Presented By Clara Li, VP Regulatory and Strategic Development & Frank Wierckx, Exec Director Regulatory Affairs, Europe

Regulatory Panel Discussion Presentation

There are not that many opportunities to consult agencies like FDA, EMA, Health Canada.  Agency meetings (Pre IND, End of Phase 1, End of Phase 2, scientific advice, oral hearings and other meetings) take an enormous amount of planning and resources. It also takes time e.g. at least 60 days to receive the FDA responses starting from submitting the meeting request or 40/70 days to receive a written response from the SAWP.  The panel will talk about how to plan for a request, the timing of the meeting, the data to provide, and most importantly, how to ask the type of questions to get the information needed to guide your CMC, Nonclinical, and Clinical development programs. After this discussion each attendee should have an understanding of the types of questions that are appropriate to ask at each stage of development and also when to ask the “forward looking” questions that guide future planning. Getting a “yes” answer from health authorities is good, but sometimes getting the “no” is equally important.

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