Clinical Research Compliance: Multi-Agency Considerations

This engaging CLE session, led by Darshan Kulkarni, Principal Attorney at the Kulkarni Law Firm and adjunct professor at Drexel University School of Law, delves into the complex regulatory landscape governing clinical research. Attendees will explore the intersection of compliance requirements across key agencies, including the Department of Justice (DOJ), the Office of Inspector General (OIG), the Office of Research Integrity (ORI), and state-specific regulations.

The presentation will provide actionable insights on:

• Navigating DOJ and OIG compliance programs.

• Addressing fraud and abuse risks under the False Claims Act, and Anti-Kickback Statute.

• Understanding the implications of privacy laws like HIPAA, and state-specific regulations.

• Managing telemedicine compliance within decentralized clinical trials.

• Leveraging corporate compliance programs to minimize liability.

This session includes real-world case studies, practical compliance strategies, and a discussion on the latest regulatory updates affecting clinical research. Perfect for attorneys, compliance officers, and clinical research professionals looking to deepen their understanding of multi-agency compliance and mitigate legal risks effectively.

Learning Objectives:

1. Identify compliance expectations from key regulatory agencies
2. Analyze case studies to understand common compliance pitfalls
3. Apply strategies to align corporate practices with multi-agency requirements