The Pharmaceutical Regulatory Affairs in Asia provides a practical overview of pharmaceutical regulatory affairs in Asia, focusing on gaining and maintaining successful marketing authorisations across various countries in the region.
Key Topics
Overview of the requirements for local manufacturing
Harmonisation initiatives
Recent developments
Discussion of underlying official regulatory sources
Interpretation of practical aspects
An update and wider knowledge of regulatory affairs in Asia
ASEAN opportunities
Company and product registration outlines
Japan`s regulatory landscape in Asia
Country-specific and regional requirements
Application process
Who should Attend
Medical directors
Scientists and technical staff in regulatory affairs
Registration departments
Anyone interested in learning about marketing authorisation applications
