Solution Circles

Conversations That Matter - Interactions with Health Authorities (US and EU Combination Products)

Wednesday, September 16, 2020

10:35 AM – 11:30 AM EDT

Facilitator(s)

Don E. Boyer, HBSc., RAC, FRAP

President, BOYER@RegulatorySolns
Susan B. Stewart, JD, RAC, FRAPS

Chief Regulatory Officer
Kaleido Biosciences

Panelist(s)

JW

John Barr Weiner, JD

Associate Director for Policy and Product Classification Officer, Office of Combination Products
US Food and Drug Administration
Armin Ritzhaupt, PhD, MPH

Scientific Administrator
European Medicines Agency

The way you communicate and establish your relationship with regulatory agencies could make or break your professional reputation. Every interaction with health authorities provides an opportunity to build your credibility. The panel of regulators and industry representatives from around the world join RAPS attendees in an interactive discussion that includes open question and answer, policy updates, and discussion of agency collaborations, and current trends. We want to hear from you during this informal session – there are no presentations – so come prepared with your questions or discussion topics.