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3-Day Seminar: Pharmaceutical Regulatory Affairs in Asia (London, United Kingdom – April 15-17, 2020) – ResearchAndMarkets.com

March 5, 2020 Off By BusinessWire

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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