PDA Capital Area: The Chevron Doctrine Decision and Its Impact Roundtable
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As the time draws near for the 33rd Annual PDA/FDA Joint Regulatory Conference, the PDA Capital Area Chapter wants to further enrich your time in Washington, D.C. by offering you the opportunity to attend this very important and timely Chapter-hosted roundtable discussion.
The Chevron Doctrine Decision and Its Impact
What You Need to Know
When the Supreme Court first issued its decision in the Chevron case more than 40 years ago, the decision was not regarded as a particularly consequential one. But in the years since then, it had become one of the most important rulings on federal administrative law. The Chevron Doctrine has been cited by federal courts more than 18,000 times since.
This past June, the Supreme Court cut back sharply on the power of federal agencies to interpret the laws they administer and ruled that courts should rely on their own interpretation of ambiguous laws and statutes.
The decision will likely have far-reaching effects across the country and the U.S. Federal Agencies that oversee and manage regulations, including the U.S. Food and Drug Administration. The pharma community will face new challenges and uncertainties across drug development, manufacturing and marketing.
Why You Should Attend
At this critical juncture, with unknowns ahead for any industry professionals, it is important to hear from industry experts and leverage their knowledge and insights to aid you and your company in navigating this time of challenge and change.
Meet Your Expert Panel
Join Glenn E. Wright, CEO and President of PDA, Thomas Cosgrove, J.D., Partner at the law offices of Covington & Burling LLP and former Acting Director of CDER’s Office of Compliance, U.S. FDA and Josh Eaton, Sr. Director, Scientific and Regulatory Affairs at PDA, as they discuss this very critical and current hot topic, providing both background on the decision as well as the potential future impact to industry.
PDA’s Glenn E. Wright will open the session with a brief recap of the decision and the potential impact and highlight items that were discussed at the standing room only PDA Week 2024 session on the same topic this past March.
Thomas Cosgrove, former Acting Director of CDER’s Office of Compliance, will follow with an analysis of the ruling's implications and how it could reshape regulatory practices. The session will allow ample time for audience questions.
Glenn and Thomas will draw on themes from recent analyses of future FDA regulations, with the goal of equipping attendees with the knowledge and strategies to navigate the evolving regulatory environment.
PDA’s Josh Eaton will lead and facilitate the multiple discussion opportunities offered to those in attendance. Bring your questions, your concerns and comments and interact with the expert panel and fellow attendees.
What You Gain
- Drawing on themes from recent analyses of future FDA regulations, this session will equip attendees with the knowledge and strategies to navigate the evolving regulatory environment.
- Access to the expert panel to ask your questions, get answers, and express your thoughts.
- Engagement with your fellow attendees at your table and all the attendees who are present.
- Your registration fee for the roundtable will be donated to the PDA Foundation’s Jette Christensen Memorial Early Career Professional Fund.
Who Should Attend
Whether you're a regulatory professional or an industry stakeholder, this session will offer valuable insights to help your organization stay informed and proactive in response to these significant legal developments.
- Date/Time: Sunday, 08 September, 16:00 – 17:30 ET
- Location: Westin Washington, DC Downtown (999 9th Street, NW, Washington, DC 20001)
All paid registration fees for the roundtable will be donated to the PDA Foundation’s Jette Christensen Memorial Early Career Professional Fund. Take this opportunity to learn, interact with your peers and contribute to supporting early career industry professionals.
Event Location
999 9th Street, NW, Washington, DC, 20001 Get DirectionsContact
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Featured Presenters
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Thomas J. Cosgrove, JD
Covington & Burling LLP
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Thomas J. Cosgrove, JD
Covington & Burling LLP
Tom Cosgrove is a partner in Covington’s Food, Drug and Device Practice Group. He joined Covington in 2017 from the Food and Drug Administration (FDA), where he was a senior official charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients. Mr. Cosgrove brings a wealth of experience to bear in helping clients navigate the complex world of pharmaceutical compliance and enforcement in the United States and around the globe.
At FDA, Mr. Cosgrove held senior leadership positions within the Office of Compliance in the Center for Drug Evaluation and Research (CDER), including leading the organization as Acting Director in 2016. Beginning in 2014, he led the Office of Manufacturing Quality (OMQ), where he was responsible for CDER’s enforcement activities covering current good manufacturing practice (CGMP) and drug quality. As Acting Director of CDER Compliance in 2016, Mr. Cosgrove oversaw OMQ as well as the offices responsible for enforcing FDA’s requirements for drug approval and labeling, human drug compounding, drug supply chain security and integrity, and clinical trials and bioequivalence studies.
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Josh Eaton, MS
Senior Director, Scientific and Regulatory Affairs, PDA
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Josh Eaton, MS
PDA
Josh Eaton joined PDA in 2011 as a project manager and is now Senior Director, Scientific and Regulatory Affairs at PDA. He and his team work with PDA members to produce Technical Reports, Points to Consider documents, and feedback on regulatory draft guidance. The S&RA staff also facilitate the activities of the PDA Technical Advisory Boards and PDA Interest Groups. Prior to joining PDA, Josh developed and marketed drug discovery and research reagents and co-founded a small spin-off company based on those technologies. He earned his Master’s degree in Biochemistry and Biotechnology in 2005 from Georgetown University. -
Glenn E. Wright, MA
President and CEO, PDA
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Glenn E. Wright, MA
PDA
GLENN E. WRIGHT is currently the President and CEO, PDA. Glenn has more than 30 years of experience in the pharmaceutical industry. Previously, he served in various technical and senior leadership positions at Exelead, Eli Lilly, Amgen, and Pfizer. He has extensive technical, regulatory, and quality expertise in both small molecule and biologic drug substance manufacturing as well as sterile injectable drug product manufacturing. Glenn has served on the PDA Board of Directors, Science Advisory Board, and Program Advisory Board. In addition, he has chaired numerous PDA meetings, Task Forces, and Steering Committees. Glenn is a frequent speaker at PDA and industry events. He received his BS and MS degrees in Microbiology from Southern Illinois University.
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