RAPS Webcast – The Shifting Global Regulatory Landscape

By YourEncore Webinars

RAPS Webcast: The Shifting Global Regulatory Landscape

The regulatory landscape has changed drastically over the last few weeks, and we are left wondering how society might change as a result of COVID-19. Check out our webcast, sponsored through Regulatory Affairs Professionals Society (RAPS) and featuring YourEncore Regulatory subject matter experts Joseph Lamendola, Graham Higson, and Steve Pondell, as we discuss current hot topics and emerging challenges affecting regulatory affairs professionals globally.

The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment

Up until mid-March 2020, regulatory professionals were traveling globally, attending meetings with regulatory agencies, planning for FDA Advisory Committees and CHMP Oral Explanations, and attending conferences where regulators would turn up to offer their current thoughts on various aspects of drug development. Now we are all working virtually, wondering how society might change as a result of COVID-19. This webcast does not try to predict how the geopolitical world will change as a consequence of COVID-19, but covers current hot topics and emerging challenges affecting regulatory affairs professionals globally. Questions we discussed include:

  • How will we complete the pivotal clinical trials where recruitment has had to be halted and how will we obtain FDA and CHMP buy-in to the changes we have had to make to patient numbers, endpoints and data collected?
  • Does COVID-19 create opportunities for industry (and regulators) to think what was considered unthinkable just a few weeks ago?
  • How do we manage the inevitable complexity of our Supply Chain when some countries remain locked down?
  • How do regulators accept more ambiguity in their benefit regarding risk assessments?
  • Is this an opportunity for more flexibility with initial approvals and a greater reliance on Post Marketing Requirements/Commitments?

Learning Objectives

  • Have better insight into how interactions with regulatory agencies are likely to change as a consequence of COVID-19
  • Improve your understanding of how clinical trials will need to be conducted in this new environment
  • Increase your understanding of the need to build risk mitigation strategies around the clinical supply chain
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