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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.

★★★★★ "I hoped to receive an overview of the regulatory landscape in CN and received a very deep overview o... more (23)"

26-27 November 2025 »
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

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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 China training course

I hoped to receive an overview of the regulatory landscape in CN and received a very deep overview of the regulatory landscape in the mentioned countries with a lot of facts and knowledge for CN and the territories HK, MO and TW + CN :). I learned a lot and could answer my questions as a take home message.

Jun 25 2025

Susanne Klitzke Germany
Regulatory Affairs Manager, Merz Therapeutics

Jun 25 2025

Very dynamic and engaging presentations. I wanted to gain a general understanding of the structure of the Chinese agency and its various functions, as well as the overall process for finished product registration. I’m truly pleased with the information that was shared — it fully met my expectations. The materials were very comprehensive, containing a wealth of information on the topic and very well organized. The speakers were highly knowledgeable and had a broad perspective on the topic. It was very interactive, making participation easy and encouraged. The platform was excellent in facilitating communication during the presentation.

Montserrat Megias Barrera Spain
RA Manager, inke

Apr 29 2024

Very clear, interesting and worth it!

Mélissa Cardenas Trujillo France
Regulatory Affairs & Registrations Specialist I, Laboratoires Thea Sas

Dec 10 2024

Valuable Webinar and very good interactions with the speakers.

Celine Aubertin France
International Regulatory Affairs Manager, NOOUS FINANCE AU NOM ET POUR LE COMPTE DE PIERRE FABRE SA

Dec 12 2023

The content are useful for my purpose, I receive additional and detailed information. The presentation and speakers are very clear.

Adriana Merlicco Italy
Regulatory, Alfasigma S.p.A.

Nov 22 2022

I would highly recommend [...] I appreciate there were more than one speaker to change it up and make the different topics more varied to listen in on. Also very nice how the speakers would supplement each other when responding to questions

Maria Mikkelsen Denmark
Regulatory CMC Specialist, Ascendis Pharma

Nov 22 2022

I would highly recommend

Maria Mikkelsen Denmark
Regulatory CMC Specialist, Ascendis Pharma

Nov 25 2020

The speakers were very professional, detailed in providing information and they promoted interactions/questions in order to try to deepen together the topics covered.

Teresa Bruno Italy
Regulatory Affairs Officer, Menarini Ricerche Spa

Nov 25 2020

Good rhythm with 2 speakers. Good and clear presentations. Interactive course.

Nadège Caminet Switzerland
Director QA Immunology (CH) / Responsible Person, Swedish Orphan Biovitrum

Nov 25 2020

The speakers were very helpful and supportive in answering any questions.

Rand Qeshta Ireland
Regulatory Affairs Manager , Recordati Ireland

Nov 20 2019

Both presentations were well prepared and presented and Alan and Monica answered further questions.

Julia Strack Germany
Manager Regulatory Affairs, Cheplapharm Arzneimittel GmbH

Nov 20 2019

Super programme, super speakers!

Lu Dao Germany
Manager Regulatory Affairs, Cheplapharm Arzneimittel GmbH

Nov 20 2019

Overall, a very informative introduction to regulatory affairs in Greater China.

Chek Ing (Agnes) Kiu Weber Switzerland
CEO, AiGenix Life Science Consulting GmbH

Nov 20 2019

The course is really interesting and the small group allowed good interactions with the speakers and between the participants.

Céline Anselmetti Switzerland
Debiopharm Research & Manufacturing SA

Nov 27 2018

Excellent Speakers, helpful discussions during the sessions & coffee breaks

Thorben Bonarius Switzerland
Global Head Regulatory Affairs, Siegfried AG

Nov 27 2018

The course was good with a lot of valuable information.

Robert Klasson Denmark
Manager Regulatory Affairs API, Xellia Pharmaceuticals ApS

Nov 27 2018

Both are really great speakers.

Nermin Ipek Denmark
Regulatory Affairs Team Leader, Novo Nordisk

Nov 27 2018

Very good. Speakers with great experience.

Mauro Catena Switzerland
Manager, Helsinn Healthcare SA

Nov 21 2017

Great

Mia Kiistala United States of America
Senior Manager, Biogen

Nov 21 2017

This course was well paced and met my needs in terms of content and interactivity. Both speakers were extremely knowledgeable and approachable which is I believe is important in this setting.

Chris Dodd United Kingdom
Medical Regulatory Manager, Mexichem UK Ltd