TOPRA in Sweden: Revision of EU Pharmaceutical Legislation

TOPRA in Sweden: Revision of EU Pharmaceutical Legislation
TOPRA in Sweden invites you to a presentation on the Regulatory Update of Medicinal Products/Medical Devices - Revision of EU Pharmaceutical Legislation.



  


Date:  Monday 16 October 2023
Time: 17:00-20:00 BST / 18:00 – 21:00 CEST  
 
Please note this is a face to face presentation, conducted in Swedish.
      
Venue: Medical Products Agency, Dag Hammarskjölds Väg 42, Uppsala, Sweden

This evening is an excellent opportunity to hear the latest regulatory news for pharmaceuticals and medical devices. We address the ongoing work on revising pharmaceutical legislation within Europe. On 26 April 2023, the EU Commission adopted a proposal for a new directive and a new regulation, revising and replacing the existing general pharmaceutical legislation. We also get to hear the latest about TOPRA. Open to anyone working with and interested in regulatory issues for pharmaceuticals and medical devices.

The meeting, which normally takes place in May each year, has been moved to October in order not to collide with the intensive half-year for Sweden’s Presidency within EU.
  

 Agenda

18.00 – 18.30 Light refreshments (sandwiches and drinks)

18:30 – 18:35 Introduction
                                Marina Stenlander, BMS

18:35 – 19:05 Regulatory news - Medicines:
                                • Experiences from Sweden's six months Presidency
                                • Latest news from the EU Commission
                                • Management of drug shortages
Åsa Kumlin Howell, Medical Products Agency

19:05 - 19:25  Regulatory news - Medical Devices
                               • How does LV work with medical devices
                               • Experience with MDR and IVDR
                               • Ongoing EU work (MDCG etc)
Ola Philipson/Sandra Brolin, Medical Products Agency

Short break

19:40 - 20:05 Revision of EU legislation for medicinal products
                               • Current legislation in Europe and experiences
                               • Proposals for changes
                               • Looking ahead and timetable
                       Åsa Kumlin Howell, Medical Products Agency

20:05 – 20:30 New EU legislation for pharmaceuticals from an industry perspective
                               • How does the proposal affect the companies
                               • How does industry participate in the change work
                               • Looking ahead
                                Linda Melkersson, LIF 

20:30 – 20:40       TOPRA news 
                       Margareth Jorvid, TOPRA volunteer

20:40 - 21:00 Time for questions
 

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.
  • Once logged in click the 'Register Myself' button that will appear below.

Non-members:

  • If you already have non-member account for this site, log in and then click the 'Register Myself' link that will appear below.
  • If you do not have an account, create an account, then log in and click the 'Register Myself' link that will appear below.

Any questions, contact: toprainsweden@topra.org.

 
When
16/10/2023 17:00 - 20:00
Where
Medical Products Agency Dag Hammarskjölds Väg 42 UPPSALA SWEDEN
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