3-Day Seminar: Pharmaceutical Regulatory Affairs in Asia (London, United Kingdom - April 24-26, 2019) - ResearchAndMarkets.com

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/