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[WEBINAR] Conducting Clinical Trials Outside the U.S.: U.S. and Foreign Rules, Regulations, and Guidance

By Clint Hermes, Thad McBride & Roy Wyman on July 25, 2023
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We will speak at a Strafford webinar providing guidance to life sciences companies and research institutions that are conducting or considering conducting clinical trials outside the United States.

Our panel will address the U.S. and foreign rules and regulations that those considering clinical trials abroad must keep in mind, including Food and Drug Administration (FDA) and federal funding requirements, the Health Insurance Portability and Accountability Act (HIPAA), the Foreign Corrupt Practices Act (FCPA), export laws, and foreign data protection and other laws. The panel will also discuss best practices to mitigate risk and help ensure project success.

The webinar will be held on Wednesday, September 6 from 1:00 – 2:30 p.m. EDT.

Photo of Clint Hermes Clint Hermes

Clint Hermes draws on his deep experience as general counsel at two teaching hospitals to advise clients on regulatory, accreditation, and corporate governance matters in academic medicine. In addition, Clint also offers clients practical advice and insights on all regulatory and contracting aspects…

Clint Hermes draws on his deep experience as general counsel at two teaching hospitals to advise clients on regulatory, accreditation, and corporate governance matters in academic medicine. In addition, Clint also offers clients practical advice and insights on all regulatory and contracting aspects of human and animal research.

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Photo of Thad McBride Thad McBride

Thad McBride advises public and private companies on the legal considerations essential to successful business operations in a global marketplace. He focuses his practice on counseling clients on compliance with U.S. export regulations (ITAR and EAR), economic sanctions and embargoes, import controls (CBP)…

Thad McBride advises public and private companies on the legal considerations essential to successful business operations in a global marketplace. He focuses his practice on counseling clients on compliance with U.S. export regulations (ITAR and EAR), economic sanctions and embargoes, import controls (CBP), and the Foreign Corrupt Practices Act (FCPA). He also advises clients on anti-boycott controls, and assists companies with matters involving the Committee on Foreign Investment in the United States (CFIUS). Thad supports international companies across a range of industries, including aviation, automotive, defense, energy, financial services, manufacturing, medical devices, oilfield services, professional services, research and development, retail, and technology. Beyond advising on day-to-day compliance matters, Thad regularly assists clients in investigations and enforcement actions brought by government agencies, including the U.S. Department of Justice (DOJ), the U.S. Treasury Department Office of Foreign Assets Control (OFAC), the U.S. State Department Directorate of Defense Trade Controls (DDTC), Customs and Border Protection (CBP), the U.S. Commerce Department Bureau of Industry & Security (BIS), and the Securities & Exchange Commission.

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Photo of Roy Wyman Roy Wyman

For nearly 30 years, Roy Wyman has represented a variety of commercial entities on complex data privacy and security matters and related regulatory concerns. He counsels in-house legal departments, c-suites, boards of directors and IT teams as they navigate data privacy and cybersecurity…

For nearly 30 years, Roy Wyman has represented a variety of commercial entities on complex data privacy and security matters and related regulatory concerns. He counsels in-house legal departments, c-suites, boards of directors and IT teams as they navigate data privacy and cybersecurity issues arising under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), General Data Protection Regulation (EU GDPR), Telephone Consumer Protection Act (TCPA), CAN-SPAM Act, state privacy laws like California Privacy Rights Act (CPRA) and other related statutes.

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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    GovCon & Trade
  • Organization:
    Bass, Berry & Sims PLC
  • Article: View Original Source

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