Pharmaceutical Regulatory Affairs in Asia

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

BENEFITS OF ATTENDING

  • 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 wil provide an overview of the key areas of pharmaceutical regulatory affairs in Asia, including India.

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 refresher course.

Personnel from Analytical Research and Development, Clinical Development, Quality Assurance, new business development departments, regulatory authorities.

Meeting Timings

DAY ONE

09.00 Registration and coffee
09.30 Meeting start
17.00 Meeting end

DAY TWO

09.00 Meeting start
17.00 Meeting end

DAY THREE

09.00 Meeting start
16.30 Meeting end

Programme

Day 1: China, Hong Kong SAR, Introduction to ASEAN, Brunei and the Philippines
Day 2: India, Indonesia, Malaysia, Singapore and Thailand, Cambodia, Laos, Vietnam
Day 3: 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

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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Previous customers include...

  • Abbott Healthcare Products BV
  • Actavis Group PTC
  • Actelion Pharmaceutical Ltd
  • Altran Technologies
  • Antibioticos
  • AstraZeneca UK Ltd
  • Business Monitor International Ltd
  • Celgene Europe Ltd
  • CHINOIN Private Co. Ltd.
  • CHIRON BV
  • CJ CORP
  • Dr Willmar Schwabe GmbH & Co
  • Eisai Manufacturing Limited
  • ELAN PHARMA LTD
  • F. Hoffmann-La Roche Ltd
  • Farmaprojects S.A.
  • Ginsana SA
  • Grunenthal GmbH
  • Janssen Biologics BV
  • Janssen Pharmaceutica NV
  • Keyrus Biopharma
  • Mundipharma Laboratories GmbH
  • Napp Pharmaceutical Group Ltd
  • Sanofi Pasteur SA
  • Sanofi Winthrop Industrie
  • Sanofi-Aventis
  • SERONO INTERNATIONAL SA
  • Specialised Therapeutics Australia
  • Takeda Development Centre Europe Ltd
  • Xellia Pharmaceuticals AsP