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

15-17 Apr 2020

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Course Overview


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

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 n Discover general, country-specific and regional requirements

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. Previous delegates have included:

  • Scientists and technical staff in

- Regulatory affairs
- Registration departments

  • Medical directors


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

Book now

15-17 Apr 2020
15-17 Apr 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Altran Technologies
  • Antibioticos
  • AstraZeneca AB
  • Biogen Idec
  • BOC Limited member of Linde Group
  • Business Monitor International Ltd
  • Chiesi Farmaceutici SPA
  • Clifford Chance LLP
  • Engelhard Arzneimittel GmbH & Co. KG
  • Engelhard Arzneimittel GmbH KG
  • F. Hoffmann-La Roche Ltd
  • GE Healthcare Ltd
  • Guerbet
  • LEK Pharmaceuticals d.d.
  • Medicines and Healthcare Regulatory Agency
  • Merck Kga A - Werk Darmstadt
  • Mundipharma Laboratories GmbH
  • Novo Nordisk A/S
  • Pharmacia AB - Helsingborg
  • Pharmanovia A/S
  • Pliva Croatia Ltd, Teva group
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Sandoz GmbH
  • Science Union SA
  • Shire Pharmaceutical Ltd
  • Specialised Therapeutics Australia

Great speakers, great over 3 days, great knowledge

Marta Parmar, ‎Regulatory CMC Lead, Global Emerging Markets, Biogen International GmbH

The course was full of interesting information

Tanja Hammen, Manager Regulatory Affairs, Engelhard Arzneimittel GmbH & Co. KG

Everything was very professional and well organised

Anca-Maria Perian, Regulatory Affairs Manager International, Cesra Arzneimittel GmbH & Co. KG

high speed and a lot to take in. But very useful information

Christine Eliasson, Senior Regulatory Manager, BioGaia AB

I was pleased with the course in terms of content, presentation and speakers

Aurelia Signorelli, Regulaotry Affairs Manager, Specialised Therapeutics Australia Pty Ltd

Monica is brilliant love her enthusiasm and the way she manages the presentation

Tania Castanheira, Reg Affairs Associate 1, Gilead Sciences International Ltd

Excellent contents of regulatory requirements in the region with very good ideas on new requirements and challenges

Salah Chettibi, Regulatory Affairs Manager, Kyowa Kirin International plc

Really good. I do not come from a regs background and some of the content went over my head however even without any prior knowledge I found the course very helpful and could take a lot of information away with me. It was all pitched correctly

Erika Ravitz, Artwork Co-ordinator, Eisai Manufacturing Limited