Gain practical advice on how regulations are being applied to enable you to take full advantage of this rapidly growing market.
Now that the European medical device market is well established, the next growth area is Asia-Pacific. China, together with other countries in this region, have all implemented, or are in the process of implementing, their own medical device regulations. This seminar will provide a comprehensive overview of the medical device regulations and developments in China together with other newly regulated markets such as India, Hong Kong and Singapore. Practical guidance on how to comply with the requirements and gain access to these growing markets will be given.
Discover how these requirements are being interpreted and applied and how to maximise on this rapidly growing market.
Benefits in Attending:
09.00 Registration and coffee
09.30 Course starts
Overview by ChairOverview of medical device markets in Asia
Update on the Asia Harmonization Working Party (AHWP) & ASEAN
New medical device regulations in China
Current medical device clinical trial requirements in China
Medical device law (PMDL) in Japan
17.00 Course finishes
09.00 Course starts
Review of day one
Newly Regulated Markets: Korea and Taiwan*
Newly Regulated Markets: Hong Kong
Newly Regulated Markets: Malaysia and Singapore
Newly Regulated Markets: Indonesia and Thailand
Adverse Event Reporting Systems in Asia
Delegates Questions and Answers Session
15.45 Course finishes
Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, he worked in clinical and academic medicine before spending 20 years as a senior regulator for both medicines and medical devices.
He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA and joint CEO of the MHRA. He was involved in the establishment of the European Medicines Agency, is a CPMP/CHMP member and Chair of the MRFG and PER scheme. For the last ten years he has worked in industry and chairs several key committees for ABPI,EFPIA and IFPMA.
We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
See below or contact us to discuss yor requirements.
United States of America