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Management Forum

Pharmaceutical Regulatory Affairs in Asia Training Course

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

★★★★★ "Alan and Monica have presented very detailed information on all regulatory aspects. Their knowledge ... more (15)"

9-11 October 2024 »
from £1349

Need help?  Enrol or reserve

Course Overview

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 delegate

Benefits of attending:

  • Gain an overview of key 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

Please note that the course will provide an excellent introduction to all the key aspects of regulatory affairs in the Asia region but will not focus specifically or in detail on Chemistry, Manufacture and Control (CMC).


This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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, whether as an introductory or a refresher course.

Previous delegates have included:
  • Scientists and technical staff in
    • Regulatory affairs
    • Registration departments
  • Medical directors


The programme consists of 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

Enrol or reserve

The Pharmaceutical Regulatory Affairs in Asia course will cover:

  • Introduction to the Asia Region
  • Introduction to ASEAN
  • Philippines
  • Brunei
  • PR of China
  • India
  • Malaysia
  • Singapore
  • Hong Kong
  • Indonesia
  • Thailand
  • Vietnam / Cambodia / Laos
  • Taiwan
  • Korea
  • Outline on Japan
  • Asean Harmonisation

Enrol or reserve

Monica Dressler-Meyer
Pharma International

Mónica Dressler-Meyer is DRA Manager based in Switzerland with many years of regulatory experience. She has spent many years in DRA working with different pharmaceutical companies with responsibility for Asia Pacific and lately also for development activities in other regions. Prior to this, she worked at F. Hoffmann-La Roche in Switzerland where she gained several years’ experience in industry basics and pre-clinical research. She has a Degree in Chemistry and Biochemistry from Basel University.

More details

Alan Chalmers
Pharma International

Dr Alan Chalmers is a pharmacist with over 35 industrial experiences mainly in the field of pharmaceutical regulatory affairs. A graduate of Strathclyde University in Glasgow with a B.Sc. in Pharmacy with specialisation in Pharmaceutical Technology, his Ph.D. at Manchester University was in Pharmaceutical Formulation. From 1975-1978 he was Development Officer and Clinical Trials Pharmacist of Allen & Hanburys (part of the then Glaxo group). In 1978 he joined Ciba-Geigy in DRA. Over 20 years were spent with Ciba-Geigy/CIBA/Novartis in all aspects of regulatory affairs including head of a group company DRA in Canada and for many years as Head of Pharma International regulatory affairs.

He has been consultant to the IFPMA, WHO and other international bodies and was Chairman of the Organising Committee of the initial IFPMA Asian Regulatory Conferences in Hong Kong and Singapore and Rapporteur to the more recent conferences in China and Malaysia.

Since 1998 he has been an independent regulatory consultant and is Director of his own consultancy company Pharma International in Switzerland. He has also been director of two UK and Swiss registered pharmaceutical companies with specialised responsibility for international regulatory strategy. More recently as accredited by Swissmedic, Dr. Chalmers is a Qualified Person supporting several Swiss pharmaceutical companies trading internationally with pharmaceuticals and medical devices.

He is published, and his publications include a textbook on International Pharmaceutical Registration, Active Pharmaceutical Ingredients and as Swiss correspondent to the Regulatory Affairs Journals Pharma and Medtech. Since 2012 he has been a member of the Editorial Board, Scrip Regulatory Affairs.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

9-11 October 2024

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 13933

  • GBP 1,349 1,649
  • EUR 1,939 2,359
  • USD 2,201 2,669

Until 04 Sep

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Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Pharmaceutical Regulatory Affairs in Asia training course

Alan and Monica have presented very detailed information on all regulatory aspects. Their knowledge is exceptional and very useful to this webinar.

Jun 14 2023

Srinivas Parimi
Regulatory Affairs Manager - Rest of Asia Pacific, PharmaCare Laboratories Pty Ltd

Nov 15 2021

The webinar was fantastic as all seminars I attend with Management Forum UK. I will only attend the programs at management forum regarding country regulatory affair systems as they have been the most thorough and realistic programs in my 28 years of the pharma industry. I look forward to the next one.

Angela Turner
RA Director,

Apr 7 2021

Good, helpful.

Sarah Elisabeth Snedeker

Apr 24 2019

Both are very experienced on these countries with high knowledge on the regulatory aspects. I can say that my opinion of the course is very positive.

Sonia Dias
Regulatory Affairs Officer, BIAL - Portela & Ca, S.A.

Apr 24 2019

I think the content is very good, even though very extensive

Karina Kück
Graduate Regulatory Professional, H. Lundbeck A/S

Apr 24 2019

Very good, and extensive knowledge in the area, very impressive. Very, very good course, learnt a lot.

Pernille Træholt
Head of Regulatory Affairs and QA, Pharmanovia A/S

Apr 24 2019

A good overview about RA in Asia - the classes given by Monica were a joy to attend!

Andrea Gießmann
Regulatory Affairs Manager, HELM AG

Apr 4 2018

Everything was very professional and well organised

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

Apr 4 2018

The course was full of interesting information

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

Apr 4 2018

Great speakers, great over 3 days, great knowledge

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

Apr 4 2018

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

Christine Eliasson
Senior Regulatory Manager, BioGaia AB

Apr 19 2017

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

Aurelia Signorelli
Regulaotry Affairs Manager, Specialised Therapeutics Australia Pty Ltd

Apr 19 2017

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

Apr 19 2017

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

Apr 19 2017

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

Tania Castanheira
Reg Affairs Associate 1, Gilead Sciences International Ltd

United Kingdom

  • Torbay Pharmaceuticals
  • Actavis UK Ltd
  • AstraZeneca UK Ltd
  • Atnahs Pharma UK Ltd
  • Atnahs Pharma UK Ltd.
  • Biocompatibles UK Ltd
  • Biogen Idec
  • Business Monitor International Ltd
  • Celgene Europe Ltd
  • Clifford Chance LLP
  • Eisai Manufacturing Limited
  • GE Healthcare Ltd
  • Gilead Sciences International
  • Gilead Sciences International Ltd
  • GlaxoSmithKline
  • Kyowa Kirin International plc
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MSD
  • Mundipharma Research Ltd
  • Napp Pharmaceutical Group Ltd
  • Pharm Research Associates UK Ltd
  • Prostrakan Group Ltd
  • pSivida
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Shire Pharmaceutical Ltd
  • Smith & Nephew Wound Management
  • Takeda Development Centre Europe Ltd
  • Vectura


  • Altran Technologies
  • Baxter SAS
  • Becton Dickinson
  • Galderma International
  • Guerbet
  • Horus Pharma
  • Ipsen Pharma SAS
  • Keyrus Biopharma
  • Mylan sas
  • Sanofi Pasteur SA
  • Sanofi Synthelabo Recherche
  • Sanofi Winthrop Industrie
  • Sanofi-Aventis
  • Sanofi-Aventis Recherche & Development
  • Science Union SA
  • Septodont


  • Bayer Pharma AG
  • Cesra Arzneimittel GmbH & Co. KG
  • Cheplapharm Arzneimittel GmbH
  • Dr Willmar Schwabe GmbH & Co
  • Engelhard Arzneimittel GmbH & Co. KG
  • Engelhard Arzneimittel GmbH KG
  • Esteve Pharmaceuticals GmbH
  • Grunenthal GmbH
  • Helm AG
  • Merck Kga A - Werk Darmstadt
  • Merck KGaA
  • Merz Therapeutics GmbH
  • Solvay Deutschland GmbH
  • STADA Arzneimittel AG


  • Actelion Pharmaceutical Ltd
  • APR Applied Pharma Research sa
  • Biogen International GmbH
  • Cerbios-Pharma SA
  • CSL Behring AG
  • F. Hoffmann-La Roche Ltd
  • Ginsana SA
  • HAS Healthcare Advanced Synthesis SA
  • Mundipharma Laboratories GmbH
  • Valeant Pharma Switzerland GmbH


  • Ferring Pharmaceuticals A/S
  • H. Lundbeck A/S
  • Leo Pharma A/S
  • Novo Nordisk A/S
  • Novo Nordisk Pharmatech
  • Pharmanovia A/S
  • Xellia Pharmaceuticals AsP


  • Farmaprojects S.A.
  • Galenicum Health SL
  • Laboratorios Almirall S A
  • Laboratorios CINFA, S.A


  • Antibioticos
  • Bracco Imaging SpA
  • Chiesi Farmaceutici SPA
  • Chiron S.r.l
  • GlaxoSmithKline Vaccines & Diagnostics s.r.l.
  • Kedrion SpA


  • BOC Limited member of Linde Group
  • PharmaCare Laboratories Pty Ltd
  • Private
  • Specialised Therapeutics Australia
  • Specialised Therapeutics Australia Pty Ltd


  • Abbott Healthcare Products BV
  • Centocor BV
  • Eurovet Aniaml Health
  • Janssen Biologics BV


  • Glaxo Smithkline Biologicals
  • Janssen Pharmaceutica NV
  • UCB Pharma SA


  • AstraZeneca AB
  • BioGaia AB
  • Pharmacia AB - Helsingborg


  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • Sandoz GmbH


  • Jadran Galenski Laboratorij d.d.
  • Pliva Croatia Ltd, Teva group


  • Borealis Polymers Oy
  • Orion Oyj


  • Amryt Pharma
  • Jazz Pharmaceuticals

Korea, Republic Of

  • AJOU University


  • BIAL - Portela & Ca, S.A.


  • MSD International GmbH (Singapore Branch)
  • Novo Nordisk Asia Pacific Pte Ltd

Czech Republic

  • PRO.MED.cs Praha a.s.


  • Pharmathen Pharmaceutical SA

Hong Kong



  • CHINOIN Private Co. Ltd.


  • Actavis Group PTC




  • AS Kalceks


  • GE Healthcare AS


  • Adamed Pharma S.A.


  • LEK Pharmaceuticals d.d.




  • Yuria-Pharm LLC

United States of America


Enrol or reserve

Run Pharmaceutical Regulatory Affairs in Asia Live online for your team

3 days

Typical duration

Pricing from:

  • GBP 1,200
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online


We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749