TOPRA in Sweden: Regulatory Updates

TOPRA in Sweden: Regulatory Updates
This evening is an excellent opportunity to hear the latest regulatory news for medicines and medical devices. We will address the ongoing work in Europe to change the legislation for orphan drugs and for paediatric medicines. We will also hear the latest about TOPRA. Open to anyone who works with and is interested in regulatory questions for pharmaceuticals and medical devices.



Date:  31 May 2022
Time: 17:30-20:00 BST (GMT +1) / 18:30 – 21:00 CEST

Please note this is a hybrid event - Online/Uppsala (face to face).

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 English.  

Agenda


18.00 – 18.30 The evening begins with light refreshments and anniversary celebrations, for participants on site

18:30 – 18:40 Introduction
                                Vera Franzén - Vera Franzen Consulting AB

18:40 – 19:10 Regulatory news – Pharmaceuticals, for example
                               • Human Directive
                               • EU Pharma Strategy
                               • Innovation Office 
                       Åsa Kumlin Howell/Gunilla Andrew-Nielsen - Medical Products Agency

19:10 - 19:40 Regulatory news and experiences - Medical Devices, for example
                               • Experiences of MDR from a company perspective
                               • Implementation of IVDR
                               • MDCG update
                       Ann-Cathrin Jareman - Scandinavian Regulatory Services

Short break

19:55 - 20:25 New legislation for orphan drugs and for paediatric drugs
                                • Current legislation in Europe and experience
                                • Investigation and proposals for changes
                                • Looking ahead and schedule
                        Marie Gårdmark - RegSmart Life Science

20:25 – 20:35 TOPRA news
                                 Margareth Jorvid, TOPRA volunteer

20:35 - 21:00        Time for questions

Address: MPA, Dag Hammarskjölds väg 42, Uppsala or ONLINE   


Pricing

TOPRA Members: Free [MPA employees - Free. Use code MPA200]  
Non-member: £45 (includes 2 months TOPRA membership)

 

Contact us

Contact membership@topra.org or Margareth Jorvid at margareth.jorvid@lsmgroup.se,  if you want to become TOPRA member.

Questions: toprainsweden@topra.org

 

How to register

Members:

  • Use the 'Register now' form above to log in to the site with your TOPRA Member username and password.
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When
31/05/2022 17:30 - 20:00
Where
UPPSALA SWEDEN
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