the number of employees in odoo who are active, in other words the number of employees who are in the hr.employee list view, this function return me nbr-employee = 0, since 4 days i cant resolve it.
class Employee(models.Model):
    _inherit = 'hr.employee'

    nbr_employee = fields.Integer(compute="_get_count_employee", store='True')

    @api.one
    def _get_count_employee(self):
        for t in self:
            t.nbr_employee = t.env['hr.employee'].sudo().search_count([('active', '=', True)])

 <field name="inherit_id" ref="hr.view_employee_form"/>
            <field name="arch" type="xml">
                <xpath expr="/form/sheet/notebook" position="inside">
                    <page string="Indicateurs de performance de recrutement">
                                   <group>
                                       <field name="nbr_employee" string="nbr_employee:"/>
                                    </group>
                    </page>
                </xpath>
            </field>

A: Hinda ABASSI
You have store the field but on the computation not use the field which depends to perform the calculation.
nbr_employee = fields.Integer(compute="_get_count_employee")

@api.multi
def _get_count_employee(self):
    for emp in self:
        emp.nbr_employee = self.env['hr.employee'].search_count([('active', '=', True)])

Also on the Fields declaration, you did a mistake use store=True.


text:
Regulator Performance Framework
The Australian Government has developed a framework to measure the performance of regulators. The Regulator Performance Framework (the Framework) comprises six outcomes-based key performance indicators (KPIs) as listed below to articulate the Government's overarching expectations of regulator performance:
Regulators do not unnecessarily impede the efficient operation of regulated entities
Communication with regulated entities is clear, targeted and effective
Actions undertaken by regulators are proportionate to the regulatory risk being managed
Compliance and monitoring approaches are streamlined and coordinated
Regulators are open and transparent in their dealings with regulated entities
Regulators actively contribute to the continuous improvement of regulatory frameworks.
These KPIs are supported by measures of good regulatory performance to assist regulators in assessing their achievement of the KPIs.
The Framework aims to encourage regulators to undertake their functions with the minimum impact necessary to achieve regulatory objectives and to effect positive ongoing and lasting change within regulators. The Framework will allow regulators to report objectively on the outcomes of their efforts to administer regulation fairly, effectively and efficiently.
The Framework has applied since 1 July 2015, with the first assessment period being the 2015-16 financial year. Our reports will be published annually on the Therapeutic Goods Administration (TGA) website. Further information on the Government's Framework is available at: Regulator Performance Framework.
On this page: Assessing our achievement of the KPIs | Summary of our performance in 2015-16 | Additional reporting
Assessing our achievement of the KPIs
In consultation with our stakeholders through the TGA Industry Consultative Committee (TICC) and the Australian Therapeutic Goods Advisory Council, an agreed set of TGA specific qualitative and quantitative outputs and evidence against the Government's KPIs were developed to assess our achievement. These KPIs were endorsed by the then Assistant Minister and published on our website in June 2015. The evidence metrics are specified under each of the KPIs and form the basis of our self-assessment.
In preparing our self-assessment against the KPIs multiple data sources were utilised, including:
published advice on our website
business improvement activities
international and domestic stakeholder forums.
Our self-assessment was externally validated in September 2016 by the TICC, which comprises industry and consumer representatives.
General feedback from TICC members was positive, supporting our self-assessment overall and agreeing there is sufficient evidence to support our performance ratings for KPIs 2 to 6. In relation to KPI 1, some members suggested that a performance rating of substantially met would be more appropriate, as the evidence did not adequately demonstrate the performance rating of met.
Members noted their appreciation of our efforts in stakeholder engagement, communication and ongoing business improvements.
In terms of feedback on whether the self-assessment process provided sufficient, reliable and current evidence to support our overall performance rating of met, TICC members either agreed or somewhat agreed. Members noted that this is the first report of its kind, and although the majority of the evidence matrices are appropriate and an effective tool for assessing our compliance against the KPIs, the matrices should be subject to continuous improvement to ensure relevance.
Summary of our performance in 2015-16
Self-assessed rating of overall performance
Overall we met the requirements of the Framework through meeting KPIs 1, 3, 5 and 6 with 'strong performance' against these measures and through substantially meeting KPIs 2 and 4. A brief summary is provided blow.
Self-assessment rating and summary of overall performance
KPI 1. Regulators do not unnecessarily impede the efficient operation of regulated entities Met
The performance rating of met is supported by successful participation in formal stakeholder forums and participation at industry events. This has led to smaller face-to-face workshops and increased opportunities for our staff to improve their knowledge of emerging technologies and provide industry with an opportunity to increase understanding of our regulatory requirements.
Additionally, we have implemented a number of initiatives under the Business Improvement Program aimed at reducing compliance costs to industry.
KPI 2. Communication with regulated entities is clear, targeted and effective Substantially met The performance rating of substantially met is based on medical device timeframes for application audits not being met, although these timeframes are not mandated in legislation. The legally-mandated timeframes for medical device conformity assessment were met in 100% of cases.
KPI 3. Actions undertaken by regulators are proportionate to the regulatory risk being managed Met
The performance rating of met is supported by our risk management approach in regulating therapeutic products, including identifying entities at risk of unintentional or deliberate non-compliance, and the collection of intelligence in relation to alleged breaches of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.
Evidence of actions undertaken by regulators that are proportionate to the regulatory risk is also outlined in our laboratories targeted testing of medicines and medical devices according to the risk they pose to the public, monitoring of the market for signals of potential non-compliance and the scheduling of manufacture inspections based on compliance records.
Additionally, we can communicate regulatory requirements and compliance expectations quickly and directly to market-entry applicants.
KPI 4. Compliance and monitoring approaches are streamlined and coordinated Substantially met The performance rating of substantially met is because we do not yet have a fully mature compliance and enforcement framework with graduated sanctions and penalties. While we have a sound compliance structure in place, we do not yet have a range of regulatory tools which allow us to use the full range of compliance approaches.
KPI 5. Regulators are open and transparent in their dealings with regulated entities Met
The performance rating of met is demonstrated through our continued efforts towards raising awareness of our regulatory framework through industry workshops and the publication of educational material, as well as maintaining telephone and email based information lines.
We also publish regular performance activity reports on our website.
KPI 6. Regulators actively contribute to the continuous improvement of regulatory frameworks Met The performance rating of met is supported by our stakeholder engagement through market research, continued business improvements and interactions with other regulators.
Additional reporting
The reporting provided through these KPIs focuses on our performance as a regulator and our engagement with our stakeholders, however we will continue to produce other reports with more detailed information about our regulatory and corporate activities. These reports include the:
annual Performance Statistics Report
annual TGA Business Plan
Half Yearly Performance Report Snapshot - July to December 2015
Department of Health Annual Report
Health Portfolio Budget Statements 2015-16.
These reports are publicly available and can be read in conjunction with the KPIs.
On this page: KPI 1.1 Regulators demonstrate an understanding of the operating environment of the industry or organisation, or the circumstances of individuals and the current and emerging issues that affect the sector. | KPI 1.2 Regulators take actions to minimise the potential for unintended negative impacts of regulatory activities on regulated entities or affected supplier industries and supply chains. | KPI 1.3 Regulators implement continuous improvement strategies to reduce the costs of compliance for those they regulate.
KPI 1.1 Regulators demonstrate an understanding of the operating environment of the industry or organisation, or the circumstances of individuals and the current and emerging issues that affect the sector.
1.1a Number of TGA participations in industry formal stakeholder forums, including meetings and working groups and feedback received on TGA presentations.
Within the reporting period we participated in 81 formal stakeholder forums that included attendance and participation at industry events, hosting regulator workshops for stakeholders, staff speaking engagements and bilateral meetings with industry groups.
Examples of these interactions included:
four stakeholder workshops in Sydney, Melbourne and Canberra in October and November 2015 to consult on communication strategies for implementing changes to medicine ingredient names. The workshops were attended by representatives from the pharmaceutical and medical software industries as well as by health professionals, consumers and other relevant government agencies
bilateral meetings with nine peak industry bodies to discuss key policy issues, the fees and charges proposal for 2016-17, as well as several other subject specific meetings with each body
in cooperation with medical device peak bodies, an information day for medical device sponsors in Canberra on 15 October 2015. Nearly 200 people from the medical device industry attended the event, which provided information on the regulatory life cycle for medical devices. Industry feedback indicated this was successful, and there has been significant traffic for the presentations posted on our website following the event (9,724 viewings)
in cooperation with the Australian Self Medication Industry, presentations at multiple training seminars for advertisers designed to improve awareness and understanding of the legislative requirements that apply to the advertising of therapeutic goods
regular working groups with industry (e.g. Regulatory Affairs Working Group with Medicines Australia and the Generic and Biosimilar Medicines Association - 9 October 2015 and 6 April 2016) to discuss inter alia the predictability and timeliness of the prescription medicine registration process through the provision and discussion of performance data
participation in meetings with stakeholders in August 2015 (prescription medicines and medical devices) and December 2015 (complementary medicines and advertising) to explore industry priorities and issues relating to the Expert Panel Review of Medicines and Medical Devices Regulation.
Feedback from these interactions, including the above educational seminars and events, has resulted in other smaller face-to-face workshops, as well as increased participation in online education webinars.
1.1b Information on informal interactions with industry and how they are able to build understanding, for example ad hoc meetings between senior TGA staff and industry on specific issues and educational seminars for TGA staff on industry business activities.
We regularly engage with industry to provide guidance on a range of regulatory matters. During the period, these interactions included:
convening discussions and providing support to sponsors on potential safety and performance issues
working cooperatively with industry stakeholders by:
providing direction on actions required for the finalisation of transition for joint replacement medical devices from class IIb to class III medical devices
hosting informal meetings to discuss changes to the prescription medicines registration process. Discussions included shortening the pre-submission timeframes and minimising data requirements
holding workshops in Sydney, Melbourne and Brisbane between November 2015 and February 2016 to inform stakeholders on the introduction of a new online submission system for Clinical Trial Notifications (CTNs)
providing updates to laboratory stakeholders on the transition period for in-house in vitro diagnostic medical devices (IVDs) and advice on how to comply with regulatory requirements
undertaking user testing of the web-based interfaces for the Special Access Scheme and Adverse Event Management System
conducting Australian Public Assessment Reports (AusPARs), pre-submission pilot, and TGA Stakeholder 2015-16 surveys.
During these interactions our staff had the opportunity to improve their knowledge of emerging technologies, innovative products and priorities for the regulated industry. These activities also provided industry with an opportunity to increase its understanding of our regulatory requirements.
KPI 1.2 Regulators take actions to minimise the potential for unintended negative impacts of regulatory activities on regulated entities or affected supplier industries and supply chains.
1.2a Evidence of continued compliance with our practice of engagement with industry before a regulation impact statement (RIS) is finalised, to minimise the potential for unintended impacts on regulated entities and product supply.
We engaged with industry stakeholders prior to finalising RISs relating to the International Harmonisation of Medicine Ingredient Names and the Annual Charge Exemption Scheme, along with two sunsetting regulatory instruments that were remade with no changes. For more information see KPI 6.2a. This ensured that any unintended negative impacts were minimised.
KPI 1.3 Regulators implement continuous improvement strategies to reduce the costs of compliance for those they regulate.
1.3a Progress towards implementation of the Australian Government Digital Transition Policy.
Digital record keeping means that the majority of an agency's records will be created, stored and managed digitally and, where possible, incoming paper records will be scanned so that new paper files are not created.
Over the period, 75% of submissions for medicines, devices and biologicals were provided in electronic format. This figure has increased from 72% in June 2015.
A number of initiatives assisted in our transition to digital processes such as:
the cessation of paper files project which will cease the production of paper-based files
commencement of the pilot for an internationally standardised structure for conformity assessments for medical devices, known as the Table of Contents pilot
coinciding with the implementation of electronic Common Technical Document (eCTD), we mandated requirements for industry to cease the production of physical data. This improved the quality of the e-submissions and validation process, and helped to streamline the assessment process
other business improvement projects e.g. electronic form for minor variations to prescription medicines.
1.3b Progress of the strategies being implemented under the business improvement program and other specific projects aimed at reducing compliance costs for industry.
We have implemented a number of initiatives aimed at reducing compliance costs for industry. We launched the TGA Business Services website (enabling the regulated industry to view and pay invoices, maintain contact details, check the status of applications and respond to requests for additional information) and implemented paperless processes for three quarters of product billing and industry assistance functions (e.g. invoice requests, request for credit notes, write-off approvals).
Further initiatives included:
we commenced receiving and managing eCTD submissions in addition to non-eCTD electronic submissions for prescription medicine applications. 100% of Category 1 applications (to register a new prescription medicine, other than an additional trade name, or make a variation to an existing medicine), were received electronically. The submission of hard copy dossiers for Category 1 applications is no longer required, resulting in significant savings for industry and the Department in avoided printing and storage costs
a new corporate Ingredients Repository - a centralised source of ingredient and proprietary ingredient information, referenced by most systems at the TGA. In addition to being easier to maintain (through the auto-population of client details from a validated source), the new Ingredients Repository will improve the Ingredient Summary documents available via our eBusiness Services (eBS) public portal and reduce enquiries from industry stakeholders seeking clarification or additional information
the ability to more easily develop smartforms through the acquisition and implementation of an eForm development tool
the commencement of a new adverse event management system which, when completed, will improve processes and reporting
the new Annual Charges Exemption (ACE) scheme, which has replaced and improved the previous low value turnover (LVT) scheme to exempt goods from annual charges on the basis of low sales turnover, took effect from 1 July 2015
a pre-submission pilot pathway for prescription medicine applications was introduced in February 2016. The pilot aims to reduce the regulatory burden on industry by removing the need to provide summary information prior to lodgement of a submission for new prescription medicines
development of policy and implementation design activities ahead of public release of the Government's response to the recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation.
On this page: KPI 2.1 Regulators provide guidance and information that is up to date, clear, accessible and concise through media appropriate to the target audience. | KPI 2.2 Regulators consider the impact on regulated entities and engage with industry groups and representatives of the affected stakeholders before changing policies, practices or service standards. | KPI 2.3 Regulators' decisions and advice are provided in a timely manner, clearly articulating expectations and the underlying reasons for decisions. | KPI 2.4 Regulators' advice is consistent and supports predictable outcomes.
KPI 2.1 Regulators provide guidance and information that is up to date, clear, accessible and concise through media appropriate to the target audience.
2.1a Percentage of pages on the TGA website that comply with the Australian Government accessibility requirements.
We have an ongoing program of developing, reviewing and updating regulatory and technical guidance material to comply with Australian Government requirements and international standards for web content accessibility.
Web Content Accessibility Guidelines (WCAG) requirements include the need for the content to be findable, scannable, readable and accessible. A systematic approach to maintaining content is also required. To meet these requirements we have created a new standard database model through which data can be easily discovered, navigated and disseminated.
90% of TGA information on our website is WCAG2.0 compliant. The remaining content includes a large number of third party documents, for example consultation submissions, Product Information (PI) and Consumer Medicine Information (CMI) documents.
We actively monitor and review material on the website to ensure it meets WCAG2.0 compliance requirements, and is user-focused.
We have also delivered a completely new website search platform to improve access to content on the website.
2.1b Improvements made to guidance documents, forms, and information on the TGA website
Guidance material is intended to lend further clarity to the regulatory processes, to assist industry and other stakeholders to understand and comply with our requirements. We continually develop and update regulatory and technical guidance material. This includes simplified navigation of our website pages.
During the reporting period, we published a range of new and updated guidance documents and material, including:
an evaluation plan estimator for applicants who lodge applications for prescription medicine registrations. This provides estimated dates for the milestones in the registration process to aid in planning applications and was viewed 3,725 times in the reporting period
prescription medicine guidance, such as Common Technical Document (CTD) Module 1, general dossier requirements, extensions of indications, additional trade names, non-eCTD electronic submissions, preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines
updated guidance for sponsors on evidence of Good Manufacturing Practice (GMP) compliance for prescription medicines
revised guidance for applicants lodging prescription medicine registration applications to include information on the pre-submission pilot registration pathway, such as questions and answers and a fact sheet to aid planning
information about changes to medicine ingredient names to align with names used internationally, including to ten pharmaceutical industry organisations, seven medications software/information industry organisations, four consumer organisations and eight government organisations.
guidance on regulatory requirements for in vitro diagnostic medical devices (IVDs)
revised guidance on the reduction of assessment fees for conformity assessments of medical devices (including IVDs), providing industry with greater clarity on the assessment fees that may apply
revised forms to make it easier to collect information from sponsors, including consultation submissions, electronic forms to notify medicine shortages and online forms for clinical trial notifications and custom made medical devices.
a major revision of the Australian regulatory guidelines for over the counter (OTC) medicines and the TGA approved terminology for medicines, including guides on registration and change processes, CTD Module 1 for OTC medicines, mandatory requirements for effective OTC medicine applications, technical guidance, flowcharts and tools for sponsors
an application form for sponsors to use when applying for permission to export therapeutic goods for clinical trials.
2.1c Number of educational materials and other documents developed or updated for stakeholders (industry, consumers, health professionals). Number of downloads of these from the website and social media, and data on user satisfaction where available.
We created various educational materials for consumers, health professionals and industry during the reporting period, including:
two instructional and training videos: a user guide to the new TGA Business Services for industry; and information for consumers about buying medicines online
26 presentations for various industry events and 10 presentations for the Devices Sponsor Information Day, providing an overview of the regulatory life cycle for medical devices
a series of educational materials to raise awareness about upcoming changes to medicine ingredient names.
Additionally, there were 13 fact sheets and frequently asked question (FAQ) documents including:
Cannabis re-scheduling proposal - questions and answers Updating medicine ingredient names Cosmetic injections: beware of 'home based' beauty services
Advertising health services with medical devices Advertising health services with Schedule 3, Schedule 4 or Schedule 8 medicines Stem cell treatments and regulation - a quick guide for consumers
Updating medicine ingredient names Advertising of vaccination services Weight loss: beware of buying unregulated products online
Annual charges exemption scheme - questions and answers Can I import it?
Custom made medical devices
FAQs on Clinical Trial Notification online submissions and the clinical trials scheme
Significant downloaded or viewed materials for 2015-16 for each stakeholder group are highlighted below.
Consumer & Health professional content: downloads and views through various TGA media channels for the period July 2015 to June 2016
Name of material[1]
New or updated
Publication medium
Number of views/downloads
Updating medicine ingredient names New Posters & website TGA website & direct email
18,525 views (Website)
Cosmetic injections: beware of 'home based' beauty services New News item TGA website 1,132 views
Stem cell treatments and regulation - a quick guide for consumers New Questions and Answers TGA website 704 views
Managing the Challenges and Opportunities of Breakthrough Therapies New Presentation SlideShare 434 views
Buying medicines and medical devices online New Video & webpage YouTube, TGA website 225 views (launched on 26 June 2016)
Industry content: downloads and views through various TGA media channels for the period July 2015 to June 2016
Name of material*
TGA and industry presentations - Devices Sponsor Information Day 15 October 2015 New 12 presentations SlideShare, TGA website 9,724 views
The new TGA Business Services site Updated Video YouTube, TGA website 1,056 views
Evidence of GMP compliance for prescription medicines Updated Webpage TGA website 2,677 views
Half Yearly Performance Report Snapshot (July to December 2015) and the interactive online summary New Report TGA website 1,227 (between May and June 2016)
The information reported in the above two tables focuses on materials either developed or updated during the reporting period. However, additional materials are made available to stakeholders via the TGA website and social media channels.
These materials can be accessed by stakeholders using various media channels including our website, the TGA Australia YouTube channel and SlideShare.
Education and awareness raising activities were also conducted to support adverse event reporting by consumers and health professionals and improved reporting interfaces were implemented.
KPI 2.2 Regulators consider the impact on regulated entities and engage with industry groups and representatives of the affected stakeholders before changing policies, practices or service standards.
2.2a Details of formal consultations completed during the reporting period, including evidence that the TGA has closely considered submissions from stakeholders.
Some of the activities consulted on during the period included changes to regulatory practices or requirements, reviews of business processes, reviews of standards or guidelines, and fees and charges. For each consultation an internal report is prepared which outlines how submissions have been considered and what action has been taken in response. This forms the basis for our response which is published on our website.
Examples of completed consultations during the reporting period include:
draft guidelines outlining our expectations for clinical evaluation reports and underlying evidence to be held by medical device manufacturers as part of their conformity assessment procedures
proposed amendments to the Poisons Standard
proposed adoption of specific European Union (EU) guidelines in Australia for medicines
proposal for adoption of Pharmaceutical Inspections Convention Scheme/Pharmaceutical Inspections Cooperation Scheme (PICs) - GMP standards and revisions and improved consultation process on the adoption of PIC/s guidelines
updates to medicine advisory statements.
During the reporting period 14 formal consultations were completed. We aim to publish consultation submissions and our response on our website within two weeks following consultation with the Minister.
2.2b Evidence of discussions with affected stakeholders before TGA processes are changed.
In addition to the formal consultation process, we engaged with sponsors and key industry groups that may have been affected by planned changes to regulatory or business processes.
Some examples of topics discussed with affected stakeholders include:
development and implementation of changes to the prescription medicines process, specifically the pre-submission pilot for new chemical entities and new generic medicines
introduction of requirements for medicine label advisory statements
introduction of a revised fee structure for OTC medicine applications
updates to the Australian Regulatory Guidelines for OTC Medicines, including changes to mandatory requirements and a reduction of target times for processing applications that comply with an OTC medicine monograph
introduction of a legislative instrument with a single list that specifies the ingredients available for use in listed medicines.
KPI 2.3 Regulators' decisions and advice are provided in a timely manner, clearly articulating expectations and the underlying reasons for decisions.
2.3a Information for consumers, health professionals and industry on the basis for the TGA's decision making, including any work to improve the quality of our decision making.
Information on pre market and post-market regulatory decisions detailing the basis for the decision are published on our website, including:
ARTG entries: a publicly available online database of information about approved therapeutic goods that can be supplied in Australia, as well as those that have been suspended or cancelled
AusPARs: information about the evaluation of a prescription medicine and the considerations that led us to a decision
a list of Australian medicines manufacturers that have been issued with a GMP (manufacturing) licence
the System for Australian Recall Actions: an online, searchable database containing information about recall actions for therapeutic goods
outcomes of investigations into complaints about advertising
outcomes of court actions relating to therapeutic goods.
During the reporting period, improvements to the quality of our decision making were implemented, including:
updated decision letter templates to provide more consistent information to applicants regarding the legal provisions available to sponsors to review our decisions
a program to seek ongoing feedback and provide training to internal review delegates.
A public subscription service is available and provides for automatic email notification of updates to the ARTG, safety-related alerts, revised guidelines, medicine shortages alerts, and other notices.
2.3b Percentage of pre-market applications and post-market activities processed in target timeframes.
Applications for market authorisation of therapeutic goods are processed with reference to target timeframes. There are different targets in place for the time taken to make a regulatory decision, depending on the type of therapeutic good being considered. Some of these targets are specified in the legislation. Timeframes exclude 'hold times' where we are waiting for a response from an applicant following a request for information, and include any time for committee consideration.
During the reporting period, the percentage of pre market applications processed within their respective timeframes were:
100% of prescription medicine applications (new chemical entity, fixed dose combinations, extension of indications and generic medicines)
99% of new over-the-counter medicine applications
100% of medical device conformity assessment applications
100% of medical device (including IVD) inclusion applications not selected for audit
medical devices (not-IVD) - 66% of non-compulsory audits, 67% of Level 1 compulsory audits and 15% of Level 2 compulsory audits
IVD medical devices - 53% of non-compulsory audits and 72% of compulsory audits (mTFR).
In relation to post-market activities, 100% of medical device incident reports were processed within target timeframes.
2.3c Publication of information for health professionals, consumers and industry when medicines are registered and/or new information arises on therapeutic goods.
We regularly issue news updates, tweets and public notices for consumers, health professionals, industry and the community. Some of the publications issued during the reporting period included:
six editions each of the Medicines Safety Update and the Medical Devices Safety Update, providing health professionals with practical information about safety issues
109 web statements regarding safety alerts, shortages, reviews, early warnings or recalls affecting prescription medicines or medical devices.
In the TGA Stakeholder Survey 2015-16, overall reaction to education and publication activities was positive. Standout satisfaction ratings were achieved for the TGA update and TGA guidelines with 95.1% and 94.8% of users rating them useful to extremely useful in their roles respectively.
In November 2015 we launched the TGA Twitter channel to improve our information sharing on social media.
Some specific examples of information published on our website include:
new prescription medicines and new or extended indications to currently registered products (including a subscription alert)
AusPARs: reports include information about the evaluation of a prescription medicine and the consideration that led us to a decision
CMI and PI documents for registered medicines (including any updates)
a list of new or extended uses or new combinations of registered prescription medicines which is updated monthly
Quantity of information by type published on the TGA website for the period July 2015 to June 2016.
Australian public assessment reports (AusPARs) 74
Expert advisory committee meeting statements 19
Scheduling advisory committee interim and final decisions 15
New Chemical Entities (NCE) approvals 35
Extension of Indications (EOI) approvals[1] 18
Web statements: recalls/medicines safety alerts/suspensions
Medicines - 68
Medical devices - 36
Medicines Safety Updates 6
Medical Devices Safety Updates 6
Early warnings - potential safety issues 3
Medicine shortage web statements 4
1 The publication of new or extended uses for prescription medicines commenced in January 2016.
KPI 2.4 Regulators' advice is consistent and supports predictable outcomes.
2.4a Percentage of substantive regulatory decisions subject to internal review, for which the original decision is revoked and substituted, without consideration of additional information.
Internal reviews are undertaken when a person whose interests are affected by an initial decision requests reconsideration of the decision by the Minister under section 60 of the Therapeutic Goods Act 1989.
The decision maker reviewing an initial decision may confirm the initial decision, revoke the initial decision or revoke the initial decision and substitute a different decision.
We make more than 34,000 regulatory decisions every year. During the reporting period, we made decisions on 19 applications for internal review of regulatory decisions. Of these, five initial decisions (26%) were revoked, or revoked and substituted. However, in all five cases, additional information was made available to the internal review delegates that was not submitted at the time of the original application.
2.4b Outcomes of matters referred by sponsors to the Administrative Appeals Tribunal (AAT), including where TGA decisions are upheld, and where the outcome is indicative of an issue about the quality of the decision.
During the reporting period nine matters were referred to the AAT and four of these matters were completed. Of these four, three applicants withdrew their application for a review. In the fourth case the applicant came to an agreement with us about the issues that were before the AAT, based on additional information that was obtained by the applicant after the appeal was lodged to the AAT. Both parties applied for, and were granted, consent orders to reflect the terms of that agreement.
For those matters that have been finalised, none of the outcomes of the AAT review were indicative of an issue about the quality of the initial or reviewable decisions made by us.
The performance rating of "substantially" met is based on medical device timeframes not being met.
Strong performance against most of the measures under the KPI
Poor performance against all of the measures under the KPI
On this page: KPI 3.1 Regulators apply a risk-based, proportionate approach to compliance obligations, engagement and regulatory enforcement actions. | KPI 3.2 Regulators' preferred approach to regulatory risk is regularly reassessed. Strategies, activities and enforcement actions are amended to reflect changing priorities that result from new and evolving regulatory threats, without diminishing regulatory certainty or impact. | KPI 3.3 Regulators recognise the compliance record of regulated entities, including using earned autonomy where this is appropriate. All available and relevant data on compliance, including evidence of relevant external verification is considered.
KPI 3.1 Regulators apply a risk-based, proportionate approach to compliance obligations, engagement and regulatory enforcement actions.
3.1a Outcomes of completed investigations of alleged offences.
There were no enforceable undertakings entered into during the period.
One matter was referred to the Commonwealth Director of Public Prosecutions (CDPP) for assessment. One court outcome was finalised and published on our website along with the outcomes of other compliance actions.
Of 1,760 completed investigations, 946 warnings were issued and one matter was referred to the CDPP.
Of 2,526 products investigated, prescription medicines comprised 71%, complementary medicines 18%, OTC medicines 1.8%, biologicals 1.9% and medical devices 3.9%.
3.1b Publication of evidence of compliance activities to support the continued availability of safe, effective and high quality therapeutic goods for the Australian public.
We use a staged risk management approach to compliance that attempts to identify entities at risk of unintentional or deliberate non-compliance and collect intelligence in relation to alleged breaches of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.
Our Laboratories Branch undertakes targeted testing of medicines and devices according to the risk they pose to the public. The outcomes of samples and products tested by type of therapeutic good and the percentage which failed is reported in the TGA Performance Statistics Report, which is published on our website. Excluding samples tested for accreditation, harmonisation and quality control, 1,696 samples of 761 products were tested. There was a failure rate of 26%, with 30% of medical devices failing, 0.5% of prescription medicines, 19% of OTC medicines and 20% of complementary medicines failing. 76% of unregistered products failed, these often being adulterated complementary medicines or counterfeit products.
We publish details of listed medicines cancelled from the ARTG following compliance reviews, including the provisions under which the cancellation was undertaken. We also publish details of cancellations and suspensions of medical devices (including IVDs).
Additionally, we publish statistics on the proportion of outcomes of inspections in terms of manufacturer performance (satisfactory, marginal and unacceptable) and the timeliness of inspections conducted within prescribed timeframes. Detailed information can be found in our Performance Statistics Report which is published on our website.
KPI 3.2 Regulators' preferred approach to regulatory risk is regularly reassessed. Strategies, activities and enforcement actions are amended to reflect changing priorities that result from new and evolving regulatory threats, without diminishing regulatory certainty or impact.
3.2a Information on the TGA's risk framework published on the TGA website, and regularly kept up-to-date.
The Therapeutic Goods Act 1989 underpins our work and outlines a risk-based regulatory framework for therapeutic goods.
Some examples of documents describing this include:
TGA Regulatory Framework - outlines how we regulate according to risk
TGA Regulatory Compliance Framework.
During the reporting period, advice was provided to the Government in response to the recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation, and a budget measure was published in the May 2016 Budget. Work is currently underway to review and strengthen our regulatory framework and assessment of risk in response to the Review.
3.2b Information on activities undertaken to ensure that a risk-based approach is taken to prioritise complaints and other signals of possible non-compliance with regulatory requirements.
The Regulatory Compliance Committee monitors our compliance actions and practices. Complaints and other signals of possible non-compliance are prioritised for investigation and potential regulatory action based on the level of risk posed. Factors influencing priority include consumer safety and the risk or nature of the regulatory breach. Priority is based on factors that:
could significantly mislead the Australian public, particularly where there is a health impact
are likely to become widespread if we do not intervene
are of national or international significance
involve a new or emerging issue of concern
are the subject of public scrutiny and concern
could lead to a loss of stakeholder confidence in us or therapeutic goods.
For investigations that identify a potential safety or quality risk, testing of samples may be required. The results of testing determine if further action is required, such as a risk assessment, cancellation and/or recall. Appropriate enforcement actions (and appropriate follow-up) are implemented based on the risk assessment and investigation of post-market issues.
For safety reviews, a risk-based process has been developed for the screening and prioritisation of signal investigations. This process provides a rationale for allocation of resources and ensures we can respond to emergent safety issues. All identified issues are recorded and acted upon within a timeframe appropriate to their impact on public health. If a safety concern relating to a medicine or vaccine is identified, a range of regulatory action may be taken.
KPI 3.3 Regulators recognise the compliance record of regulated entities, including using earned autonomy where this is appropriate. All available and relevant data on compliance, including evidence of relevant external verification is considered.
3.3a Information on activities undertaken to ensure that a risk-based approach is taken to monitoring and compliance activities.
Proportionate compliance activities
We monitor the market for signals of potential non-compliance across the range of regulatory areas covered by the Therapeutic Goods Act 1989 and employ a uniform risk-based approach to determining the significance of any signals detected and the appropriate regulatory response.
We can communicate regulatory requirements and compliance expectations quickly and directly to a market-entry applicant and can deny market access to applicants who cannot demonstrate compliance with these requirements. Providing regulatory education to applicants at or before this point can help to minimise non-compliance once a product is marketed.
Scheduling of inspections based on compliance records
We employ risk-based inspection frequency matrices to guide the frequency of inspections. Manufacturer performance at inspection is categorised as satisfactory, marginal and unacceptable with further granularity provided by applying a high, medium or low risk rating. These ratings are applied when setting the date for reinspection. The matrix also takes into account product and process risks.
Before scheduling inspections, we consider emerging trends, recalls, adverse events, results of laboratory testing, feedback and inspections undertaken by other regulators and manufacturer profiles that have been updated to reflect any significant changes with the company.
Targeted complementary medicine reviews are based in part on the compliance record of the particular sponsor.
During the reporting period, the focus was on raising compliance levels of Australian manufacturers.
Product Safety monitoring
All post-market safety-related activities are undertaken using a risk-based approach under our therapeutic product vigilance framework. There were 37 products with a Risk Management Plan (RMP) identified as being a high priority for periodic safety update review, equalling one-third of products approved with an RMP evaluation. The majority of RMP evaluations were conducted for new chemical or biological entities, and applications to extend the indications of registered products.
We use a risk-based approach to determine the classification and level to which a recall is undertaken (consumer level, retail level, hospital level or wholesale level) by considering the significance of the hazard, the channels by which the goods have been distributed, and the level to which distribution has taken place.
All recalls are risk assessed and classified into Class I, II and III which aids in the prioritising of actions. Class I and Class II actions are safety related with highest priority given to Class I issues which can result in serious injury or death to patients or users. Class II issues could cause illness, injury or result in mistreatment, but are not Class I. Class III actions occur when issues may not pose a significant hazard to health, but action may be initiated for other reasons e.g. quality related issues.
Out of the 667 recalls for medicines and medical devices undertaken during the reporting period, 130 were Class I, 463 were Class II and 74 were Class III.
Where we receive a complaint regarding advertising it is triaged and prioritised based on the risks that the advertising could pose, primarily to public health and safety, but also our compliance activities and regulatory responsibilities.
During the reporting period, we received 312 complaints about the advertising of therapeutic goods. Where evidence of non-compliance with the legislative requirements is identified, the matter is addressed in the context of our Regulatory Compliance Framework.
Strong performance against most of measures under the KPI Poor Performance against all of the measures under the KPI
On this page: KPI 4.1 Regulators' information requests are tailored and only made when necessary to secure regulatory objectives, and only then in a way that minimises impact. | KPI 4.2 Regulators' frequency of information collection is minimised and coordinated with similar processes including those of other regulators so that, as far as possible, information is only requested once. | KPI 4.3 Regulators utilise existing information to limit the reliance on requests from regulated entities and share the information among other regulators, where possible. | KPI 4.4 Regulators base monitoring and inspection approaches on risk and, where possible, take into account the circumstance and operational needs of the regulated entity.
KPI 4.1 Regulators' information requests are tailored and only made when necessary to secure regulatory objectives, and only then in a way that minimises impact.
4.1a Information on activities undertaken to minimise the need for, or number of, requests for information to sponsors under the relevant legislation.
We continually implement processes to minimise the number of formal requests for information from regulated entities by improving our business processes.
During the reporting period, we worked with the complementary medicines industry to create electronic forms that clearly communicate the requirements of each application category. This is expected to minimise the need for us to seek additional information.
Reform activities have also been introduced over this period to streamline the prescription medicine application processes and engage with sponsors prior to submitting their applications. One of the key elements was the consolidation of regulatory requests issued under section 31 of the Therapeutic Goods Act 1989 at a single stage in the evaluation process. This has reduced the number of requests sent to sponsors during the evaluation process.
KPI 4.2 Regulators' frequency of information collection is minimised and coordinated with similar processes including those of other regulators so that, as far as possible, information is only requested once.
4.2a Refer to KPI 1.3 - (Progress of business improvements, and other specific projects, so that sponsors will only need to provide some information to the TGA once).
Initiatives to collect information from sponsors, including the new TGA Business Services site, are captured under various business improvement programs as outlined in KPI 1.3b.
Other activities included:
changes were implemented to streamline systems and processes for registering complementary medicines though the alignment of systems with OTC medicines, and reduce effort, including requests for information, by the consideration of comparable evaluations as part of applications
streamlined post-market review processes were developed which improve the timeliness of compliance reviews for listed complementary medicines and reduce requests for information within the review process
a pilot of a simplified pre-submission pathway for prescription medicine registration applications removes the requirement for sponsors to provide summary information to us during the pre-submission phase and then again with the submission dossier. This information is now provided once, in the submission dossier only.
4.2b Information on cooperative activities carried out with international regulators to minimise information collection from industry (such as joint GMP inspections).
We regularly share manufacturer inspection schedules with the United States of America's Food and Drug Administration (US FDA), the European Medicines Agency (EMA) and Health Canada. This activity aims to identify opportunities for joint inspections with international regulators and therefore minimise the burden on industry. Nine joint GMP inspections were conducted during this period, with agencies including the EMA, EU member state regulators, the European Directorate for the Quality of Medicines and Healthcare (EDQM), the US FDA, Medsafe New Zealand, Health Canada and Medicines Control Council of South Africa.
Collaboration on generic medicines for the reporting period resulted in agreement of a common template for Drug Master Files, new ingredients code tables for eBusiness Services (eBS) and revised guidelines on biosimilar medicines. We also published two OTC medicine monographs that were developed with Health Canada. This will enable more OTC medicines to be processed requiring less information to be provided in the application for registration.
We also have an active role in the development of the international model for a Medical Devices Single Audit Program (MDSAP) through the IMDRF. The pilot is intended to allow MDSAP recognised auditing organisations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the multiple regulatory authorities participating in the pilot program.
KPI 4.3 Regulators utilise existing information to limit the reliance on requests from regulated entities and share the information among other regulators, where possible.
4.3a The use of information from, or in collaboration with, other regulators; for example, development of processes for sharing with international regulators, the number of product evaluation and inspection reports shared.
We have strong active working relationships with major overseas regulators including the United States, Canada, New Zealand, Singapore and European countries. Information sharing with international regulators is further facilitated through participation in forums and consortia such as the International Coalition of Medicines Regulatory Authorities (ICMRA), International Generic Drug Regulators Program (IGDRP), the Australia, Singapore, Switzerland, Canada (ACSS) consortium, International Conference on Harmonisation of Technical Requirments (ICH) and the Regulatory Cooperation Initiative (RCI) with Health Canada.
Examples of collaboration and information sharing with other regulators during the reporting period include:
chairing the ICMRA Generic Medicines Working Group that developed a draft policy paper proposing information sharing priorities for regulators on generic medicines
chairing the ICMRA pharmacovigilance working group to progress work in three key areas:
how to best utilise 'big data' for pharmacovigilance purposes
increasing the rates of adverse event reporting, in particular from health care professionals; and
linking existing systems in order to improve global pharmacovigilance warnings information sharing
adopting the IGDRP evaluation templates for our assessment of Biopharmaceuticals Classification System-based biowaivers and Active Substance Master Files/ Drug Master Files to streamline the submission requirements for the medicines industry
commencing a generic medicine work sharing trial with other regulators in the ACSS consortium and a leading industry stakeholder
use of foreign review information in assessments of domestic generic drug/medicine applications. Eight generic medicine submissions and four drug master file reports were received from a foreign regulator
undertaking desktop clearances for manufacturers in place of inspections, taking into consideration regulatory decisions by other comparable regulators. Of the 2,725 approved clearances, 2,590 (or 95%) were based on evidence from other regulatory agencies.
4.3b Collaborative work undertaken with health professionals. For example, interactions on significant medicine shortages, recall actions or safety issues.
At the request of the Council of Australian Governments (COAG) Health Council, we established a working party on medicines shortages. The working party consists of jurisdictional, professional and pharmaceutical industry representation, with the purpose of developing additional strategies to improve the management of medicine shortages. The working party developed the following recommendations for COAG Health Council consideration:
improve awareness of the Medicine Shortages Information Initiative (MSII) and ensure the shortages are notified to the MSII in a more timely and comprehensive manner, with information kept up to date
more proactively identify alternative sources of supply of suitable medicines
ensure appropriate clinical advice is provided when there is a medicine shortage that will significantly affect patient care
review procurement strategies and protocols on dealing with medicine shortages to ensure consistency in the public health sector
notification of medicine shortages remains voluntary (with information published on shortages when a pharmaceutical company will not report the shortage).
Further activities include:
collaboration with ACT Health and NSW Health in undertaking the "inSite" pilot project to educate health professionals about medical device adverse event reporting and encourage reporting to us
in conjunction with ARCS Australia, several workshops for industry on activities to improve the quality of risk management plans.
KPI 4.4 Regulators base monitoring and inspection approaches on risk and, where possible, take into account the circumstance and operational needs of the regulated entity.
4.4a Refer to KPI 3.3 - (information on activities undertaken to ensure that a risk-based approach is taken to monitoring and compliance activities).
KPI 3.3 outlines the activities undertaken to ensure that a risk-based approach is taken to our monitoring and compliance activities.
In addition to these activities, we have streamlined and coordinated compliance activities so that the circumstances and operational needs of industry are also considered. Information gathered from monitoring and surveillance activities is shared with pre market areas and inspectors. This information is subsequently used in risk assessments for activities such as proactive compliance reviews of therapeutic goods and schedules for inspections of manufacturing facilities.
A Regulatory Intelligence Section has been established to develop and implement strategic, tactical and operational intelligence capability. This intelligence capability is intended to provide intelligence led, risk-based predictive intelligence to support proactive compliance, enforcement and investigatory activity.
We have self-assessed the result as "substantially" rather than "fully" met as TGA does not yet have a fully mature compliance and enforcement framework with graduated sanctions and penalties. While we have a sound compliance structure in place, we do not yet have a range of regulatory tools which allow us to use the full range of compliance approaches.
On this page: KPI 6.1 Regulators establish cooperative and collaborative relationships with stakeholders to promote trust and improve the efficiency and effectiveness of the regulatory framework. | KPI 6.2 Regulators engage stakeholders in the development of options to reduce compliance costs. This could include industry self-regulation, changes to the overarching regulatory framework, or other strategies to streamline monitoring and compliance approaches. | KPI 6.3 Regulators regularly share feedback from stakeholders and performance information (including from inspections) with policy departments to improve the operation of the regulatory framework and administrative processes.
KPI 6.1 Regulators establish cooperative and collaborative relationships with stakeholders to promote trust and improve the efficiency and effectiveness of the regulatory framework.
6.1a Market research conducted on an annual basis to measure consumer, health professional and industry trust in - and engagement with - the regulatory framework.
The information retrieved from our market surveys is utilised to ensure that we help stakeholders make more informed decisions about therapeutic goods and comply with our regulatory requirements.
During the reporting period we surveyed 449 health professionals, 65 consumers and 1,628 members of industry via a public survey to gauge each group's:
level of awareness of therapeutic goods regulation, the TGA and specific regulatory activities
perceptions and support for us
preferred sources of information about the regulatory system
previous contact with us and use of existing information services.
Key findings in relation to trust in the regulator, based on cooperative and collaborative relationships, for the three major stakeholder groups are outlined below.
Trust to perform role ethically and with integrity 71% 83% 87%
Provide safeguards for the health of Australians 58% 74% 77%
Stakeholders were mainly satisfied or very satisfied with our communication and consultation processes, however, overall only 50% of stakeholders felt that the TGA consulted them on relevant issues.
Satisfaction with communicating with the TGA 59% 57% 64%
Dissatisfaction with communicating with the TGA 22% 18% 15%
Satisfaction with consultations with the TGA 64% 63% 62%
Dissatisfaction with consultations with the TGA 0% 22% 12%
Between February and April 2016, 40 in-depth one hour interviews were conducted with industry stakeholders, including representatives from large companies as well as small to medium enterprises, to find out more about their experience of dealing with the TGA online. Interviews were conducted with people from prescription medicines, complementary and OTC medicines, devices, and manufacturing sectors.
6.1b Stakeholder engagement and satisfaction with TGA consultative processes.
Percentage of stakeholders who were satisfied or very satisfied with our consultative processes 67%
Percentage of stakeholders who were dissatisfied with our consultative processes 10%
The data for this output was obtained through the annual program of market research reported under KPI 6.1(a).
KPI 6.2 Regulators engage stakeholders in the development of options to reduce compliance costs. This could include industry self-regulation, changes to the overarching regulatory framework, or other strategies to streamline monitoring and compliance approaches.
6.2a Evidence of continuous compliance with our practice of engagement with industry before a RIS is finalised.
Industry was consulted on the two RISs finalised during the reporting period. This minimised the potential for unintended impacts on regulated entities and product supply. Refer to KPI 1.2a for more information on RIS consultation during this period.
We also engage with regulated entities prior to minor or machinery changes that may not require a RIS, such as updates to guidelines, and improvements to forms and systems used to conduct business. These consultative processes are consistent with our commitment to minimise the potential for unintended financial or resource impacts on regulated entities and product supply consultation. Refer to KPI 2.2a for information about our formal consultations during the reporting period.
Detailed information on our consultations can also be found on our website.
6.2b Progress of business improvements and other projects aimed at reducing compliance costs.
We aim to reduce compliance costs to our regulated entities by regularly engaging with our stakeholders and maintaining a cycle of continuous business improvements, including:
launch of the TGA Business Services website
transition to eCTD technical files for prescription medicines
introduction of the ACE scheme
introduction of the pre-submission pilot pathway for prescription medicines applications
implementation of electronic lodgement of CTN
ongoing development of an online application form for minor variations relating to prescription medicine applications
introduction of regulatory reforms to the IVD Framework (in particular, regulation of in-house IVD tests) with a transition period until 30 June 2017 for in-house IVDs.
During the period, there was progress in implementing digital prescription and OTC medicine submissions and monitoring systems including a new fee model for OTC medicines.
For more information, refer to KPIs 1.3b and 4.2a.
KPI 6.3 Regulators regularly share feedback from stakeholders and performance information (including from inspections) with policy departments to improve the operation of the regulatory framework and administrative processes.
6.3a Information on cooperation and collaboration with policy areas of our Department.
These activities included:
collaboration with representatives from the Office of Health Protection and Jurisdictional Immunisation Coordinators from the states and territories regarding vaccine safety issues
liaison with the Medical Benefits Division to support the activities of the Prostheses List Advisory Committee, including alignment of ARTG inclusions and the Prostheses List following the reclassification of joint replacement prostheses
working with the Best Practice Regulation Branch to provide input on regulatory reform activities, including the Review of Medicines and Medical Devices Regulation
representation on the World Health Organisation International Non-proprietary Names Consultations. The outcomes of the consultations and implications of the adoption of the biological qualifier were conveyed to the Pharmaceutical Benefits Division
collaboration with the Pharmaceutical Benefits Division and Medical Benefits Division to utilise datasets to establish mechanisms for effective post-market monitoring
collaboration with the Preventative Health Policy Branch on the Food-Medicine Interface Protocol
collaboration, in conjunction with the Pharmaceutical Benefits Division, on improving a mechanism to share information regarding prescription medicines submitted under the TGA-Pharmaceutical Benefits Advisory Committee Parallel Process. This information sharing is intended to minimise requests for information from sponsors.
6.3b Information on interactions with other Australian government departments, regulators and statutory authorities.
As part of the Health Department, we collaborate with other Australian government agencies on a range of regulatory issues to ensure a consistent approach. During the period we engaged with:
Food Standards Australia New Zealand, on health claims and novel ingredients
state and territory food authorities, regarding enquiries on products at the food-medicine interface
the ACCC, on safety related recalls
the Department of the Environment, on the rapid evaluations templates they use for chemical assessments
HealthPACT, reviewing new and innovative devices
the Department of Immigration and Border Protection, to develop targeted approaches to prevent the import and/or export of illegal therapeutic goods
the Department of Agriculture and the Department of Immigration and Border Protection to collaborate and share information technology design, systems and learnings
the Productivity Commission, on its public inquiry into Australia's Intellectual Property Arrangements
the Department of Foreign Affairs and Trade, prior to the Trans-Pacific Partnership negotiations in 2015
the National e-Health Transition Authority, on Australian medicines terminology and specifically changes to medicines ingredient names
the National Health and Medical Research Council, to update guidance documents relating to conduct of clinical trials in Australia
state and territory jurisdictions represented on our committees, e.g. Advisory Committee on Chemicals Scheduling and Advisory Committee on Medicines Scheduling.
V1.0 Original publication Regulatory Engagement and Planning Branch September 2016


Japan's northernmost island of Hokkaido is blessed with some of Japan's most dynamic and awe-inspiring natural environments, which include old-growth forests, pristine lakes, scenic mountains and vast oceans. Greatly inspired by this natural environment, the Tsuruga Group is committed to providing its guests with warm hospitality and distinct resort accommodations only made possible in Hokkaido.
Eastern Hokkaido as well as Lake Shikotsu and Jozankei each have a unique history and charms of their own. In addition to world-class hot springs, each resort property features a distinct design concept and character that provides guests with an environment where they can relax and unwind amidst the wonders of nature. Each resort has also earned a reputation for its fine dining that capitalizes on the treasure trove of fresh foods found in Hokkaido. Our hotel restaurants serve a kaleidoscope of seasonal favorites and delicacies using a menu that is refined daily by the head chef.
The Tsuruga Group also recognizes that working closely with the local community to develop health and eco tourism programs as well as tourism resources plays an integral role in revitalizing local economies. In this regard, we stand committed to being a fixture in the local community for many years to come.
Join us at one of our resort properties to discover a truly amazing Hokkaido getaway experience like no other.


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Good luck on this Bareburger Giveaway!
This post is sponsored by Bareburger. Thanks for supporting the brands that support We Heart Astoria.
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Bob Goodale is a former Harris Teeter CEO and former NC Deputy Secretary of Commerce. In addition to his past service on the Healing Transitions Board of Directors and current service on the Board of Trustees, Bob serves on the Board of Directors of Montford Hall, Pavillon and the Alcohol and Drug Council of North Carolina where he also served as President. He previously served on the Hanley-Hazelden Foundation Board of Directors, Hazelden National Advisory Committee; Hazelden, New York City Advisory Board, North Carolina Department of Corrections Substance Abuse Advisory Board; Rebound, Charlotte Board of Directors, Amethyst Foundation, Chairman of the Board and the Charlotte Treatment Center Board of Directors and Capital Campaign Chairman.
Bob served in the Army after receiving a B.S. degree from Iowa State University. He also received an M.B.A. from the University of Kansas. Bob's honors include the Trotter/Black Award, Hope Haven, Charlotte "For his unique contributions in the field of recovery" and the Order of the Hornet, Mecklenburg County, NC Board of County Commissioners' highest award. Bob's story of addiction and recovery is told in SECOND CHANCES by Gary Stromberg.