DUBLIN--(BUSINESS WIRE)--The "Pharmaceutical Regulatory Affairs in Asia" conference has been added to ResearchAndMarkets.com's offering.

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 delegates

Benefits of Attending

• Gain an overview of key Asian markets
• Discuss the 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

Agenda

Day 1: China, Hong Kong SAR, Introduction to ASEAN, Brunei and the Philippines

Day 2: India, Indonesia, Malaysia, Singapore, Thailand, Vietnam

Day 3: Taiwan, Korea, brief comparison with Japan, ASEAN harmonisation

Regional presentations covering:

The markets

• Brief commercial and cultural background
• Importance of major markets

Company and product registration

• Regulations and guidelines
• Drug classification systems
• Site registration
• New products
• Line extensions
• Labelling changes
• Sourcing changes
• Registration samples
• Certificates/legalisation

Application process

• Committees/Meetings
• New applications
• Variations
• Renewals/re-registration

Recent regulatory developments

• Influences and changes: national and regional
• The latest regulatory developments in the region

Harmonisation Initiatives

• ASEAN Opportunities

A brief comparison of how Japan fits into the Asian regulatory landscape

For more information about this conference visit https://www.researchandmarkets.com/r/2lmvt2

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

[email protected]
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