Speaker Profile
Fabio D’atri

Fabio D’atri PhD

Biochemistry and Molecular Genetics, Immunology and Microbiology
Brussels, Brussels, Belgium

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Mr. Fabio D’Atri, Deputy Head of Unit in Directorate General Health and Food Safety, gave an overview of the main provisions of new regulation on clinical trials. In particular, he explained that in the protocol, a description of the group/subgroups participating in the trial has to be given together with a justification for the gender and age allocation of subjects.Furthermore, if a specific gender or age group is excluded from thetrial, the reasons have to be given. He also explained that the assessors of a clinical trial application will have to have a specific expertise if the trial is designed for a specific population group, such as the new provisions to facilitate the conduct of clinical trials and to collect data in pregnant and breastfeeding women.

Finally, he presented the main features of the future EU portal and EU database under preparation by the European Medicines Agency, which will greatly increase the transparency and information concerning clinical trials in Europe.
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