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Workshop on new EU regulation re. in vitro diagnostics in September

23-07-2019

Biopeople together with the Danish Medicines Agency invites for a dialogue meeting to debate the new EU regulation on in vitro diagnostics, including companion diagnostics, in clinical trials

The workshop, which takes place on 3 September, is based on the European Commission's recent adoption and publication the new EU regulation (2017/746/EU) regarding in vitro diagnostics (IVD). The new regulation will apply from 2022.

The Clinical Trial Facilitation and Coordination Group (CTFG) and the European Commission (Directorate-General for Health and Food Safety) is collaborating in drafting guidance in this area, supporting the implementation of the new IVD legislation into the setting of Clinical Trials with medicinal products. Among such aspect are questions concerning classification, application procedures and requirements for documentation. The Danish Medicines Agency chairs the CTFG working group, which include both IVD and Clinical Trials experts.

At the meeting the Danish Medicine Agency will present the progress of their work at the CTFG working group, and we encourage participants to debate and provide input to the various aspects.

The input from this workshop will be used in the planning of an EU CTFG IVD workshop in Sweden later in 2019.

The full program of the workshop will be published in August 2019, but we recommend your early expression of interest to participate by signing up at the event site.

Since seats are limited to approx. 30, in order to facilitate meaningful discussions, the organizers will decide on registrations in excess.

Please note, this is a national dialogue meeting and we encourage people outside Denmark to sign up for the workshop in Sweden.

More information at: https://laegemiddelstyrelsen.dk/en/devices/legislation-and-guidance/new-regulations/

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