Presented by
Management Forum
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 (16)"
25-27 February 2025
+ 11-13 June 2025, 8-10 October 2025 »
from £1599
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:
Benefits of attending:
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.
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:The programme consists of regional presentations covering:
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.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
25-27 February 2025
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 14525
Until 21 Jan
Not ready to book yet?
for 7 days, no obligation
11-13 June 2025
Live online
09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Timings may be different for each day
Course code 14746
Until 07 May
Not ready to book yet?
for 7 days, no obligation
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
Until 03 Sep
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.
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.
Oct 9 2024
Aikaterini Andreou
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
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
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
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
France
Germany
Switzerland
Denmark
Spain
Italy
Australia
Belgium
Netherlands
Sweden
Austria
Croatia
Finland
Greece
Ireland
Korea, Republic Of
Portugal
Singapore
Czech Republic
Hong Kong
Hungary
Iceland
Israel
Latvia
Norway
Poland
Slovenia
Thailand
Ukraine
United States of America
3 days
Typical duration
Pricing from:
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: