Management Forum Logo

Presented by
Management Forum

Pharmaceutical Regulatory Affairs in China Training Course

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

26-27 November 2025
+ 12-13 May 2026, 25-26 November 2026 »
from £1299

Need help? Enrol/reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

Course overview

This two-day webinar offers a comprehensive review of Pharmaceutical Regulatory Affairs in China. It provides participants with the essential knowledge and understanding of the regulatory requirements for conducting clinical trials in the People’s Republic of China (PRC) and for registering pharmaceutical products for the Chinese market.

While the primary focus is on the PRC, the webinar also covers regulatory frameworks in Hong Kong (Special Administrative Region), with brief insights into Macau. Detailed information is provided regarding the registration of pharmaceutical products in both PRC and Taiwan (Republic of China, ROC).

This course also examines pharmaceutical maintenance and other regulatory matters, primarily focusing on innovative products, while including relevant information about generic products.

The programme combines real-world case studies with practical guidance, drawing from the speaker’s own professional experience to explore theoretical scenarios. Participants are encouraged to enrich the discussion by sharing relevant company insights, where appropriate and permitted

Please note: This webinar does not cover Medical Devices, Immunology drugs, or Vaccines.

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
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

Primarily, this webinar is intended for Pharmaceutical Regulatory Affairs professionals interested in working with China (PR China, including the Hong Kong SAR and Macau SAR), as well as Taiwan (Republic of China), to receive updates on recent developments and to exchange information or seek guidance on current challenges.

Regulatory Affairs professionals who are new to dealing with China and the region, and who require extensive background information and training.

This webinar may also be of interest to other team members from related line functions, including:

Marketing
Medicine
Logistics
Production, etc., to gain a general overview and introduction

Enrol/reserve

This course will cover:

Day 1
Day 2

Presentation of participants

Quiz

Drug regulatory systems

Clinical product development

Hong Kong

Regulatory authorities
Regulatory procedures and requirements
Focus on pharmaceutical products
Information sources
Brief clinical trial aspects
Future trends

Macau

Brief overview of regulatory environment
Regulatory authorities
Regulatory requirements
Future trends

Product registration strategies

Outline of regulatory strategy options
Historical development and current opportunities
Practical challenges

Case studies

Variations

HA Interactions

TAIWAN Republic of China

Recent developments

Q&A and quiz

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

26-27 November 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 15142

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 22 Oct

2 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

12-13 May 2026

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 16161

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 07 Apr

2 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

25-26 November 2026

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 16576

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 21 Oct

2 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; and apply only when booking multiple delegates on the same date.