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.
★★★★★ "Very clear, interesting and worth it!"
10-11 December 2024
+ 31 March-1 April 2025, 25-26 June 2025, 26-27 November 2025 »
from £1099
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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Course overview
This seminar will provide an invaluable overview of how to gain and maintain a successful pharmaceutical marketing authorisation in the People’s Republic of China (PRC), including Hong Kong, Macau and Taiwan.The two-day course will cover:
• All important aspects of gaining and maintaining a successful marketing authorisation in the region
• Recent regulatory reforms
• Drug regulatory systems
• An overview of import and local manufacture registration
• Clinical product development including CMC regulatory requirements
• An interpretation of practical aspects
• The opportunity to exchange experiences with other delegates
Benefits of attending:
Gain an overview of the regulatory procedures in the region
Understand and assess the impact of recent regulatory reforms
Discuss clinical product development and Chinese-specific approaches
Understand requirements for import and local manufacture registration
Discuss product registration strategies
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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 in this region. You will find this seminar useful both as an introductory or refresher course.
Previous delegates have included scientists and technical staff in regulatory affairs and registration departments, medical directors, and personnel from analytical research and development, clinical development, quality assurance, new business development and regulatory authorities.
This course will cover:
General introduction to the PRC and the pharmaceutical market
- Commercial and cultural background
P.R. China - Drug Regulatory Systems
- Regulatory authorities
- Recent regulatory changes
- Regulations and guidelines
- Drug classification systems
- Import and local manufacture registration
- Data requirements
- Registration requirements
- Labelling requirements
P.R. China - Clinical Product Development
- Regulatory aspects of clinical development
- Recent regulatory changes
- Documentation needs including CMC
- Regulatory requirements including GCP aspects
- Chinese-specific approaches
- Multinational clinical trials
Hong Kong SAR
- Background overview
- Regulatory authorities
- Regulatory requirements and procedures
- Specific market aspects
Macau SAR
- Brief overview of regulatory aspects
P.R. China - Regulatory Strategies
P.R. China - Health Authority Interactions
P.R. China - Maintenance
Taiwan (Republic of China)
- Cultural background
- Regulatory authorities
- Regulations and guidelines
- Drug classification systems
- Data requirements
- Country-specific matters
P.R China - Recent Developments
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.
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.
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
10-11 December 2024
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 14074
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 05 Nov
- 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
Not ready to book yet?
for 7 days, no obligation
31 March-1 April 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 14652
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 24 Feb
- 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
Not ready to book yet?
for 7 days, no obligation
25-26 June 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 14793
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 21 May
- 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
Not ready to book yet?
for 7 days, no obligation
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 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
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
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
Very clear, interesting and worth it!
Apr 29 2024
Mélissa Cardenas Trujillo 
Regulatory Affairs & Registrations Specialist I, Laboratoires Thea Sas
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 
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 
Regulatory CMC Specialist, Ascendis Pharma
Nov 22 2022
I would highly recommend
Maria Mikkelsen
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
Regulatory Affairs Officer, Menarini Ricerche Spa
Nov 25 2020
Good rhythm with 2 speakers. Good and clear presentations. Interactive course.
Nadège Caminet 
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 
Regulatory Affairs Manager , Recordati Ireland
Nov 20 2019
Both presentations were well prepared and presented and Alan and Monica answered further questions.
Julia Strack 
Manager Regulatory Affairs, Cheplapharm Arzneimittel GmbH
Nov 20 2019
Super programme, super speakers!
Lu Dao
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
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
Debiopharm Research & Manufacturing SA
Nov 27 2018
Excellent Speakers, helpful discussions during the sessions & coffee breaks
Thorben Bonarius
Global Head Regulatory Affairs, Siegfried AG
Nov 27 2018
The course was good with a lot of valuable information.
Robert Klasson
Manager Regulatory Affairs API, Xellia Pharmaceuticals ApS
Nov 27 2018
Both are really great speakers.
Nermin Ipek
Global Regulatory Affairs Manager, Ferring Pharmaceuticals Inc
Nov 27 2018
Very good. Speakers with great experience.
Mauro Catena
Manager, Helsinn Healthcare SA
Nov 21 2017
Great
Mia Kiistala 
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 
Medical Regulatory Manager, Mexichem UK Ltd
Nov 21 2017
Dynamic, knowledgeable, interesting presentations
Felicity Lyon-Staniewski
Associate Director, Biogen Ltd
Nov 21 2017
Good - quite interactive, easy to raise questions and get answers.
Hélène Bonnans
Regulatory/Quality Manager, Sanofi Chimie
Nov 24 2016
The speakers were very nice, easy to understand and available
Antoine Halais
Regulatory Expert, Nemera
Switzerland
- AbbVie AG
- AiGenix Life Science Consulting GmbH
- Ares Trading SA
- BACHEM AG
- Biogen
- Biogen International GmbH
- Cerbios-Pharma SA
- CSL Behring AG
- Debiopharm Research & Manufacturing SA
- F. Hoffmann-La Roche Ltd
- Helsinn Healthcare SA
- Horus Pharma International
- Merck Serono SA
- Nestlé Skin Health
- Novartis Consumer Health SA
- Novartis Vaccines & Diagnostics AG
- ObsEva
- Oculis
- OM Pharma SA
- Siegfried AG
- Stragen Pharma SA
- Swedish Orphan Biovitrum
- SWISS REINSURANCE COMPANY
- Valeant Pharma Switzerland GmbH
France
- Becton Dickinson
- chiesi
- Chiesi SAS
- Guerbet
- HRA PHARMA
- Ipsen Pharma SAS
- LABORATOIRE HRA PHARMA
- Laboratoires Thea Sas
- LFB Biomedicaments
- Nemera
- PIERRE FABRE MEDICAMENT
- Sanofi Chimie
- Sanofi Pasteur SA
- Sanofi R&D
- Science Union SA
- Septodont
- STALLERGENES
- stallergennes greer
- Thomson Reuters
- Vetoquinol SA
United Kingdom
- Abbott Laboratories Ltd
- AbbVie
- Bespak
- Biogen
- Biogen Ltd
- Business Monitor International Ltd
- Galpharm International
- Gilead Sciences International Limited
- Gilead Sciences International Ltd
- Gilead Sciences Limited
- GlaxoSmithKline
- Home
- Informa Healthcare Limited
- Jazz Pharmaceuticals
- Mexichem UK Ltd
- Nelsons
- Reckitt Benckiser Healthcare (UK) Ltd
- Travere Therapeutics Ireland Limited
- Unilever
- Wockhardt UK Ltd
Germany
- Abbott Products GmbH
- AiCuris Anti-infective Cures AG
- Bayer Consumer Care AG
- Cheplapharm Arzneimittel GmbH
- Dr. Willmar Schwabe GmbH & Co. KG
- Engelhard Arzneimittel GmbH
- Fresenius Kabi Deutschland GmbH
- Fresenius Medical Care Deutschland GmbH
- G. POHL-BOSKAMP GmbH & CO. KG
- Haeske Consulting
- LTS Lohmann Therapie-Systeme AG
- Merck KGaA
Denmark
- Alk Abello A/S
- Ascendis Pharma
- Ascendis Pharma A/S
- Ferring Pharmaceuticals A/S
- Ferring Pharmaceuticals Inc
- H. Lundbeck A/S
- Novo Nordisk
- Novo Nordisk A/S
- RHEOSCIENCE A/S
- Xellia Pharmaceuticals ApS
- Zealand Pharma
Italy
- Acs Dobfar Spa
- Alfasigma S.p.A.
- Alfasigma SpA
- Menarini Ricerche
- Menarini Ricerche Spa
- Pharma Quality Europe srl
- Skillpharma S.r.l.
- Zambon SpA
United States of America
- Abbott Laboratories
- AbbVie Inc.
- Biogen
- C.B. FLEET COMPANY INC
- Jazz Pharmaceuticals
- Teva Pharmaceuticals
Ireland
- EirGen Pharma
- Janssen Sciences Ireland
- Janssen Sciences Ireland Uc
- Recordati Ireland
Belgium
- Bristol-Myers Squibb SA
- Datwyler Pharma Packaging International
- GALAPAGODS NV
Croatia
- Xellia d.o.o.
- Xellia d.o.o. (Xellia Ltd.)
- Xellia Ltd
Finland
- Orion Corporation
- Orion Corporation Orion Pharma
- Orion Oyj
Spain
- FAES FARMA, S.A.
- Grifols S.A.
- Grifols,S.A.
Czech Republic
- PRO.MED.CS Praha a.s.
- PROMED CS Praha a.s.
Latvia
- AS Kalceks
- Grindeks JSC
Netherlands
- Abbott Biologicals BV
- Synthon BV
Austria
- Baxalta Innovations GmbH
Canada
- Ripple Therapeutics
China
- DEQI LAW CORPORATION
Greece
- Pharmathen Pharmaceutical SA
Israel
- Teva Pharmaceuticals Industries Ltd
Norway
- Photocure ASA
Poland
- Polpharma SA
Slovenia
- Lek Pharmaceuticals d.d.
Sweden
- Immedica Pharma AB
Run Pharmaceutical Regulatory Affairs in China Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
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:
