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Panel Discussion: Safety Practices in Small Pharmaceutical Company Settings
Session Chair(s)
James Buchanan, PHARMD
President, 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
Speaker(s)
Jacqueline A. Corrigan-Curay, JD, MD
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, United States
Speaker
Greg Ball, PHD
Safety Data Scientist, ASAPprocess, United States
Speaker
Representative Invited
Senior Director, Clinical Research, Infectious Disease, Merck & Co., Inc., United States
Speaker
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