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

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Conducted on Tuesday, July 16, 2013

Recorded event now available

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Course Materials

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.

Description

Clinical trials are increasingly being conducted outside the U.S., including the EU, Asia and the Middle East, and this trend is expected to continue. As a result, these organizations face additional risks.

Each country has its own regulations for clinical trials and the regulations of some emerging countries may be difficult to navigate. Further, counsel should provide guidance to clients on good clinical practices and regulatory compliance so that the data can be brought to the U.S. and accepted for FDA approval.

Challenges include obtaining appropriate consent, controlling and protecting data privacy, and avoiding FCPA  violations. Counsel to companies using clinical trials must understand these obstacles and the regulatory requirements to develop strategies to overcome the challenges.

Listen as our authoritative panel examines the regulatory issues facing companies doing clinical trials abroad and discusses some of the risks that arise when conducting the trials outside the U.S. The panel will outline their best approaches on overcoming the regulatory challenges and mitigating the legal risks.

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Outline

  1. Meeting regulatory requirements
    1. Informed consent
    2. Privacy
    3. Indemnity and insurance
    4. Export control
    5. Regulations of individual countries
  2. Overcoming risks
    1. FCPA/corruption
    2. Ethical challenges
  3. Best practices

Benefits

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.

Faculty

Maureen Bennett
Maureen Bennett
Partner
Squire Sanders

She represents pharmaceutical, medical device and biotechnology companies in connection with a wide range of...  |  Read More

Jan Murray
Jan Murray
Of Counsel
Foley & Lardner

She has represented hospital systems and academic medical center clients in numerous complex transactions and...  |  Read More

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