We are delighted to see your interest in Freyr’s Webinar Series (FWS). The webinar on, Post Brexit Scenario for Medical Devices: Appointing a UKRP”, is scheduled on April 21, 2021, for AMR, EU & ROW regions.

What Is It All About?

It is well known that from Jan 1, 2021, medical devices to be placed on the UK market are obliged to follow a new Regulatory regime. Medical device manufacturers who are placed outside the UK and are willing to enter the UK market, shall appoint a UKRP (United Kingdom Responsible Person), who can in turn act on behalf of the non-UK manufacturers and take on the Regulatory responsibilities, as per the MHRA guidelines to successfully register and launch the devices in the UK. Who is a UKRP? What are his roles and responsibilities and how is he appointed? When should a device manufacturer appoint a UKRP? What are the routes to market the medical devices in Britain and Northern Ireland?

To gain comprehensive insights on UKRP, Freyr brings you an exclusive webinar on:

Post Brexit Scenario for Medical Devices: Appointing a UKRP

April 21, 2021

Duration - 45 Minutes

Join the Webinar at your Convenient Time

For AMR and EU Regions

10:00 AM EDT | 4:00 PM CEST

For RoW Regions

11:30 AM IST

Host

Igor Dorosh

Associate Director,  Business Development - Europe & Africa

Igor Dorosh comes with 8 years of experience in Pharmaceutical industry. He is a strong sales professional, skilled in market access analysis, Regulatory affairs & pharmacovigilance outsourcing optimization for the EU and emerging markets. Igor is currently working with Freyr Solutions as Sr. Sales Manager – Europe & Africa and is driving business development ventures.

Presenter

Nisha Vempalle

Director, Medical Devices

Nisha Vempalle leads Medical Devices Regulatory operations in UK and EU in Regulatory Readiness, Strategic planning and being Project delivery spearhead. She has more than 15 years of experience across Regulatory Affairs-delivering Global Innovation Projects, Regulatory strategies, leading Regulatory Projects to successful approvals and launch in Medical Devices. Her core strength is the deep understanding of Medical Device Regulatory landscape in UK and EU regions apart from her International expertise including Asia, Africa, Middle East and South America. She has a wealth of experience from her previous roles at PAGB, GlaxoSmithKline and Biocon spanning more than a decade. Nisha is a Pharmacist and holds a masters degree in Pharmaceutical sciences from Kingston University and is a RAC-EU & Global certified professional.

In this webinar, our in-house Regulatory experts – Nisha Vempalle, Director of Medical Devices and Igor Dorosh, Senior Manager- EUA New Business Development (EUA – NBD), will elaborate on:

  • Overview of the UK Medical Devices Market
  • Overview of the MHRA
  • Routes to Market the Medical Devices in Britain and Norther Ireland (NI)
  • Who is a UKRP?
  • Roles and Responsibilities of a UKRP
  • Solutioning Models

Given the keynotes and with due respect to your busy schedule, we really look forward to seeing you in the webinar. Register now! Stay informed. Stay compliant.