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Workshop: (11-2023) Exploring FDA Regulations

Designed as an introductory workshop, PRIM&R's "Exploring FDA Regulations" serves as an essential resource for professionals engaged in the study or oversight of FDA-regulated drugs, biologics, and medical devices.

By employing a multifaceted educational approach that includes pre-learning modules, hands-on exercises, and real-world case studies, the workshop aims to equip attendees with the skills necessary to navigate the complex landscape of FDA human subjects research regulations effectively. The instructional content will address a range of critical aspects, from legal frameworks and compliance protocols to specific challenges associated with emerging technologies.

By the conclusion of this intensive training, participants will be proficient in applying the FDA regulatory framework to a variety of real-life scenarios involving clinical trials of drugs, biologics, and medical devices in human subjects.

Don't miss this comprehensive learning opportunity. Register now for PRIM&R's "Exploring FDA Regulations" to secure your spot!


Session 1: November 3, 2023
1:00-3:00 PM ET

Session 2: November 10, 2023
1:00-3:00 PM ET

Session 3: November 17, 2023
1:00-3:00 PM ET


  • Kindra Cooper,  JD, MPA, MA, CIP, is the IRB Director at Creighton University in Omaha, Nebraska, and an Unaffiliated Board Member with Advarra.
  • David Babaian, JD, LLM, CIP, RAC, is a general attorney for the U.S. Department of Veterans Affairs.

Access Interval
Access to live content will be available for 90 days after the recording is made available. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. To earn a certificate, one must complete all required sections and complete the certificate section within the 90-day access period. After access has expired, users can purchase an additional 90 days of access.

If you prefer, you can use this paper registration form. Please send the completed form to

*Please note that you cannot purchase this workshop on behalf of others. If you would like to register a colleague or a group, please fill out the paper form or contact for an invoice