Overview
The MedTech industry is a highly regulated sector. As such, understanding how to navigate the regulatory system is a critical success factor. It is necessary to determine whether one's medical device meets the regulatory requirements and whether there is a market for the technology. By having a smart strategy in meeting the regulatory standards, you would be able to launch your product quicker into the market. In this event, we will be going through ways to solve the challenges faced by prospective MedTech companies in ensuring their products meet the regulatory standards.
Date: 10 January 2019, Thursday
Time: 5.30pm to 7.30pm
Venue: 32 Carpenter Street, Singapore 059911
Speakers' List:
- Jack Wong, Founder, ARPA (Asia Regulatory Professional Association)
- Prusothman Sina Raja, CEO & Co-Founder, Privi Medical Ptd Ltd
- Mark Chong, Senior Lecturer, Nanyang Technological University
- May Ng, Global Director, ARQon (Asia Regulatory & Quality Consultancy)
Programme Details:
5:30pm 6:00pm: Registration
6:00pm 7:00pm: Solving MedTech Regulatory Challenges and Q&A
7:00pm 7:30pm: Networking
Speakers' Profiles:
Jack Wong, Founder, Asia Regulatory Professional Association, Six Sigma Black Belt certified by IASSC
Jack Wong has over 20 years of Regulatory, Quality, Clinical Trial and Pharmacovigilance experience in Asia, and good knowledge in the field of Medical Devices, Pharmaceuticals, Nutritional, Consumer Healthcare and Biological products.
He has received awards on improving processes such as reducing the time taken to launch a product by 20%, and for helping in developing people as shown by the Watson Wyatt Survey taken by all direct reporting staff which has indicated that 100% of them are able to contribute to their fullest ability.
Externally, he has a leading role among all the Regional Regulatory professionals in Asian Harmonization Working Party (AHWP). He developed the First Asia Regulatory Affairs Certificate course since 2007, with over 2800 students from the industry, government agencies and universities. As the founder of Asia Regulatory Professional Associations (ARPA) since 2010, with over 3600 members, Jack Wong has wrote the first Asia Regulatory Book in Asia theHandbook of Medical Device Regulatory Affairs in Asia', which is on its 2nd edition as of now.
Jack is a Qualified Auditor of ISO 13485, Japanese Regulations for Medical Devices and ISO 9000 Lead Auditor by British Standards Institution.
Prusothman Sina Raja, Co-Founder, Privi Medical
Prusothman is the co-founder of Privi Medical, a medical device startup company spun out of Singapore-Stanford Biodesign (SSB). Prusothman has overseen Privi Medical's rapid progress from concept to a regulatory cleared medical device.
Apart from Privi, Prusothman has been directly involved in the development of a number of other healthcare and life sciences products. Prusothman was named a Forbes 30 Under 30 Asia for Healthcare and Science in 2017.
Prusothman also previously served as the Assistant Fellowship Head of the Singapore-Stanford Biodesign Fellowship Program. Prusothman was a 2014 Singapore-Stanford Biodesign Innovation Fellow.
Mark Chong, Senior Lecturer, Nanyang Technological University
Dr Mark Chong obtained his PhD in Bioengineering from the National University of Singapore in 2010. He then joined the National University Health System as a Research Fellow, where he was part of the team working on translational regenerative medicine projects, including clinical trials for stem cell therapeutics.
He is currently a senior lecturer in the Nanyang Technological University, where he also serves as Assistant Chair in the School of Chemical and Biomedical Engineering, facilitating talent development for the Medical Device industry.
In 2017, Mark undertook the Singapore-Stanford Biodesign Fellowship while on sabbatical, and now contributes time as co-curriulum head for Singapore Biodesign, where he develops training and reference material for MedTech Innovation in Asia.
May Ng, Global Director, ARQon (Asia Regulatory & Quality Consultancy)
May Ng is the Global Director of ARQon, Asia Regulatory & Quality Consultancy for medical devices and drugs, assisting company in product development and product registration in Asia, global approval and CE Representative. ARQon present globally with offices in Singapore, Vietnam, Malaysia, Taiwan, Switzerland and with partners worldwide.
Ms. Ng was in Singapore Health Sciences Authority (HSA) for almost 10 years to complete the implementation of the Singapore regulatory framework based on IMDRF/GHTF principles, and approving medical device/IVD. She joined Biosensors drug coated stent manufacturing in Singapore for 4 years and previous 2 years in IVD industry.
Currently, she holds role as the Advisor for the government organizations such as NHIC, ETPL, NUS and main committee in Singapore Manufacturing Federation's MedTech Industry Group, China-ASEAN Medical and the Singapore representative in the early year 1999 for the formation of AHWP and ASEAN-MDPWG for ASEAN Medical Device Directive.
