Pharmaceutical Regulatory Affairs in Asia

The pharmaceutical market in Asia is growing at a rapid pace and presents both opportunities and challenges to those wishing to work in the region. Rather than a single market, Asia is a collection of different markets, each with their own regulatory processes, although harmonisation exists within the ASEAN countries.

This seminar will provide a practical overview of the key areas of pharmaceutical regulatory affairs in Asia, including India, and will cover all important aspects of gaining and maintaining a successful marketing authorisation within the region.

The programme will include:

• Discussion of underlying official regulatory sources
• An interpretation of practical aspects
• An overview of the requirements for local manufacturing
• Recent developments
• Harmonisation initiatives
• An update and wider knowledge of regulatory affairs in Asia
• The opportunity to exchange experiences with other delegate

Benefits of attending:

• Gain an overview of key Asian markets
• Discuss outlines of company and product registration
• Understand the application process
• Assess the impact of recent regulatory developments in the region
• Discuss harmonisation initiatives including ASEAN opportunities
• Understand how Japan fits in the Asian regulatory landscape
• Discover general, country-specific and regional requirements

Please note that the course will provide an excellent introduction to all the key aspects of regulatory affairs in the Asia region but will not focus specifically or in detail on Chemistry, Manufacture and Control (CMC).