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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is a recording from October 2022
In this webinar, experts will present an analysis of FDA's accelerated approvals program, the development strategies that paved the way for these approvals and their outcomes. Currently a hot topic within the biopharmaceutical industry, there are growing concerns regarding the overall premises of the program and its exhaustiveness.
This session will cover a comprehensive analysis of the program. Join us to take a deep dive into past models and much more.
After this program, participants will be able to:
Sheila is a regulatory affairs professional with 13 years of healthcare industry experience including in regulatory intelligence, database management and quality assurance. She has led operational teams with a focus on developing and implementing regulatory strategies, corporate policies and initiatives to promote and ensure compliance with international regulations. Sheila is a BS graduate in Chemistry from the Autonomous University of Barcelona and holds an MS in Pharmaceutical research, development and control from the University of Barcelona.
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