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Regulatory CMC and Product Quality Hot Topics Discussion
Session Chair(s)
Demetra Macheras, MBA
Director, Regulatory Policy and Intelligence - Regulatory Affairs
AbbVie, United States
This interactive forum will bring together senior industry experts to discuss their perspectives on critical hot topics impacting Regulatory CMC and Product Quality.
Learning Objective : Discuss current regulatory CMC challenges, including the use of AI, digitization, and emerging technologies in pharmaceutical quality systems; Examine how to analyze strategies for managing global regulatory complexity, supply chain resiliency, and international harmonization.
Speaker(s)
Panelist
Representative Invited
European Medicines Agency, Netherlands
Panelist
Representative Invited
FDA, United States
Panelist
Representative Invited
FDA, United States
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