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:
Benefits of attending:
�
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
P.R. China – Drug Regulatory Systems
P.R. China – Clinical Product Development
Hong Kong SAR
Macau SAR
Day 2
P.R. China – Regulatory Strategies
P.R. China – Health Authority Interactions
P.R. China – Maintenance
Taiwan (Republic of China)
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
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./ CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
KUALA LUMPUR, MALAYSIA - Media OutReach Newswire - 25 December 2024 - As the year…
Vietnam is increasingly popular among Indian tourists, consistently topping reports and surveys as a favoured…
KUALA LUMPUR, MALAYSIA - Media OutReach Newswire - 24 December 2024 - For Octa, a…
ACCRA, GHANA - Media OutReach Newswire - 24 December 2024 - 1win, in partnership with…
KUALA LUMPUR, MALAYSIA - Media OutReach Newswire - 24 December 2024 - Shopee Malaysia recently…
MOSCOW, RUSSIA - Media OutReach Newswire - 24 December 2024 - Wildberries, a leading e-commerce…