Join the Professional Forum – Status and Experiences After the First Year with the Regulation for Clinical Drug Trials

Published 30-11-2022
En kunstnerisk fremstilling af EU-flaget med gule stjerner på en bølgende blå baggrund.

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From January 31, 2023, all clinical drug trials must be submitted via the EU portal CTIS. What does the regulation mean for the application process for clinical trials? And what should an application include? What challenges have been observed in the first year?

These are just some of the questions that arise in connection with the new regulation on clinical drug trials.

On January 31, 2023, the regulation turns 1 year old, and that means all drug trial applications must be submitted via CTIS.

A correct application and organization of a clinical trial are crucial for all parties, and therefore, the Danish Medicines Agency (LMST) and the Danish National Center for Ethics (NCE) invite you to the Professional Forum, where you can get answers to your questions.

The Professional Forum will take place on Wednesday, January 31, 2023, from 15:00 to 17:00 at

Danish Medicines Agency

Axel Heides Gade 1

2300 Copenhagen S

Registration
You register for the Professional Forum by getting a free ticket at billetto.dk

The deadline for registration is Wednesday, January 15, 2023.

There will be physical space for 130-140 participants.

We are exploring the possibility of participating virtually.

If you have questions you want answered, please send them by email to the Danish National Center for Ethics, no later than January 15, 2023.

As far as possible, we will try to answer any questions in connection with the event. Additionally, the Danish Medicines Agency's Q/A will be continuously updated.

The presentation will be held in Danish.

Program for the day:

(the program will be updated with names)

15:00 Welcome by the day's moderator Marianne Pilgaard, Trial Nation
15:15 Status after 1 year's experience - NCE and LMST
15:45 Debate – Our moderator guides a panel of experts in an informative debate
• Case handler from NCE and LMST
• MREC Committee Leader (To be announced)
• GCP Unit Leader (To be announced)
• Applicant (To be announced)
16:30 Questions for the panel (submitted and from the audience)
16.45 Summary of the day
17:00 Goodbye and thank you

Be aware of new requirements for drug trials

For applications for clinical drug trials, we note that the directive will cease on January 30, 2023. All applications must thereafter be applied under the EU regulation for clinical trials with drugs in the common European system (CTIS).

Read more about the EU regulation for clinical trials:

Danish Medicines Agency's website regarding the new regulation for clinical trials..

Clinical Trials with Medicinal Products under the CTR

Contact

LMST: Email to Section for Clinical Trials

NCE: Email to Danish National Center for Ethics