Clinical Trials During the COVID-19 Pandemic and Beyond: New FDA, NIH Guidance and other Federal Agency Actions to Enable Research
Managing Protocol Changes, Deviations, and Challenges, Plus Flexibilities in Federal Grant and Contract Requirements
Recording of a 90-minute CLE webinar with Q&A
This CLE course will guide healthcare counsel on advising clients conducting clinical trials and other research activities during the COVID-19 pandemic.
Outline
- Challenges for clinical trials during COVID-19
- Recent FDA and NIH guidance on the conduct of clinical trials
- Privacy considerations and clinical trial reporting
- Flexibilities in federal grant and contract requirements and additional funding opportunities resulting from federal COVID-19 legislation
- Best practices for ongoing and future trials
Benefits
The panel will review these and other vital questions:
- What risks does COVID-19 present for clinical trials?
- What recommended actions should sponsors, researchers, IRB administrators, and others take in light of the recent FDA and NIH guidance?
- What does the COVID-19 pandemic mean for sponsored projects officers and federal grant and contract requirements?
- How has recent federal legislation impacted research operations and funding?
Faculty
Valerie H. Bonham
Counsel
Ropes & Gray
Ms. Bonham is skilled healthcare attorney and nationally recognized expert in research compliance, government and... | Read More
Ms. Bonham is skilled healthcare attorney and nationally recognized expert in research compliance, government and internal investigations, integrity, and bioethics. She has nearly 20 years of experience in the U.S. Department of Health and Human Services as a leader in healthcare, life sciences, enforcement and public policy. Ms. Bonham served as a senior advisor in the Office of the Director of the National Institutes of Health and as a senior attorney in the Office of the General Counsel of the HHS.
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David Peloquin
Partner
Ropes & Gray
Mr. Peloquin advises clients on a wide range of legal and regulatory issues in the area of clinical research and... | Read More
Mr. Peloquin advises clients on a wide range of legal and regulatory issues in the area of clinical research and related activities. He counsels academic medical centers, life sciences companies, information technology companies and other clients that sponsor, support and conduct research. With a broad client base and knowledge of a range of laws and regulations, from the Common Rule and FDA regulations, to HIPAA and GDPR, to state and federal fraud and abuse laws—Mr. Peloquin offers clients clear, practical advice on how the complex legal landscape intersects with an array of research activities. In addition to his advisory work, Mr. Peloquin collaborates with the private equity group to conduct regulatory diligence of clinical research investments and works with the firm’s litigation practice on government and civil investigations involving clinical research. He speaks and writes frequently on issues in healthcare law and data privacy.
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