Big Challenges. Need. Great People.

Miang is a Pharmacist, MBA. She has more than 25 years of regulatory affairs experience with a number of medical device manufacturers and pharmaceutical companies. Her current position at Johnson & Johnson is the  Head of  Regulatory Affairs, APJ Vision.
 

Miang has board experience in Regulatory Affairs, Clinical Research, Reimbursement, Government Affairs and Quality Assurance in Asia Pacific including Japan.
 

Prior to Johnson & Johnson, Miang worked for a number of healthcare companies (Cardinal Health, Takeda, Boston Scientific, JNJ, Actelion, Cochlear,  Bausch & Lomb, Zimmer Biomet and Alcon) in different locations (Bangkok, Hong Kong, Sydney and Singapore).
 

In addition to her current job, she has been heavily involved with several harmonisation activities including GHTF, AHWP, APEC RHSC and ACCSQ. She was one of the members of GHTF SG02 (Postmarket Surveillance) and Co-chair of AHWP TC 2 terms.
 

Currently, she is a chair of APACMED Regulatory Affairs group and an industry secretariat of AHWP TC.

Iwasaki has over a decade of experience in the field of regulatory affairs of medical device. He started his career in Terumo Corporation Japan, and managed product registrations in not only Japan but also Asian countries including China for several years. In Japan, he also experienced to get premium reimbursement for an innovative medical device.

After that, he started to work as an area manager of regulatory affairs and quality assurance in Asia region. He is now handling any RA/QA matters there, and also a member of international committee of Medical Technology Association of Japan.

Yiting has over 14 years of experience in the medical technology field in industry and government. He is currently the APAC Regional Regulatory Affairs Director at Alcon. 

Yiting is actively involved in regional harmonization work and was a member of various Work Groups in AHWP and APACMed. In addition to his role as working member of these harmonisation groups, he is also a speaker in several editions of ASEAN Medical Device Committee Meeting (AMDC) and AHWP Annual Training Workshops, with topics ranging from Post-market Surveillance, Pre-market Registration and Artificial Intelligence Medical Devices. 

Yiting currently serves as an instructor for the Graduate Certificate in Medical Device Regulatory Affairs (GCMDRA) by National University of Singapore, covering topics from Pre to Postmarket as well as country regulations (US, EU, China, ASEAN etc.)