About the Speakers:

Dr Michael Ewing 

Data Science Lead,

Arcondis Group

Talk Title:

Best Practices in Data Management – Balancing Data-Driven with Compliance-Driven Data Requirements

Biography:

Michael spent over twenty years in academic research at the intersection of mathematics and statistics, analytical and physical chemistry, and neuroscience and molecular biology developing methods and biochemical instrumentation that resulted in the award of several patents. Interspersed with and following his academic career, he worked co-founded and directed several startups in biochemical and biomedical instrumentation and in social media and social health as a scientist and data and analytics lead. In 2020, Michael moved to Arcondis where he is the Lead for Data Science and related services and consults with several clients on topics ranging from Data Management to Data Strategy to Advanced Analytics.

Dr Karthik Seetharaman

Senior Product Manager, Data4Life

Talk Title:

Healthcare data management and security – Stories from collaborations

Biography

Dr. Karthik Seetharaman is an experienced professional with more than a decade of international experience in research, development, project management, and product management in healthcare and medical devices development. He has worked with universities, startups, and established organisations to successfully launch products that have created a positive impact in healthcare.

Dr. Karthik obtained his PhD in Neuroengineering from NTU. He is currently the Sr. Product Manager of the Analytics Platform at Data4Life, a non-for-profit initiative.

In his spare time, he likes to do film photography and cook. Also, he enjoys figuring out how he could improve the products around his house much to the annoyance of his family. 

Specialties: Neuro-engineering, Sports Engineering, Biomechanics, Medical Devices, Healthcare, Product Management, Project Management, Digital Health, Digital Transformation, Wearables, Tele-health, Psychophysics, Data Science

 

Ms May Ng

Global Regulatory Director, ARQon (Asia Regulatory & Quality Consultancy For Medical Device & Drug)

Talk Title:

E-health software and AI: Regulatory landscape

Biography

May had her start in the In-Vitro Diagnostics (IVDs) industry since 1990s. Within a decade of work with the Health Sciences Authority (HSA) in Singapore, she played a key role in establishing the medical devices branch and also, the local and regional medical device guidance. Subsequently, she became the Regulatory Director at Biosensors International Group, a manufacturer of interventional cardiology drug-device products for a number of years before setting up ARQon. May also the Regulatory and Quality Director in Endofotonics, a start-up manufacturer for In vivo Molecular Diagnostic (IMDx).

Her experience in the design and manufacturing sites as well as in the commercial industry and as the local regulator enables her to guide all relevant departments during the entire product life cycle on the regulatory strategy and documentation to meet the global registration requirements and compliance.

  • Regulatory compliance from product design, manufacturing and distribution

(DHF/DD/TF, Clinical trial, Customs, Labelling, Product changes, Recall)

  • Technical documentation & Site compliance from regulator audit

(EU DEKRA, TUV SUD, KR MFDS, AU TGA, JP PMDA, BZ ANVISA, SG HSA) 

Top Top