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Rama Sethuraman

Head of Quality and Regulatory, APAC Roche Diagnostics Asia Pacific Pte Ltd

Rama is the APAC Head of Quality and Regulatory in Roche Diagnostics Asia Pacific. She leads the regional quality and regulatory functions covering diagnostics and digital products, in the APAC region. Rama has over 15 years of experience in medical device quality and regulatory functions.

Prior to joining Roche, Rama was the Director, Medical Devices in the Health Sciences Authority (HSA), overseeing the pre- and post-market regulatory activities for all medical devices including medical device combination products. She represented Singapore as a member of the Management Committee of the International Medical Device Regulators Forum (IMDRF), Primary Representative for Singapore in the Global Harmonisation Working Party (GHWP) and as the head of delegation for Singapore in the ASEAN Medical Device Committee (AMDC).

Rama holds a PhD from the Faculty of Medicine, National University of Singapore (NUS). Her research focused on chronic neuropathic pain, identifying novel biomarkers related to pain and developing novel diagnostic methods using principles of chemistry in analysis of biological samples.

See Rama Sethuraman at this event

  • Day 3 Thursday 5 December

Combining strengths: Preparing regulatory systems for combination products for advanced therapies and biologics

09:00 - 10:30 CET / 19:00 - 20:30 AEDT

Session objectives:

  • Raise awareness on the current global regulatory landscape on ATMPs and Drug-Devices combination products (DDCPs).
  • Share regulatory best practices and challenges in the APEC region.
  • Discuss the need for capacity-building activities on ATMPs and DDCPs.
  • Discuss the opportunity to develop for the APEC region a cooperative network of experts and an effective roadmap for a combined approach for ATMPs and DDCPs.