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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Health

Date & Time
  • event Date

    Tuesday, October 17, 2023

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$297.00
CLE
ALL

This CLE webinar will guide life sciences companies and research institutions that are conducting or considering conducting clinical trials outside the U.S. The panel will discuss the benefits and barriers and address the U.S. and foreign rules and regulations that must be kept in mind. The panel will offer guidance for those considering clinical trials outside the U.S.

Faculty

Clint D. Hermes
Counsel
Bass Berry & Sims Plc

Clint Hermes draws on his experience as Chief Legal Officer of two research institutions to advise clients on all regulatory and contracting aspects of human and animal research. His work on behalf of the research missions of academic medical centers and life sciences companies has taken him throughout Africa, Asia, the Middle East, and South America.

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Thaddeus R. McBride
Member
Bass Berry & Sims Plc

Mr. McBride represents companies and individuals in international trade regulatory, compliance, investigative, and enforcement matters involving U.S. economic sanctions and economic embargoes, U.S. export controls, FCPA, U.S. anti-boycott controls, U.S. customs and other import controls, anti-money laundering and other banking controls, and U.S. international trade enforcement and regulatory actions.

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Roy Wyman
Nelson Mullins Riley & Scarborough LLP

Description

Conducting clinical trials outside the U.S. offers benefits for industry and academia. For example, conducting trials outside the U.S. can lower a study’s operational costs and speed its completion, and foreign trials can help researchers study diseases not prevalent in the U.S.

But there are also significant challenges. There are U.S. and foreign laws that sponsors and researcher institutions may not realize apply. For example, the Foreign Corrupt Practices Act creates significant risks. In many countries, healthcare is government run and hospitals are government owned. Consequently, conducting clinical trials can result in extensive interaction with foreign officials. Export controls and economic sanctions may also limit what research can be done in particular countries. Proliferating foreign data protection laws may pose traps for companies and institutions. In addition, studies conducted in resource-limited settings can face ethical and logistical burdens not experienced by studies conducted in high-income countries.

Listen as our authoritative panel examines the benefits and barriers of conducting clinical trials outside the U.S. The panel will address the rules and regulations that those considering clinical trials abroad must keep in mind, including FDA and federal funding requirements, HIPAA, the Common Rule, the FCPA, export controls, economic sanctions, data protection laws, and types of foreign laws researchers may encounter. The panel will also discuss best practices to mitigate risk and help ensure project success.

Outline

  1. Conducting clinical trials outside the U.S.
    1. Trends in globalization of clinical trials
    2. Benefits and drawbacks of conducting research abroad, for both industry and academia
    3. What can go wrong
  2. Applicable laws
    1. U.S. research laws
      1. FDA
      2. Common Rule
      3. HIPAA
      4. Federal grant requirements
    2. Foreign laws
      1. Research and related laws
      2. Data protection laws
    3. U.S. laws of general applicability
      1. FCPA
      2. Export control
      3. Sanctions
  3. Practical and operational considerations/best practices

Benefits

The panel will review these and other key issues:

  • What laws apply to privately and federally funded research sponsored by U.S. organizations and conducted overseas?
  • How can U.S. organizations ensure that data from foreign clinical trials is collected in such a way that it can be used as intended?
  • What are best practices to mitigate risk and help ensure project success in foreign clinical trials?