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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2023 1:00 PM - Feb 09, 2023 12:35 AM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Panel Discussion: Safety Practices in Small Pharmaceutical Company Settings

Session Chair(s)

James  Buchanan, PharmD

James Buchanan, PharmD


Covilance LLC, United States

Small and mid-sized pharma companies do not have the resources available to large pharma companies which can pose challenges when attempting to meet various regulatory requirements. Implementation of the FDA’s Final Rule has been one example. Under the auspices of the ASA Biopharmaceutical Working Group, a survey was conducted to identify the unique challenges faced by smaller companies to comply with the Final Rule. This session will explore the results of this survey and hear the FDA’s perspective of these concerns.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize key concerns smaller companies have encountered with the FDA Final Rule
  • Describe the types of approaches smaller companies have implemented to deal with resource constraints
  • Discuss FDA’s perspective regarding the concerns of smaller pharma companies


Jacqueline A. Corrigan-Curay, JD, MD


Jacqueline A. Corrigan-Curay, JD, MD

FDA, United States

Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)

Greg  Ball, PhD


Greg Ball, PhD

ASAPprocess, United States

Safety Data Scientist

Representative Invited


Representative Invited

Merck & Co., Inc., United States

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