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Session 2: Progress in Regulatory Harmonization and Convergence
Session Chair(s)
Maria Guazzaroni Jacobs, PhD
Director, Quality Intelligence, Global Supply
Pfizer Inc, United States
According to the WHO’s Draft Guideline on Good Regulatory Practices, regulatory harmonization is the process by which technical guidelines are developed in order to be uniform across participating authorities in multiple countries, whereas regulatory convergence is a voluntary process whereby regulatory requirements in different countries and regions become more similar or “aligned” over time. Despite the discussions about those notions, there are several ongoing regulatory harmonization/convergence initiatives worldwide. This session will focus in the initiatives sponsored by Asia-Pacific Economic Cooperation (APEC) and International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Michelle Limoli, FDA, will present an update on APEC Regulatory Harmonization Steering Committee and Centers of Excellence, and Jared Auclaire, Northeastern University, will discuss the ICH training initiatives. During the panel Q&As, Patrick Brady, Bayer, will present the regulated industry perspective
Learning Objective :
Speaker(s)
APEC Regulatory Harmonization Steering Committee and Centers of Excellence Update on the APEC RHSC and CoE Activities (Presented by Jared Auclair)
Michelle Limoli, PharmD, RPh
FDA, United States
Senior International Health Science Advisor, Office of the Director, CBER
Industry Perspective on Harmonization/Convergence Initiatives
Patrick Brady, PharmD
IQVIA, United States
Global Head, Therapeutic Innovation & Regulatory Science
ICH Training Initiatives
Jared Auclair, PhD
Northeastern University, United States
Vice Provost Research Economic Development; Director Bioinnovation
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