FDA/OHRP Harmonization and Your HRPP Operations

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.

Learning Objectives:

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

Moderated By

Cheryl Byers

MHA, CHRC, CIP

SVP
Advarra Consulting

Presented By

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

Who should watch?

This content applies to VPs of Research, Institutional Officials, IRB/HRPP professionals, research compliance professionals, research professionals from research institutions, academic medical centers, hospital systems, and other sites with local IRBs, research professionals planning and conducting multisite clinical trials, and others involved in IRB/HRPP activities for multisite clinical trials.

CE Credits

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.