The highly anticipated harmonization between the Common Rule and U.S. Food and Drug Administration (FDA) regulations for human subject protections is underway. While it’s by no means complete, the Notice of Proposed Rule Making (NPRM) gave us a glimpse into where the two sets of regulations may intersect and where they may diverge. Thus, we’ve reached a point where institutions should begin considering – and planning for – the impact on their human research protection program (HRPP) operations.

Join us for a discussion on the HRPP opportunities and challenges through FDA and OHRP harmonization. Our expert panelists will outline what harmonization means and important differences potentially remaining between the regulations. They will also share practical steps for HRPPs and institutional leadership to make the most of proposed changes.

• Identify key differences between OHRP and FDA research regulations
• Describe ways harmonization may impact HRPP operations at different institutions
• Define strategies for re-aligning resources to better support more harmonized regulations

• Presenters

Cheryl Byers

MHA, CIP, CHRC

Senior Vice President, Consulting, Advarra

John R. Baumann

Ph.D.

Associate Vice President for Research Compliance, Indiana University
Advarra Consulting

Cynthia Hahn

Managing Expert
Advarra

Julie Ozier

MHL, CHRC, CIP

SVP & IO, IRB/IBC Regulatory
Advarra