Dynamic Learning Experience

Marianne brings a twenty year background in regulatory affairs to Alcon, serving in both the medical device industry and government.
As Alcon’s Head for Regulatory and Government Affairs for the Asia Pacific (inclusive of China and Japan) regions, Marianne drives the implementation of the Company’s global quality, regulatory and government affairs strategy for development and marketed products within the region to deliver timely approvals to facilitate successful market launch for innovative products.
 

She remains deeply engaged in the various medical device regulatory workstreams, namely the Asia Pacific Medical Technology Association (APACMed), in which she serves as Capacity Building Working Group Vice-Chairperson. She is also a seasoned trainer to Government Agencies for capacity building and is an appointed instructor for the Graduate and Advanced Certificate for Medical Devices Regulatory Affairs Programmes from the National University of Singapore.

Marianne started her career with the Health Sciences Authority and was part of the team that drafted and implemented the Singapore Medical Device Regulations and introduced the ASEAN CSDT for registering medical devices. She was also the Head-of-Delegation (HoD) in the ASEAN Medical Device Product Working Group (MDPWG), which is the regulators’ forum on reducing Technical Barriers to Trade for medical devices.

Marianne holds a Master of Science in Bioengineering from Nanyang Technological University of Singapore and a Bachelor of Science (Hons) majoring in Pharmacology from the National University of Singapore

Dr Adelheid Schneider earned her Doctor of Science in cell biology and immunology from the University of Hohenheim/Germany and the Fraunhofer-Institute for Surface Technology.

With a background of biotechnology and cell biology Adelheid joined Roche in 1995. Within Roche, she worked in the field of research and development in protein chemistry and enzymology, quality assurance, quality control, documentation and regulatory affairs operation and policy.

Before Adelheid retired and became an Independent Consultant, she was based in Singapore as Regional Head for Regulatory and Quality for Roche Diagnostics and had oversight of all outreach activities with global health authorities, industry associations and scientific organisations.  

Dr. Schneider has 

Dr. Schneider was the Vice Chair of APAC Med Regulatory Affairs Committee and Sponsor of Capacity Building and IVD working group. She was also an active member of APAC Med Regulatory Intelligence Group and the SEA Center of Excellence group. .

Dr. Schneider was appointed as Visiting Expert of the Duke Core Centre of Regulatory Excellence. Additionally she was leading several projects in the AHWP/GHWP IVD working group 2

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.

Varun Veigas is the leader – Policy and Strategic Partnerships, Asia pacific, Roche Diagnostics, located in Singapore.  A market access, health policy and regulatory policy specialist with passion for digital health with extensive experience in medical devices, in-vitro diagnostics, pharmaceuticals, biologicals and vaccines.

Varun’s role encompasses contriving  policy strategy development based on therapeutic scientific knowledge, digital innovations, market needs and stakeholder insights to advocate for health systems, access and regulatory policy initiatives especially in areas related to IVDs and digital health solutions such as SaMD, clinical decision support, SaMD systems based on artificial intelligence / machine learning. 

Varun interfaces with ministries of health, government institutions, HTA bodies, regulatory bodies, industry associations, and other key stakeholders for Roche Diagnostics in the Asia Pacific region.

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.)