Webinar: Evolving Regulatory Landscape for In Vitro Diagnostics (IVD) in APAC

Thursday, June 8, 2023 |
2 PM SGT, 4 PM AEST, 11.30 AM IST
In partnership with APACMed

The Asia Pacific Medical Technology Association (APACMed) represents manufacturers and suppliers of medical equipment, devices and in-vitro diagnostics, industry associations and other key stakeholders associated with the medical technology industry in Asia Pacific. As a trade association, our mission is to improve the standards of care for patients through innovative collaborations among stakeholders to jointly shape the future of healthcare in Asia Pacific.

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The Evolving Regulatory Landscape for In Vitro Diagnostics (IVD) in the Asia-Pacific (APAC) region is an important and rapidly developing topic that is of interest to healthcare professionals, regulatory authorities, and IVD manufacturers.

This webinar will focus on the key issues and challenges facing the IVD industry in the APAC region, including the impact of new regulations, the importance of speed to market, connectivity and data integrity, extended approvals, and AI and software regulation.


 

Topics covered:

  • The impact of changes in European regulations on the IVD industry in the APAC region
  • The importance of speed to market in APAC countries
  • How regulations can drive the development of certain IVD product types
  • Connectivity, integrity and data in the IVD industry in APAC
  • The use of data from existing products or tests to obtain extended approvals for new IVD products
  • AI and software regulation in the APAC region

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Speakers:

Ms. Huang Yasha
Head Regulatory Policy (APAC), Roche Diagnostics

Yasha has extensive experiences in health policy and she is passionate about advocating for regulatory science as well as enhancing holistic capacity building for regulatory professionals. Prior to Roche, Yasha was most recently the Regulatory Affairs Director at APACMed. Her main role was driving regulatory initiatives for patients’ better access to medical technologies, by leading the Regulatory Affairs Committee and collaborating with key stakeholders including government agencies, local associations, regulatory harmonization and convergence platforms, such as IMDRF, AHWP, APEC RHSC, etc. 

She is currently the Chairperson of IVD Regulatory Group and Vice Chair of Digital Health Regulatory Group at APACMed. 

Mr. Victor Tan
QA & RA Manager - ASEAN, Ortho Clinical Diagnostics​

Victor is a QARA Professional with more than 10 years of experience in managing quality and regulatory affairs in the Medical Devices / In Vitro Diagnostics (IVD) space. 

Currently, he is the QA & RA Manager of Ortho Clinical Diagnostics for the ASEAN region. He is also serving as the Management Representative for the company's ISO13485:2016 certification in Singapore.

He holds a graduate certificate in Medical Device Regulatory Affairs (NUS) and is also a certified lead auditor (ISO13485:2016) and certified quality manager (American Society of Quality).

Mr. Sam Kay
Principle Regulatory Consultant, Clarivate

Sam is a Principle Regulatory Consultant specializing in regulatory intelligence. Sam Joined Clarivate after holding multiple roles in regulatory intelligence and strategy across multiple large and small pharma and med-tech companies.

Sam’s main goal is to bring regulatory affairs into a more strategic focus through high-quality intelligence across the industry, enabling rapid access to life-saving medicines and medical devices across the globe.

Mr. Raghav Tangri
Lead Healthcare Analyst (Medtech), Clarivate

Raghav is a lead healthcare analyst with Clarivate's medtech division and is a thought leader in the space. He has been supporting business decisions in the domain through data analysis and insight generation, business and competitive intelligence, and forecasting for nearly 7 years.

He is an expert in creating bottom-up (epidemiology/procedure-based) and top-down (financial-based) forecast models for multiple device markets globally. He has also led the analysis of the impact and recovery trends of COVID-19 for medtech markets internally at Clarivate as well as for the clients of Clarivate.