Regulatory Affairs

Chairs: Maria Angeles Alonso (ESC) and Susan Longman (Novartis)

Stethoscope

Objective:

To continue the scientific dialogue established between the ESC and the European Medicines Agency on the requirements for registration in specific therapeutic areas.
The EMA welcomes the concept of these regulatory workshops, jointly organised by the ESC and the Industry, under the CRT umbrella, on topics of common interest for the 3 actors.

Format:

Organisation of regular workshops, with participation from academic, industry and regulatory experts, which provide industry and ESC with an opportunity to submit input to regulators.
One of the expected outcomes of these workshops is the production of a written document, summarizing the issues addressed and the recommendations of the group, for publication in the EHJ.

Time frame:

Long-standing.

Topics:

Topics are selected in collaboration with EMA and validated during the CRT plenary meetings.

14 & 15 June 2012 - "The Large Simple Study" - London

> see attached agenda.

10 February 2012 - "Ethnicity and CVD - consequences for generalizing study results" - Amsterdam

> see attached agenda.

Previous workshops:

15 & 16 September 2009 - "Atrial Fibrillation" - London

> see attached agenda.

This meeting offered participants the opportunity to debate and provide comments on the new EMA document "Addendum on atrial fibrillation to Anti-arrhythmics guideline" before its submission to EMA CHMP.