Presented by
Management Forum

Pharmaceutical Regulatory Affairs in China

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

24-25 Nov 2021 + 2 more dates

Enrol now

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

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

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.

Enrol now

The Pharmaceutical Regulatory Affairs in China 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 - Product Registration Strategies

  • Product registration strategies
    • Summary information contrasting import and local manufacture registrations
    • Planning to meet documentation requirements
    • Expediting regulatory approvals
  • CMC regulatory requirements
    • Brief overview of CMC-related issues
  • Variations and renewals
    • Regulatory procedures
  • Documentation expectations

P.R. China - Post Marketing and Maintenance Activities

Taiwan (Republic of China)

  • Cultural background
  • Regulatory authorities
  • Regulations and guidelines
  • Drug classification systems
  • Data requirements
  • Country-specific matters

P.R. China - Health Authority Interactions & Recent Regulatory Developments

  • Health authority interactions
  • Impact of recent regulatory developments

Enrol now

Alan Chalmers

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

Monica Dressler-Meyer

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

Book Pharmaceutical Regulatory Affairs in China Live online training

24-25 Nov 2021

Live online

09:15-17:00 UK (London) (UTC+00)
10:15-18:00 Paris (UTC+01)
04:15-12:00 New York (UTC-05)
Course code 11095

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 20 Oct

Limited places remaining

In your basket 

25-26 May 2022

Live online

00:00-00:00 UK (London) (UTC+01)
01:00-01:00 Paris (UTC+02)
19:00-19:00 New York (UTC-04)
Course code 11921

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 20 Apr

In your basket 

22-23 Nov 2022

Live online

00:00-00:00 UK (London) (UTC+00)
01:00-01:00 Paris (UTC+01)
19:00-19:00 New York (UTC-05)
Course code 11776

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 18 Oct

In your basket 

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


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

Nov 25 2020

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
  • BACHEM AG
  • Biogen
  • Biogen International GmbH
  • Cerbios-Pharma SA
  • CSL Behring AG
  • Debiopharm Research & Manufacturing SA
  • F. Hoffmann-La Roche Ltd
  • Helsinn Healthcare SA
  • Merck Serono SA
  • Nestlé Skin Health
  • Novartis Consumer Health SA
  • Novartis Vaccines & Diagnostics AG
  • ObsEva
  • Oculis
  • Siegfried AG
  • Stragen Pharma SA
  • Swedish Orphan Biovitrum
  • SWISS REINSURANCE COMPANY
  • Valeant Pharma Switzerland GmbH

UK

  • Abbott Laboratories Ltd
  • AbbVie
  • 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
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Unilever
  • Wockhardt UK Ltd

France

  • Becton Dickinson
  • Guerbet
  • HRA PHARMA
  • Ipsen Pharma SAS
  • LFB Biomedicaments
  • Nemera
  • Sanofi Chimie
  • Sanofi Pasteur SA
  • Sanofi R&D
  • Science Union SA
  • Septodont
  • stallergennes greer
  • Thomson Reuters
  • Vetoquinol SA

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 Medical Care Deutschland GmbH
  • G. POHL-BOSKAMP GmbH & CO. KG
  • Haeske Consulting
  • Merck KGaA

Denmark

  • Alk Abello A/S
  • Ascendis Pharma
  • Ferring Pharmaceuticals Inc
  • H. Lundbeck A/S
  • Novo Nordisk
  • Novo Nordisk A/S
  • RHEOSCIENCE A/S
  • Xellia Pharmaceuticals ApS

Italy

  • Acs Dobfar Spa
  • 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

Croatia

  • Xellia d.o.o.
  • Xellia d.o.o. (Xellia Ltd.)
  • Xellia Ltd

Finland

  • Orion Corporation
  • Orion Corporation Orion Pharma
  • Orion Oyj

Belgium

  • Bristol-Myers Squibb SA
  • Datwyler Pharma Packaging International

Netherlands

  • Abbott Biologicals BV
  • Synthon BV

Spain

  • Grifols S.A.
  • Grifols,S.A.

Austria

  • Baxalta Innovations GmbH

Canada

  • Ripple Therapeutics

China

  • DEQI LAW CORPORATION

Czech Republic

  • PROMED CS Praha a.s.

Greece

  • Pharmathen Pharmaceutical SA

Ireland

  • Recordati Ireland

Israel

  • Teva Pharmaceuticals Industries Ltd

Latvia

  • Grindeks JSC

Poland

  • Polpharma SA

Slovenia

  • Lek Pharmaceuticals d.d.

Enrol now

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy