TOPRA in Sweden: Lifecycle Management

TOPRA in Sweden: Lifecycle Management
This evening is an excellent opportunity to discuss Lifecycle management for pharmaceuticals. We take up strategy for Lifecycle management, the work with Periodic Safety Update Reports (PSUR), the interesting topic of Repurposing and we get to hear experiences from the variation regulation for veterinary medicinal products as a background for upcoming changes for human medicinal products. Open to anyone working with and interested in regulatory questions.



Date:  Wednesday 14 February 2024
Time: 17:00-20:00 GMT / 18:00 – 21:00 CET
  
Please note this is a face to face presentation, conducted in Swedish.
      
Venue: Medical Products Agency, Dag Hammarskjölds väg 42, Uppsala

  

 Agenda

18.00 – 18.30 Light refreshments (sandwiches and drinks)

18:30 – 18:35 Introduction
                               Anna Mäkinen Salmi, Medical Products Agency

18:35 – 18:40 Welcome - some thoughts on the evening's theme
                        Björn Eriksson, Medical Products Agency

18:35 – 19:05 Lifecycle Management strategy – Medicines
                               • Lifecycle management strategy
                               • Patents, new indications, new formulations
                               • Important to think about
                       Eva Barkstedt, AstraZeneca

19:05 - 19:30 Periodic Safety Update Reports (PSUR)
                               • Purpose and content
                               • Regional/Global PSUR
                               • Planning for submission
                               • PSUR assessment procedure
                               • Experiences
                       Josephine Ingemarsson, Arex Advisor

Short break

19:45 - 20:10 Repurposing - authority perspective
                                • What is repurposing
                                • New legislation
                                • How are applications handled at the MPA
                                • The pilot project
                                • Experiences
                        Katarina Lönnquist, Medical Products Agency

20:10 – 20:40 Variation regulation for human/veterinary medicinal products
                                • What has changed
                                • Experiences
                                • Lessons learned that can be used for the revision of the regulation for medicinal products
                                        for human use
                                Rotana Al-Shammari, Medical Products Agency

20:40 - 21:00         Time for questions and networking



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
14/02/2024 17:30 - 20:00
Where
UPPSALA SWEDEN
Registration is closed.
My registration status: Not registered
Your company name
Your VAT country
Your VAT number
NOTE
Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

Register now