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Regulatory Convergence for CMC Requirements: The Challenges and Benefits of a Single Global Dossier
Session Chair(s)
Ana Padua, MSC, RPH
Director EU Global Regulatory and Scientific Policy , Merck Kgaa, Darmstadt, Germany (EMD Serono, US), Switzerland
The session will share concrete experiences and expectations for the use of a single global dossier for CMC requirements. The panel will bring perspectives of regulators and industry, connecting the topic to regulatory convergence and reliance.
Learning Objective : Identify the benefits of a single global dossier strategy for regulatory convergence and reliance initiatives in the area of CMC; Describe experiences from multinational companies with the implementation of harmonized dossier content for global submissions; Analyze and discuss the challenges and opportunities perceived by regulators for the use of a single global dossier for CMC requirements.
Speaker(s)
ICH M4Q(R2): Opportunity for One Global Dossier
Director, Office of New Drug Products, OPQ, CDER, FDA, United States
EMA's perspective: Single Global Dossier
Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
ANIVSA's perspective: Single Global Dossier
General Manager of Medicines, ANVISA, Brazil
Industry Case Study
Regional Regulatory Hub Team Lead, Pfizer Inc, Uruguay
Industry Case Study
Global Head International Regulatory Policy, Roche, Switzerland
Panelist
Associate Director of the Second Directorate, ANVISA, Brazil
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