Pharmaceutical Regulatory Affairs in China

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

20-21 Nov 2019

GBP 1,499
EUR 2,099
USD 2,338

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 includ- ing 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-speci c 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 nd 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.

Day 1

Day One

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

Discussion session

Day 2

Day two

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

PRC

  • Health authority interactions
  • Impact of recent regulatory developments

Final discussion

  • Summary and conclusions of the seminar

Presenters

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.

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.

Book now

20-21 Nov 2019
20-21 Nov 2019 Radisson Blu Hotel, Basel, Switzerland, Basel GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
Limited places

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  • Abbott Biologicals BV
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  • Alk Abello A/S
  • BACHEM AG
  • Baxalta Innovations GmbH
  • Biogen Ltd
  • C.B. FLEET COMPANY INC
  • DEQI LAW CORPORATION
  • Engelhard Arzneimittel GmbH & Co. KG
  • Ferring Pharmaceuticals Inc
  • Galpharm International
  • Gilead Sciences International Limited
  • Gilead Sciences International Ltd
  • Grindeks JSC
  • Helsinn Healthcare SA
  • Ipsen Pharma SAS
  • LFB Biomedicaments
  • Menarini Ricerche
  • Mexichem UK Ltd
  • Nemera La Verpillière
  • Nestlé Skin Health
  • ObsEva
  • Orion Corporation Orion Pharma
  • Polpharma SA
  • SANOFI CHIMIE
  • Sanofi R&D
  • Stragen Pharma SA
  • Thomson Reuters
  • Valeant Pharma Switzerland GmbH
  • Xellia Pharmaceuticals ApS

The course was good with a lot of valuable information.

Robert Klasson, Manager Regulatory Affairs API, Xellia Pharmaceuticals ApS

Both are really great speakers.

Nermin Ipek, Global Regulatory Affairs Manager, Ferring Pharmaceuticals Inc

Excellent Speakers, helpful discussions during the sessions & coffee breaks

Thorben Bonarius, Global Head Regulatory Affairs, Siegfried AG

Very good. Speakers with great experience.

Mauro Catena, Manager, Helsinn Healthcare SA

Great

Mia Kiistala, Senior Manager, Biogen

Dynamic, knowledgeable, interesting presentations

Felicity Lyon-Staniewski, Associate Director, Biogen Ltd

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

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

Hélène Bonnans, Regulatory/Quality Manager, Sanofi Chimie

The speakers were very nice, easy to understand and available

Antoine Halais, Regulatory Expert, Nemera