Regulatory « CNIL-RGPD »

Objectives of the group

Review the new texts of the CNIL and alert AFCROs members to the main changes.
To be a driving force in making proposals to the CNIL on the revision or development of reference methodologies or, more generally, on the implementation of the RGPD.
Develop guides/helpers for AFCRO members
Participate in the drafting of the EUCROF Code of Conduct RGPD

Operation

The group meets monthly by phone and quarterly in Face2Face meetings.

Actions

Organization of several « breakfasts » (PIA, Violations of the GDMP)
Facilitation of an RGPD/Code of conduct workshop at the JRC day
Participate in RGPD Code of Conduct meetings with various associations involved in clinical research.

Group Members

Isabelle ABOUSAHL – ALCOAM
Cécile ALLAIN – ICON
Romain BOIDIN – CLINITYX
Claudine BLOTTIERE – ICON
Christophe CAMUS – BIOFORTIS MERIEUX NUTRISCIENCES
Olivier D’HONDT – SOLADIS – Host
Alicia DUTRANNOIT – PSI CRO
Christine FAYOL PAGET – ICON
Ophélie FLAGEUL – SLB PHARMA
Nathalie GIRAUD – PPD
Morgane HUGUET – My DATA-TRUST
Viviane JEANBAT- CEMKA EVAL – Host
Yoani MATSAKIS – TELEMEDICINE
Philippe MOREAU – PPD
Emilie PAIN – CARENITY
Manuella PEREIRA – MEDPACE
Didier NOT – RCTS
Coralie VERGARA – BIOFORTIS MERIEUX NUTRISCIENCES

Contact : groupe-reg-cnil@afcros.com

Attractiveness

Acting with and with all stakeholders to make France an attractive country for Clinical Research

Medical devices

French expertise on the clinical evaluation of medical devices

Clinical Research Professions

Promote clinical research careers among students and professionals

Real world data

French expertise on real life primary and secondary data

AI & Clinical Research

Use of Artificial Intelligence to serve our CRO professions

Patients and Clinical Research

Patients at the heart of clinical research

Regulatory
single convention

Monitor the use of the single convention

Regulatory
CPP-ANSM

Follow the regulations relating to study authorization requests