This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

MedTech Summit
10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)

Asha Jacob
Senior Manager Regulatory Affairs & Compliance at Philips
Speaker

Profile

I am a Regulatory Affairs and Compliance professional, and have a background spanning 11 years in the MedTech and Pharma industries, complemented by 12 years of experience in Research & Development for in-vitro devices and pharmaceuticals. My expertise encompasses various domains, including Technical Documentations, Regulatory Affairs, Clinical Affairs, Medical Writing, and Quality Assurance. Currently, I am Senior Manager and Head of Regulatory Affairs and Compliance Team, Philips Medical Systems, the Netherlands. I am also EU Authorised Representative (AR) Officer and Person Responsible for Regulatory Compliance -2 at the EU AR Office in Philips. In these roles I have designed, implemented, and managed a Philips-wide Assessment and Improvement Program for its Technical and Clinical Documentations in compliance to EU MDR (2017/745).


Agenda Sessions

  • Supporting Indirect Clinical Benefits in Clinical Evaluations

    11:55
  • Harvesting and Using Real-World Evidence (RWE) for Devices & Diagnostics

    14:15