TOPRA in Sweden: New Regulation CTR/CTIS

TOPRA in Sweden: New Regulation CTR/CTIS
TOPRA in Sweden welcomes you to a presentation on regulatory support to Start-ups / Academia and Clinical trials and the new regulation CTR/CTIS.






Date:  Wednesday 23 November 2022
Time: 17:30-20:00 GMT / 18:30 – 21:00 CET

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

Address: GoCo Health Innovation City, Kärragatan 5, 432 53 Mölndal   

As of January 31, 2022, an EU common Regulation 536/2014 (also called Clinical Trials Regulation, CTR) applies to clinical trials of medicines for humans, regardless of whether the trials are commercial or not and thus also includes academic research. A single application is sent to an EU-common web portal and database (CTIS) and results, after an EU-common investigation process, in a national decision. After 31 January 2023, all new applications for clinical drug trials must be submitted and carried out according to the EU Regulation.

This evening is an excellent opportunity to hear experiences of clinical trials under CTR and via CTIS. We will also hear what support the Swedish Medicines Agency can give to academia and start-up companies via the Innovation Office and scientific advice, as well as 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.

Agenda

18:00 – 18:30 Light refreshments (sandwiches and drinks)

18:30 – 18:35 Introduction 
                                Helena Ardebrant - TOPRA volunteer

18:35 – 18:50 Welcome to GoCo 
                                Maria Uddenmyr - GoCo Health Innovation City
                                Linnea Fogelmark - Health Works

18:50 – 19:15 The Medical Products Agency 
                                • MPA support to academia and small start-ups
                                • Innovation office
                                • Scientific Advice
                       Anna Mäkinen Salmi - Medical Products Agency, Uppsala

19:15 – 19:40 Experience of clinical trials according to new CTR
                               • The New Regulation
                               • Application via CTIS
                               • Experiences
                                Marianne Andersson - AstraZeneca

Short break

19:50 – 20:25 CTR and the Medical Products Agency
                               • EU-common review process
                               • Transition rules
                               • Experiences 
                       Gunilla Andrew-Nielsen - Medical Products Agency

20:25 – 20:45 Transparency and new CTR
                               • Which document become public (IB, protocol etc) 
                               • Sponsor thoughts
                       Marianne Andersson - AstraZeneca

20:45 – 20:50 TOPRA news
                        Margareth Jorvid - TOPRA volunteer

20:50 - 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

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Any questions, contact: toprainsweden@topra.org.
When
23/11/2022 17:30 - 20:00
Where
GOTHENBURG SWEDEN
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