We are delighted to see your interest in Freyr Webinar Series (FWS). The webinar on “Medical Devices in the UK & UKRP: Latest Industry Updates” is scheduled on October 27, 2021, for AMR, EUA & ROW regions.
What Is It All About?
Following the first two grace periods for registering medical devices with the UK MHRA since post-Brexit elapsed, the medical device industry is now moving towards the third MHRA grace period due on December 31, 2021. Most medical devices and IVDs are expected to fall under the third grace period, and a huge influx of applications are anticipated for the UK MHRA. Since the end of the Brexit transition period on January 1, 2021, there have been significant updates published by the UK MHRA. However, there are many unpublished updates at the submission, approval stage, and post-registration activities. As a medical device and IVD manufacturer exporting to the UK, are you aware of these details?
To help you understand the current practical considerations of the UK device registrations and UKRP, we bring you an exclusive webinar on:
Medical Devices in the UK & UKRP: Latest Industry Updates
October 27, 2021
Duration – 45 Minutes
Join the Webinar at your Convenient Time
(For AMR and EUA Regions)
2:30 AM EDT | 4:00 PM CEST
(For RoW Region)
1:30 PM IST
Host
Igor Dorosh
Associate Director, Business Development – Europe & Africa
Igor Dorosh comes with eight (08) years of experience in the 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 Associate Director, Business Development - Europe & Africa, and is driving business development ventures.
Presenter
Nisha Vempalle
Director - Medical Devices
Nisha Vempalle leads medical devices Regulatory operations in the UK and EU in Regulatory readiness, strategic planning, and spearheads project delivery. 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 of medical devices. Her core strength is the deep understanding of the medical device Regulatory landscape in the 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 master's degree in Pharmaceutical sciences from Kingston University, and is a RAC-EU & global certified professional.
In this webinar, our in-house Regulatory expert, Nisha Vempalle, Director - Medical Devices, will elaborate on:
- Introduction to Regulatory Landscape in the UK
- Overview of the MHRA Registration Timelines
- MHRA Regulatory Updates Post September 1, 2021, Timeline
- Import Obligations of UKRP
- Do You Need Importer/Distributor?
- Do’s and Don’ts for a UKRP
- Certificate of Free Sales for non-UK manufacturers
- Post Registration Activities for Manufacturers & UKRP
- UKRP Challenges from Practical Scenarios
- Success Stories/Case Studies
Given the keynotes and with due respect to your busy schedule, we look forward to seeing you in the webinar. Register now! Stay informed. Stay compliant.