A/Prof Jack Wong has over 20 years of experience in regulatory, quality, clinical trial and pharmacovigilance in Asia, for medical devices, pharmaceuticals, nutritional, consumer healthcare and biological products. He has received awards on improving processes, including reducing 20% of time required for a product launch, and grooming people to contribute to their fullest ability.
A/Prof Wong plays a leading role among all the regional regulatory professionals in the Asian Harmonisation Working Party (AHWP). He has developed the first Asia Regulatory Affairs Certificate course, which has been held since 2007 with over 2800 students from the industry, government and universities. A/Prof Wong is the founder of ARPA, which was established in 2010 with over 3600 members to date. He also wrote the first Asian regulatory book, ”Handbook of Medical Device Regulatory Affairs in Asia: Second Edition”.
A/Prof Wong has a Six Sigma Black Belt certified by International Association For Six Sigma Certification (IASSC); the license as a Qualified Auditor of ISO 13485, Japanese Regulations for Medical Devices; and qualifications as an ISO 9000 Lead Auditor by British Standards Institution (BSI).
Over 18 years of clinical trial, regulatory and vigilance experience in Asia for medical devices, pharmaceuticals, nutritionals, consumer healthcare, and biological products. More than 15 years of experience as Director of Regulatory Affairs, Asia Pacific at various global pharmaceutical and medical device multinational companies.
Current secretariat for the Asian Harmonisation Working Party (AHWP), and an active member in ASEAN, APEC, ISO, and WHO projects. Developed the First Asia Regulatory Affairs Certificate course in 2007, which has since had 2800 students in the alumni.
Founder of Asia Regulatory Professional Association (ARPA) since 2010 with more than 3600 members and Asia GRP (Good Regulatory Practice) Research Centre since 2011.
- Healthcare - Test & Verification/Clinical Trials, Certification/Regulatory Compliance