Clinical Trials Abroad: Managing the Legal Risks
Navigating Regulatory and Privacy Challenges, Minimizing FCPA and Other Risks
Recording of a 90-minute CLE webinar with Q&A
This CLE course will provide guidance to counsel for meeting the challenges of conducting clinical trials outside the U.S., including informed consent, Foreign Corrupt Practices Act (FCPA) exposure, and data privacy. The panel will discuss best practices to overcome the regulatory hurdles and risks involved in conducting trials abroad.
Meeting regulatory requirements
- Informed consent
- Indemnity and insurance
- Export control
- Regulations of individual countries
- Ethical challenges
- Best practices
The panel will review these and other key questions:
- What steps can companies take to ensure they obtain appropriate consent from patient subjects?
- What factors should serve as red flags for potential FCPA exposure?
- What best practices should counsel to companies use to ensure information obtained in clinical trials abroad will be acceptable for approval by U.S. agencies?
Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.
She represents pharmaceutical, medical device and biotechnology companies in connection with a wide range of... | Read More
She represents pharmaceutical, medical device and biotechnology companies in connection with a wide range of commercial and regulatory issues, with a particular expertise in global clinical trials and pharmacovigilance matters. She also handles cross-boundary acquisition and investment transactions as well as product supply, manufacturing and development agreements.Close
Foley & Lardner
She has represented hospital systems and academic medical center clients in numerous complex transactions and... | Read More
She has represented hospital systems and academic medical center clients in numerous complex transactions and regulatory projects and has advised on matters such as Medicare reimbursement, Stark and anti-kickback compliance, nonprofit corporate law and governance, and federal tax exemption. She has significant experience in representing life science companies in conducting global clinical trials.Close