Learning Launch  Challenge   I am a member of my organization’s Regulatory affairs department and my/our challenge is to  improve the product submission (activities and projects) to US marker and in order to increase  approvals without any major deficiencies. The project scope includes interacting with all cross  function teams, FDA communication related to products changes. The generic products  verified as per guidance for Sterile pharmaceutical or biological medicinal products, GMP  regulations, Regulatory requirement of pharmaceutical products, Health care regulatory  affairs,Clinical safety data management, Clinical investigation of medical devices.    Selection   Our team has to make a regulatory strategy for individual products, so we are ready to try the  learning launch tool. Broadly speaking, the learning launch is an experiment meant to quickly  test an idea and prototype.    Application   For our first learning launch, we focused on the structure/execution of our online marketing  tasks. In particular, we wanted to see if we could structure our tasks, projects, and processes to  adapt the methods of Scrum project management for our work (e.g., time boxed, daily, specific  meetings, reviews, etc.) in an effort to become more agile. This tested our assumption that the  structure and execution were the main causes of our workflow challenge. Our team went  through a two-day training with a Scrum project management coach. Next, we went through  five workshops to structure our tasks and processes in a more agile way. These two sessions  occurred within in a three-week timeframe. We expected to produce a document with a clear  description of our new, more agile processes/workflow.     For our second learning launch, we focused on gaining clarity about our tasks and priorities.  This tested our assumption that our prioritization of tasks was the main cause of our workflow  challenge. Our team completed an anonymous survey. Additionally, five key stakeholders from  the larger marketing department and IT department also completed an anonymous survey. The  surveys included questions about our new, proposed process, understanding the process and  the prioritization of tasks, and feelings about the change, and were conducted within a one- week timeframe.     Insight   By applying the learning launch tool, our team identified our assumptions and designed  launches to test these assumptions. Additionally, we thought through anticipated results,  expecting to find that a more agile approach would improve our workflow, and that both our  team and the key stakeholders would be fairly open to the new prioritization of tasks and  process. Our actual results were slightly different from what we anticipated: while our team  was open to the prioritization of tasks and process, the key stakeholders in the larger marketing  department and IT department expressed some concerns. Moving forward, our team will  review this insight and incorporate it into future launch designs. The ongoing incorporation of  insight is particularly important at this stage, as launches come before a full rollout in the design  thinking timeline.     Approach     Our regulatory affairs team covers a broad range of specific skills and occupations. Under the  best of circumstances, it is composed of a group of people who act as a liaison between the  potentially conflicting worlds of government, industry, and consumers to help make sure that

marketed products are safe and effective when used as advertised. People who work in  regulatory affairs negotiate the interaction between the regulators (the government), the  regulated (industry), and the market (consumers) to get good products to the market and to  keep them there while preventing bad products from being sold.    On the consumer side, people in regulatory affairs help keep the other two groups honest, and  they provide the stimulus for Congress to enact the laws that regulate how government and  industry treat products.

