Session 1
With your fellow regulatory professionals, you will establish a plan of action for the following scenario: The FDA inspected of one of your company’s primary revenue-generating products, and it has been broadly prescribed, but now there are reports of adverse effects that were not observed in clinical studies that served as the basis for approval. The stakes are high as patient safety, and your company's financial future hang in the balance. But there is an opportunity to present an alternative solution to FDA.
How will you approach the meeting? What key points will you emphasize to persuade FDA officials? Most importantly, how will you project the image of a confident and credible leader?
After completing this workshop, you will be able to:
Uncover vital background information about the FDA officials you will meet.
Identify persuasive evidence that resonates with the agency's priorities.
Construct a credible argument that can influence agency decisions.
Master the art of executive presence to command the room.
Prepare for and tackle tough questions with thoughtful, evidence-based responses.