6:15PM – 8:15PM
ADD-ON DINNER WORKSHOPAnticipate the Greatest Challenges When Facing FDA Advisory Committee Meetings
Dan Cohen, Forum Chair, ABUSE DETERRENT COALITION; Executive Vice President, Government Relations, KEMPHARM
Ernest Kopecky, Vice President, Clinical Development, Head, Global Pain Medicine, TEVA
Under the 21st Century Cures Act, every new opioid will need to clear an FDA advisory committee meeting. Preparing for these meetings can be costly and difficult, especially given the level of background knowledge of committee members. This interactive workshop helps you set expectations for practice meetings, adapt to the likely knowledge and skill levels of committee reviewers, pick the best scientific evidence and language, fine-tune your rapid response tools, and more.
- Differentiate the proper approaches based on whether your company is completely new to the advisory committee process
- Select and work with the process manager that best meets your needs
- Practice persuading committee members who may not have specific experience in relevant medical areas