Observational studies of medicinal products and patient support programmes in the new regulation

CEFI is organising a seminar on observational studies of medicinal products and patient support programmes, which is set to take place on 15 October.

As of 2 January 2021, observational studies of medicinal products for human use (‘OSM’) are to be regulated in Spain by Royal Decree 957/2020, which repeals the previously applicable Order SAS/3470/2009.

With a view to analysing the new regulatory framework and commenting on the interpretative and practical aspects, we will be holding a debate with experts.

We will examine:

The main issues of interest in the new RD on observational studies with medicinal products.

PSPs in the new regulation.

Issues to be taken into account when conducting a new OSM.

The role of the Autonomous Communities and Research Ethics Committees (RECs) in the new regulation. Changes and amendments made to implement the new regulation.

Patients and the new regulation. We will address the new regulation’s reference to patient support programmes and how this should be considered. Such programmes are becoming increasingly common in the face of patient demand for information and services and must be covered by a clear legal framework.

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