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Pharmaceutical Regulatory Affairs in China Training Course: face to face & live webinar

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

25-26 Nov 2020

& 24-25 Nov 2021

Book now

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 - day 1

General introduction to the PRC and the pharmaceutical market

  • Commercial and cultural background

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

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

Programme - day 2

PRC

  • 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

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

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.

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.

Book now

  attend Face to face attend Live webinar
25-26 Nov 2020, Radisson Blu Hotel, Basel, Switzerland, Basel
25-26 Nov 2020 Radisson Blu Hotel, Basel, Switzerland, Basel GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 14 Oct*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 14 Oct*
Enrol now
to attend
Live webinar
24-25 Nov 2021, Venue not yet confirmed
24-25 Nov 2021 Venue not yet confirmed GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 13 Oct 21*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 13 Oct 21*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

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

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Previous customers include...

  • Abbott Products GmbH
  • AbbVie AG
  • AiCuris Anti-infective Cures GmbH
  • Alk Abello A/S
  • Biogen
  • C.B. FLEET COMPANY INC
  • CERBIOS PHARMA SA
  • CHEPLAPHARM Arzneimittel GmbH
  • Debiopharm Research & Manufacturing SA
  • DEQI LAW CORPORATION
  • Engelhard Arzneimittel GmbH & Co. KG
  • F. Hoffmann-La Roche Ltd
  • Galpharm International
  • Guerbet
  • H. Lundbeck A/S
  • Haeske Consulting
  • Informa Healthcare Limited
  • Ipsen Pharma SAS
  • Lek Pharmaceuticals d.d.
  • LFB Biomedicaments
  • ObsEva
  • Orion Corporation Orion Pharma
  • Orion Oyj
  • PROMED CS Praha a.s.
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Teva Pharmaceuticals Industries Ltd
  • Unilever
  • Valeant Pharma Switzerland GmbH
  • Xellia d.o.o. (Xellia Ltd.)
  • Zambon SpA

Super programme, super speakers!

Lu Dao, Manager Regulatory Affairs, Cheplapharm Arzneimittel 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

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

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 are really great speakers.

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

Excellent Speakers, helpful discussions during the sessions & coffee breaks

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

Very good. Speakers with great experience.

Mauro Catena, Manager, Helsinn Healthcare SA, Nov 18

The course was good with a lot of valuable information.

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

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

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

The speakers were very nice, easy to understand and available

Antoine Halais, Regulatory Expert, Nemera, Nov 16