Course overview
This two-day webinar offers a comprehensive review of Pharmaceutical Regulatory Affairs in China. It provides participants with the essential knowledge and understanding of the regulatory requirements for conducting clinical trials in the People’s Republic of China (PRC) and for registering pharmaceutical products for the Chinese market.
While the primary focus is on the PRC, the webinar also covers regulatory frameworks in Hong Kong (Special Administrative Region), with brief insights into Macau. Detailed information is provided regarding the registration of pharmaceutical products in both PRC and Taiwan (Republic of China, ROC).
This course also examines pharmaceutical maintenance and other regulatory matters, primarily focusing on innovative products, while including relevant information about generic products.
The programme combines real-world case studies with practical guidance, drawing from the speaker’s own professional experience to explore theoretical scenarios. Participants are encouraged to enrich the discussion by sharing relevant company insights, where appropriate and permitted
Please note: This webinar does not cover Medical Devices, Immunology drugs, or Vaccines.
CPD Hours: 12
Course Content
- Day 1
- Presentation of participants
- Quiz
- Drug regulatory systems
- Clinical product development
- Hong Kong
- Macau
- Day 2
- Product registration strategies
- Case studies
- Variations
- HA Interactions
- TAIWAN Republic of China
- Recent developments
- Q&A and quiz
Speakers
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.
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.
