Are you really ready for your end of phase 2 meeting?

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ENDPOINTS
Wednesday, December 4, 2019 | 1pm EST (US and Canada) / December 5, 2am CST (China) / 6pm GMT (UK) 60 min | English

Webinar Details

The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency. Getting the most from this meeting can help successfully launch your phase 3 program and help you begin preparing for your marketing application (NDA/BLA) submission.

This webinar will cover:

  • Goals for your EOP2 meeting
  • What does it mean to be phase 3 ready?
  • Developing the right questions to obtain clarity from FDA
  • Timing considerations
  • Common themes in FDA feedback

Companies nearing completion of their phase 2 studies or who are planning phase 3 programs will benefit from attending this webinar.

More Information

Webinar Type: Recorded

Speakers

David Shoemaker, Ph.D., Senior Vice President, R&D, RHO
David Shoemaker, Ph.D., Senior Vice President, R&D, RHO
Kevin Barber, Ph.D., RAC, PMP, Vice President, Regulatory Strategy & Submissions, rho
Kevin Barber, Ph.D., RAC, PMP, Vice President, Regulatory Strategy & Submissions, rho

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