The "Pharmaceutical Regulatory Affairs in Asia" conference has been added to ResearchAndMarkets.com's offering.
This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including; China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan.
Course Overview
- Gain an overview of the 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
Why You Should Attend
This seminar will provide an 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 in Asia
- 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
Who Should Attend?
This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance. You will find this seminar useful both as an introductory and/or a refresher course.
Agenda
Day I: China, Hong Kong SAR, Introduction to ASEAN, Brunei and the Philippines
Day II: India, Indonesia, Malaysia, Singapore and Thailand, Cambodia, Laos, Vietnam
Day III: Taiwan, Korea, Brief Comparison of Japan, ASEAN Harmonisation
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
- General country-specific and regional discussions
Close of meeting
For more information about this conference visit https://www.researchandmarkets.com/research/54crvn/3day_seminar?w=4
View source version on businesswire.com: https://www.businesswire.com/news/home/20190222005334/en/
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Laura Wood, Senior Press Manager
press@researchandmarkets.com
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Topics: Drug
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