The pharmaceutical market in Asia is growing at a rapid pace and presents both opportunities and challenges to those wishing to work in the region. Rather than a single market, Asia is a collection of different markets, each with their own regulatory processes, although harmonisation exists within the ASEAN countries.
This seminar will provide a practical overview of the key areas of pharmaceutical regulatory affairs in Asia, including India, and will cover all important aspects of gaining and maintaining a successful marketing authorisation within the region.
The programme will include:
- Discussion of underlying official regulatory sources
- An interpretation of practical aspects
- An overview of the requirements for local manufacturing
- Recent developments
- Harmonisation initiatives
- An update and wider knowledge of regulatory affairs in Asia
- The opportunity to exchange experiences with other delegate
Benefits of attending:
- Gain an overview of key Asian markets
- Discuss outlines of company and product registration
- Understand the application process
- Assess the impact of recent regulatory developments in the region
- Discuss harmonisation initiatives including ASEAN opportunities
- Understand how Japan fits in the Asian regulatory landscape
- Discover general, country-specific and regional requirements
Please note that the course will provide an excellent introduction to all the key aspects of regulatory affairs in the Asia region but will not focus specifically or in detail on Chemistry, Manufacture and Control (CMC).
Certifications:
- CPD: 18 hours for your records
- Certificate of completion
Speakers
Ms Monica Dressler-Meyer,
DRA Manager ,
Management ForumMónica is DRA Manager based in Switzerland with several 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. Mónica has a Degree in Chemistry and Biochemistry from Basel University.
Dr Alan Chalmers,
Pharmacist ,
Management ForumDr 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.
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, whether as an introductory or a refresher course.
Previous delegates have included:
- Scientists and technical staff in
- Regulatory affairs
- Registration departments
- Medical directors
Programme
The programme consists of regional presentations covering:
- The markets
- Brief commercial and cultural background
- Importance of major markets
- Company and product registration
- Regulations and guidelines
- Drug classification systems
- Site registration
- New products
- Line extensions
- Labelling changes
- Sourcing changes
- Registration samples
- Certificates/legalisation
- Application process
- Committees/meetings
- New applications
- Variations
- Renewals/re-registration
- Recent regulatory developments
- Influences and changes: national and regional
- The latest regulatory developments in the region
