TOPRA in Sweden: Combination Products

TOPRA in Sweden: Combination Products
Development of combination products or when drugs and medical devices and/or in vitro medical devices are combined, have its own special challenges. An EU common regulation 536/2014 (also called Clinical Trials Regulation, CTR) applies to clinical trials of medicinal products for humans. A single application for the drug is sent to an EU-wide web portal and database (CTIS) and results, after an EU-wide investigation process, in a national decision. For a combined clinical investigation, the medical device or in vitro medical device must be applied for and approved nationally using different processes in different EU countries. We will hear how different combination products are handled to regulatory approval, about COMBINE, a project to facilitate combined studies, about what rules and guidelines exist and practical experiences. We also get to hear some news about TOPRA. You get the opportunity to meet colleagues in a relaxed and pleasant environment. The meeting is open to anyone who works with and is interested in regulatory affairs.


Please note this is a face to face presentation, conducted in English.
       

Agenda

18:00 – 18:30      The evening begins with light refreshments
  
18:30 – 18:35      Welcome
                                     Speaker Ruxandra Ionescu, TOPRA volunteer            

18:35 – 19:05     Introduction to Combination Products
                                    - Overview of drug-device combination products in Europe
                            - Drugs with device component
                            - Device with an ancillary medicinal substance
                            Speaker Margareth Jorvid, Methra Uppsala AB

19:05 – 19:35     Combined trials testing medicinal product and IVD/MD together
                                    - Regulatory challenges in conducting combined studies
                                    - EU COMBINE project
                                    - Experience and way forward
                            Speaker Ditte Zerlang Andersen, Danish Medicines Agency Kort paus

19:50 – 20:05     Guidance for the Coordinated Application Process for Combined Studies in Denmark
                                    Speaker Ditte Zerlang Andersen, Danish Medicines Agency

20:05 – 20:35     Regulatory adventures with combination products in the EU
                                    - (Non) integrated; SPP; CDx (Really?)
                                    - Who is the manufacturer
                                    - Strategic Timelines and clinical strategy
                            Speaker Krysten Oates, ProPharma group

20:35 – 20:45     TOPRA news
                                    Speaker Margareth Jorvid, TOPRA volunteer

20:45 - 21:00             Q&A

 

Pricing

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

 

Contact us

Margareth Jorvid at margareth.jorvid@lsmgroup.se, 

Any questions contact: toprainsweden@topra.org 

For any membership queries, please contact membership@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.

 

 

 
When
17/09/2024 18:00 - 21:00
Where
Medicon Village (Room: Sharience), Scheeletorget 1 223 63 Lund LUND SWEDEN
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