Date: 16 November 2021
Time: 17:30-20:00 GMT / 18:30 – 21:00 CEST
Open to anyone who works with and is interested in regulatory questions for pharmaceuticals and medical devices.
The meeting is planned at the Medical Products Agency (limited number) and Online due to covid-19, and will follow at the time of the meeting current recommendations from the Public Health Agency of Sweden
This presentation will be conducted in Swedish.
18:30 – 18:35 Introduction
Margareth Jorvid - Methra Uppsala AB, LSM group
18.35 – 18.40 MPA and Medical Devices
Björn Eriksson - Medical Products Agency, Uppsala
18.40 – 18.55 EU Commission perspective
Background and Objective
From planning to reality
Erik Hansson - Senior Advisor to the European Commission
18:55 – 19:25 IVDR work from the MPA's perspective
Status within the EU work
Ola Philipson - Medical Products Agency
19:35 – 20:05 How does IVDR change the work at the company
Planning / preparation
Classification of products
Post market surveillance
Ann-Cathrin Jareman / Elinor Nicolaou - Scandinavian Regulatory Services
20:05 – 20:35 Clinical performance studies of IVD products
Application procedures pending EUDAMED
Safety Reporting Procedures
Elin Karlberg - Medical Products Agency
20:35 - 21:00 Time for questions
TOPRA Members: Free [MPA employees - Free. Use code MPA200]
Non-member: £45 (includes 2 months TOPRA membership)
Contact email@example.com or Margareth Jorvid at firstname.lastname@example.org, if you want to become TOPRA member.
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