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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

★★★★★ "The webinar was fantastic as all seminars I attend with Management Forum UK. I will only attend the ... more"

22-24 Feb 2023
+ 2 more dates

Need help? Enrol or reserve

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

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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).

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

Programme

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

Book Pharmaceutical Regulatory Affairs in Asia Live online/Classroom training

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

22-24 Feb 2023

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 12116

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

Until 18 Jan

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

View basket

Not ready to book yet?

for 7 days, no obligation

14-16 Jun 2023

Classroom
Rembrandt Hotel
London

09:00-17:30 UK (London)
Course code 12722

GBP 1,699 1,999
EUR 2,449 2,869
USD 2,801 3,269

Until 10 May

3 days classroom-based training
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

11-13 Oct 2023

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 12369

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

Until 06 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

View basket

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.

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

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.

Nov 15 2021

Angela Turner United States of America
Associate Director GRA,

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