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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
EMD Serono, 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
Lawrence Yu, PhD
FDA, United States
Director, Office of New Drug Products, OPQ, CDER
EMA's perspective: Single Global Dossier
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
ANIVSA's perspective: Single Global Dossier
Nélio Cézar de Aquino, MSc
ANVISA, Brazil
General Manager of Medicines
Industry Case Study
Agustin Brito Del Pino, RPh
Pfizer Inc, Uruguay
Regional Regulatory Hub Team Lead
Industry Case Study
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
Panelist
Patricia Oliveira Pereira Tagliari, LLM, MPH
ANVISA, Brazil
Associate Director of the Second Directorate
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