Handbook of Medical Device Regulatory Affairs in Asia

Abstract

Preface on regulatory knowledge needs ARPA - Prof Jack Wong (ARPA - Asia Regulatory Professional Association) How to train University students with regulatory - Prof Raymond Tong (HKPU - Hong Kong Polytechnic University) Part 1 : Introduction How to be a good regulatory staff - Minnie Baylor-Henry How regulatory staff works with marketing and supply chain team to ensure smooth product launch - Mr Alok Mishra Do the right thing - Prof Jack Wong (ARPA - Asia Regulatory Professional Association) Access of medical device in developing countries - Rosanna Peeling (University of London) and Tikki Pang (WHO - World Health Organization) Soft Skills a story of attention - Richard Liu Account Manager MCI Part 2: Medical device safety and related ISO Standards Medical Device History - Dr Bill Wong (MIT - Massachusetts Institute of Technology) Labeling: why it is so important- Jaap Laufer MD, PharmD Global Head, Regulatory Affairs, DEKRA Certification B.V. Evangeline D. Loh, PhD, Director Regualtory Affairs, Emergogroup Inc Clinical Trials: Legal and Ethical Considerations of Increasing Globalization - Paula Celine Trepman, Undergraduate student and researcher, Massachusetts Institute of Technology Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific - Geraldine Seow Medical Device Classification Guide - Patricia Teysseyre ISO 13485 - Gert Bos (BSI - British Standard Institute) ISO 14971 - Prof Raymond Tong and Prof Tony Chan Part 3: Harmonization of Medical Device in Asia WHO - Adriana Peeling (WHO) AHWP - AHWP chair- Saudi Arabia APEC - Ms. Lindsay Tao ASEAN - Ms. Petahn McKenna RAPS - Sherry Keramidas Expediting Innovation in Singapore with Regulatory Knowledge Patricia Ho and Dr. Jui Lim Singapore Stanford Biodesign Part 4: US and EU Regulatory system US - Ms Carole Carey (US FDA - Food and Drug Administration) EU - Ms. Patricia Teysseyre Combination product regulatory in US - John Barlow Weiner (US FDA - Food and Drug Administration) Combination product regulatory in UK - Janine Jamieson (UK MHRA - Medicines and Healthcare products Regulatory Agency) Part 5: Regulation in Asia-Pacific Countries Australia - Ms. Petahn McKenna China - Mr Wang Boating (China SFDA), Dr Zheng YiMan, Ms Carol Yan Hong Kong - Prof Jack Wong India - Dr Saini Kulwant Indonesia - Ms. Mita Rosalina Japan - Dr Atsushi Tamura (PMDA - Pharmaceuticals and Medical Devices Agency) Jordan - Anan Abu Hassan (Jordan FDA) Korea - Mr Lee (KTL - Korean Testing Laboratories), Ms. Hwang Sun Bin Malaysia - Ms. Ong YeanTing Philippines - Jennifer Cheah, Mary-Claire Cacanindin Saudi Arabia - Ali M. Al Dalaan (Saudi FDA- Saudi Arabia Food and Drug Administration) Singapore - Ms. Lee Ching Hwee Taiwan - Ms Liu Li Ling (TaiwanFDA - Taiwan Food and Drug Administration) Thailand - Jennifer Cheah, Eiamsukawat, Swairin United Arab Emirates - Dr. Amin Hussain Al Amiri (Ministry of Health - Abu Dhabi) Vietnam - Mr Tuan and Ms. Thuy Nguyen Thi Thu