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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

  • work Practice Area

    Health

Date & Time
  • event Date

    Thursday, May 14, 2020

  • 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.


  • Live Online


    On Demand

$297.00

This course is $0 with these passes:

CLE
ALL

This CLE course will guide healthcare counsel on advising clients conducting clinical trials and other research activities during the COVID-19 pandemic.

Faculty

Valerie H. Bonham
Counsel
Ropes & Gray

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 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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Description

The panel will examine recent federal agency guidance on both the conduct and reporting of clinical trials and on flexibilities in federal grant and contract requirements to facilitate research operations in the wake of COVID-19. The panel will also address changes and funding opportunities created by federal legislation passed in response to the COVID-19 pandemic.

The panel will offer guidance and best practices for both ongoing and upcoming trials during the COVID-19 pandemic. Because the panel is composed of attorneys who represent both industry sponsors of research and universities and academic medical centers that serve as clinical research sites, the panel members will offer insights into the relevant guidance and legislation for both types of entities.

Listen as our panel of experienced attorneys provides guidance to healthcare counsel on advising clients conducting clinical trials and other research activities during the COVID-19 pandemic. The panel will discuss the new FDA and NIH guidance as well as other federal agency actions being taken to enable research during the pandemic.

Outline

  1. Challenges for clinical trials during COVID-19
  2. Recent FDA and NIH guidance on the conduct of clinical trials
  3. Privacy considerations and clinical trial reporting
  4. Flexibilities in federal grant and contract requirements and additional funding opportunities resulting from federal COVID-19 legislation
  5. 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?