Latin America Regulatory Conference

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