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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.

★★★★★ "The speakers were very professional, detailed in providing information and they promoted interaction... more"

17-18 Apr 2023
+ 2 more dates

Need help? Enrol or reserve

Format: Live online, Classroom
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

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 or reserve

The Pharmaceutical Regulatory Affairs in China course will cover:

Day 1
Day 2

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 or reserve

Monica Dressler-Meyer
Pharma International

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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.

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Alan Chalmers
Pharma International

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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.

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Book Pharmaceutical Regulatory Affairs in China Live online/Classroom training

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

17-18 Apr 2023

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 12177

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 13 Mar

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

View basket

Not ready to book yet?

for 7 days, no obligation

13-14 Jul 2023

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 12723

GBP 1,299 1,499
EUR 1,869 2,149
USD 2,137 2,449

Until 08 Jun

2 days classroom-based training
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

12-13 Dec 2023

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 12433

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 07 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

View basket

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.

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

I would highly recommend

Nov 22 2022

Maria Mikkelsen Denmark
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 Italy
Regulatory Affairs Officer, Menarini Ricerche Spa

Nov 25 2020

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

Nadège Caminet Switzerland
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 Ireland
Regulatory Affairs Manager , Recordati Ireland

Nov 20 2019

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

Julia Strack Germany
Manager Regulatory Affairs, Cheplapharm Arzneimittel GmbH

Nov 20 2019

Super programme, super speakers!

Lu Dao Germany
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 Switzerland
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 Switzerland
Debiopharm Research & Manufacturing SA

Nov 27 2018

Excellent Speakers, helpful discussions during the sessions & coffee breaks

Thorben Bonarius Switzerland
Global Head Regulatory Affairs, Siegfried AG

Nov 27 2018

The course was good with a lot of valuable information.

Robert Klasson Denmark
Manager Regulatory Affairs API, Xellia Pharmaceuticals ApS

Nov 27 2018

Both are really great speakers.

Nermin Ipek Denmark
Global Regulatory Affairs Manager, Ferring Pharmaceuticals Inc

Nov 27 2018

Very good. Speakers with great experience.

Mauro Catena Switzerland
Manager, Helsinn Healthcare SA

Nov 21 2017

Great

Mia Kiistala United States of America
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 United Kingdom
Medical Regulatory Manager, Mexichem UK Ltd