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
press@researchandmarkets.com
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