DUBLIN–(BUSINESS WIRE)–The “Pharmaceutical Regulatory Affairs in China Training Course” conference has been added to ResearchAndMarkets.com’s offering.
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.
Key Topics Covered:
Day 1
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 includingCMC
- Regulatory requirements includingGCPaspects
- 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
Day 2
P.R. China – Regulatory Strategies
P.R. China – Health Authority Interactions
P.R. China – Maintenance
Taiwan (Republic of China)
- Cultural background
- Regulatory authorities
- Regulations and guidelines
- Drug classification systems
- Data requirements
- Country-specific matters
P.R China – Recent Developments
Speakers:
Monica Dressler-Meyer
DRA Manager
Management Forum
Mónica 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.
Alan Chalmers
Pharmacist
Management Forum
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.
For more information about this conference visit https://www.researchandmarkets.com/r/584jb2
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