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

24-26 Apr 2019

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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

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24-26 Apr 2019
24-26 Apr 2019 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • AVENTIS BEHRING ASIA PACIFIC LTD
  • Biocompatibles UK Ltd
  • Biogen International GmbH
  • Bracco Imaging SpA
  • Chiesi Farmaceutici SPA
  • Ferring Pharmaceuticals A/S
  • Gilead Sciences International
  • Ginsana SA
  • GlaxoSmithKline
  • Guerbet
  • H. Lundbeck A/S
  • Jadran Galenski Laboratorij d.d.
  • Kedrion SpA
  • Kyowa Kirin Limited
  • Medicines and Healthcare Regulatory Agency
  • MSD
  • NOVARTIS OPHTHALMICS AG
  • Novo Nordisk A/S
  • Pharmacia AB - Helsingborg
  • Prostrakan Group Ltd
  • S.A. ALCON-COUVREUR N.V.
  • Sanofi Winthrop Industrie
  • Sanofi-Aventis
  • Science Union SA
  • Shire Pharmaceutical Ltd
  • Smith & Nephew Wound Management
  • Takeda Development Centre Europe Ltd
  • TRIMA PHARMACEUTICAL PRODUCTS
  • Valeant Pharma Switzerland GmbH
  • Xellia Pharmaceuticals AsP

Everything was very professional and well organised

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

The course was full of interesting information

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

Great speakers, great over 3 days, great knowledge

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

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

Christine Eliasson, Senior Regulatory Manager, BioGaia AB

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

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

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

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

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

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