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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.

24-25 Nov 2021

& 25-26 May 2022 , 22-23 Nov 2022

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Details

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.

Programme

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

Presenters

Alan Chalmers (More...)

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.

Monica Dressler-Meyer (More...)

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.

Book now

Book now

24-25 Nov 2021
Live webinar
24-25 Nov 2021
Live webinar
GBP 1,299.00
EUR 1,859.00
USD 2,098.00
+ VAT @ 20.00%
Enrol now
Limited
places

to attend
Live webinar
25-26 May 2022
Live webinar
25-26 May 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 20 Apr 22*
Enrol now
to attend
Live webinar
22-23 Nov 2022
Live webinar
22-23 Nov 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 18 Oct 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Abbott Laboratories
  • Abbott Products GmbH
  • Bayer Consumer Care AG
  • Biogen International GmbH
  • C.B. FLEET COMPANY INC
  • CHEPLAPHARM Arzneimittel GmbH
  • Ferring Pharmaceuticals Inc
  • Fresenius Medical Care Deutschland GmbH
  • G. POHL-BOSKAMP GmbH & CO. KG
  • Galpharm International
  • Gilead Sciences International Limited
  • Gilead Sciences International Ltd
  • H. Lundbeck A/S
  • Informa Healthcare Limited
  • Lek Pharmaceuticals d.d.
  • Menarini Ricerche
  • Mexichem UK Ltd
  • Nestlé Skin Health
  • Novartis Consumer Health SA
  • Pharma Quality Europe srl
  • PROMED CS Praha a.s.
  • Recordati Ireland
  • SANOFI CHIMIE
  • Sanofi Pasteur SA
  • Siegfried AG
  • Teva Pharmaceuticals
  • Teva Pharmaceuticals Industries Ltd
  • Unilever
  • Wockhardt (UK) Ltd
  • Zambon SpA

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

Rand Qeshta, Regulatory Affairs Manager , Recordati Ireland , Nov 20

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 20

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

Nadège Caminet, Director QA Immunology (CH) / Responsible Person, Swedish Orphan Biovitrum, Nov 20

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 19

Super programme, super speakers!

Lu Dao, Manager Regulatory Affairs, Cheplapharm Arzneimittel GmbH, Nov 19

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

Chek Ing (Agnes) Kiu Weber, CEO, AiGenix Life Science Consulting GmbH, Nov 19

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

Julia Strack, Manager Regulatory Affairs, Cheplapharm Arzneimittel GmbH, Nov 19

Very good. Speakers with great experience.

Mauro Catena, Manager, Helsinn Healthcare SA, Nov 18

Excellent Speakers, helpful discussions during the sessions & coffee breaks

Thorben Bonarius, Global Head Regulatory Affairs, Siegfried AG, Nov 18

Both are really great speakers.

Nermin Ipek, Global Regulatory Affairs Manager, Ferring Pharmaceuticals Inc, Nov 18

The course was good with a lot of valuable information.

Robert Klasson, Manager Regulatory Affairs API, Xellia Pharmaceuticals ApS, Nov 18

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 17

Great

Mia Kiistala, Senior Manager, Biogen, Nov 17

Good - quite interactive, easy to raise questions and get answers.

Hélène Bonnans, Regulatory/Quality Manager, Sanofi Chimie, Nov 17

Dynamic, knowledgeable, interesting presentations

Felicity Lyon-Staniewski, Associate Director, Biogen Ltd, Nov 17