This two-hour educational program for patient advocates working for 501(c)(3) organizations brings together law, industry, and FDA experts with deep advocacy experience to equip patient organizations with an understanding of the legal tools and strategies available for interacting with the FDA during the COVID-19 pandemic and afterwards. Learn about continuing opportunities and challenges to effective engagement with FDA, including individuals, coalitions, and public meeting and advisory committees. The public policy-focused course is designed for and offered only to 501(c)(3) patient organizations.

 

Speakers:

Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
James E. Valentine, Associate, Hyman, Phelps & McNamara, PC
Beth P. Weinman, Counsel, Ropes & Gray LLP

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This course is complimentary for staff and volunteers of 501(c)(3) patient or disease organizations. Applications are considered on a case by case basis.

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Preliminary Agenda

subject to change

  1. Overview of FDA’s COVID-19 Medical Product Response
    1. Emergency Use Authorizations & Enforcement Policy
    2. Coronavirus Treatment Acceleration Program: Therapies for COVID-19-Related Use
    3. Enforcement
  2. COVID-19 Impacts on Medical Product Development and FDA Priorities/Personnel
    1. Conduct of Ongoing or New Clinical Trials During COVID-19
    2. Drug and Device Facility Inspections
    3. Impact on Guidance Development Priorities
    4. Virtual or Reduced Public Meetings and Events
  3. Panel Discussion and Q&A

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