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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

★★★★★ "Overall, this is a good seminar. It is a little long, but that is to be expected looking at the cont... more (17)"

8-10 October 2025 »
from £1599

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Format: Live online
CPD: 18 hours for your records
Certificate of completion

Course overview

Unlock the complexities of Asian pharmaceutical markets with our comprehensive three-day programme on Pharmaceutical Regulatory Affairs. Designed for professionals seeking a deeper understanding of regional regulatory frameworks, this expert-led programme will equip you with the essential knowledge to successfully navigate the diverse and evolving requirements across Asia.

The course offers in-depth coverage of key Asian markets, including China, India, and Korea, providing participants with a clear roadmap for regulatory compliance. It also explores the ASEAN region, featuring Brunei, Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam.

As part of the broader context, the programme includes a brief comparison with Japan to highlight distinctions, although more detailed information is best explored through dedicated courses.

Throughout the three days, you’ll gain critical insights into regulatory pathways, market entry requirements, and the role of clinical trials where applicable, particularly as prerequisites for product registration. In addition, the programme addresses Pharmaceutical Maintenance and a range of other essential regulatory considerations, with a strong emphasis on innovative products and extensive reference to generic pharmaceuticals.

Don’t miss this opportunity to deepen your regulatory expertise and position yourself for success in Asia’s fast-growing pharmaceutical landscape. Reserve your spot today and take the next step in your professional development.

Looking for an in-depth webinar on Greater China? Don’t miss our comprehensive session on Pharmaceutical Regulatory Affairs in China.

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

Benefits of attending

Gain access to a wealth of information, which would otherwise be time-consuming to research
Exchange practical experiences with peers and professionals. This includes relevant case studies
Examine relevant case studies based on real challenges and opportunities
Enhance knowledge and seek reassurance in solving day-to-day regulatory problems
Participate in frequent Q&A sessions that contribute to enhanced know-how and understanding
Receive guidance on optimising the handling of regulatory situations and challenges

Who should attend

This programme is primarily designed for Pharmaceutical Regulatory Affairs professionals:

Those interested in working with Asian countries, seeking updates on recent developments, exchanging information, or obtaining guidance on current challenges
Regulatory Affairs professionals new to the Asian region, requiring extensive background knowledge and training

In addition, the programme may also be of interest to professionals from related functions, such as Marketing, Logistics, Production, and others, who would benefit from a general overview and introduction to Pharmaceutical Regulatory Affairs in Asia.

This programme does not cover Medical Devices, Immunologicals, or Vaccines.

Enrol/reserve

This course will cover:

Introduction to the Asia Region

Introduction to ASEAN

Philippines

Brunei

P.R. of China overview

India

Malaysia

Singapore

Hong Kong SAR overview

Indonesia

Thailand

Quick outlook: Cambodia and Laos

Participants are encouraged to review the materials on Laos and Cambodia in advance and come prepared with any questions for the informal discussion session on Day 2.

Taiwan overview

Korea

Outline on Japan

ASEAN Harmonisation

Enrol/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

8-10 October 2025

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 14989

GBP 1,599 1,899
EUR 2,239 2,659
USD 2,571 3,039

Until 03 Sep

3 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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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

Overall, this is a good seminar. It is a little long, but that is to be expected looking at the contents and countries to be covered. 5* - I would recommend.

Feb 25 2025

Kong Kong Weng-Yip Malaysia
Assistant Manager RA, DUOPHARMA (M) SENDIRIAN BERHAD

Oct 9 2024

Overall it was a lovely experience and quite useful for people working in Regulatory Affairs. Both speakers seemed well informed and quite experienced. They are quite the experts and they put on a lot of work in the presentations.

Aikaterini Andreou Greece
Regulatory Affairs Officer, Pharmathen

Jun 14 2023

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

Srinivas Parimi Australia
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 United States of America
RA Director,

Apr 7 2021

Good, helpful.

Sarah Elisabeth Snedeker Italy
Project Leader, CHIESI FARMACEUTICI SPA

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

Apr 24 2019

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

Karina Kück Denmark
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 Denmark
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 Germany
Regulatory Affairs Manager, HELM AG

Apr 4 2018

Everything was very professional and well organised

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

Apr 4 2018

The course was full of interesting information

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

Apr 4 2018

Great speakers, great over 3 days, great knowledge

Marta Parmar Switzerland
‎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 Sweden
Senior Regulatory Manager, BioGaia AB

Apr 19 2017

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

Aurelia Signorelli Australia
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 United Kingdom
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 United Kingdom
Artwork Co-ordinator, Eisai Manufacturing Limited

Apr 19 2017

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

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

United Kingdom