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


Conducted on Thursday, May 14, 2020

Recorded event now available

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Program Materials

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

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.

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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?

Faculty

Bonham, Valerie
Valerie H. Bonham

Counsel
Ropes & Gray

Ms. Bonham is skilled healthcare attorney and nationally recognized expert in research compliance, government and...  |  Read More

Peloquin, David
David Peloquin, J.D.

Attorney
Ropes & Gray

Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the...  |  Read More

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