Back to Agenda
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)
Lawrence Yu, PHD
Director, Office of New Drug Products, OPQ, CDER, FDA, United States
ICH M4Q(R2): Opportunity for One Global Dossier
Evdokia Korakianiti, PHARMD
Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
EMA's perspective: Single Global Dossier
Nélio Cézar de Aquino, MSC
General Manager of Medicines, ANVISA, Brazil
ANIVSA's perspective: Single Global Dossier
Agustin Brito Del Pino, RPH
Regional Regulatory Hub Team Lead, Pfizer Inc, Uruguay
Industry Case Study
Susanne Ausborn, PHD
Global Head International Regulatory Policy, Roche, Switzerland
Industry Case Study
Patricia Oliveira Pereira Tagliari, LLM, MPH
Associate Director of the Second Directorate, ANVISA, Brazil
Panelist
Have an account?