Course overview
Unlock the complexities of Asian pharmaceutical markets with our comprehensive three-day programme on Pharmaceutical Regulatory Affairs. Designed for professionals seeking a deeper understanding of regional regulatory frameworks, this expert-led course will equip you with the essential knowledge to successfully navigate the diverse and evolving requirements across Asia.
This course offers in-depth coverage of key Asian markets, including China, India, and Korea, providing participants with a clear roadmap for regulatory compliance. It also explores the ASEAN region, featuring Brunei, Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam.
As part of the broader context, the programme includes a brief comparison with Japan to highlight distinctions, although more detailed information is best explored through dedicated courses.
Throughout the three days, you’ll gain critical insights into regulatory pathways, market entry requirements, and the role of clinical trials where applicable, particularly as prerequisites for product registration. In addition, the programme addresses Pharmaceutical Maintenance and a range of other essential regulatory considerations, with a strong emphasis on innovative products and extensive reference to generic pharmaceuticals.
Don’t miss this opportunity to deepen your regulatory expertise and position yourself for success in Asia’s fast-growing pharmaceutical landscape. Reserve your spot today and take the next step in your professional development.
Looking for an in-depth course on Greater China? Don’t miss our comprehensive session on Pharmaceutical Regulatory Affairs in China.
CPD Hours: 18
Course Content
- Day 1
- Introduction to the Asia Region
- Introduction to ASEAN
- Quiz
- Philippines
- Brunei
- P.R. of China overview
- Hong Kong SAR overview
- Day 2
- India
- Malaysia
- Singapore
- Thailand
- Indonesia
- Vietnam
- Quick outlook: Cambodia and Laos
- Day 3
- Taiwan overview
- Korea
- Outline on Japan
- ASEAN Harmonisation
Speakers
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.
