Regulatory "CPP-ANSM".
Objectives of the group
- Take stock of the various regulatory advances and their application
- Review the next texts and alert AFCRO members to the main changes.
- Follow the deadlines for submission of studies to CPP and ANSM
- To be a force of proposal to the institutions and regulatory bodies
Operation
The members of the group meet every 4 to 6 weeks, by videoconference.
Members of the group
- Estelle BADEL | MEDPACE
- Maud BEAUCHESNE | IQVIA
- Anne BELEY | PAREXEL
- Sophie BRUSSIEUX | PHARM-OLAM
- Valérie COLLET | BIOFORTIS
- Patricia DEGRI | PRAHS
- Yves DONAZZOLO |EUROFINS OPTIMED
- Ophélie FLAGEUL | SLB Pharma
- Cédric GAUCI | CLINTEC
- Laetitia GIDELLE | PSI
- Alexandra GOBERT | PAREXEL
- Mireille JACQUES | IQVIA (Host)
- Florence LENOIR | PPD
- Magda RACOVITEANU | PSI
- Souad SAHNOUNE | ICON
- Sophie SCHMID | BIOFORTIS
- Coralie VERGARA | BIOFORTIS
- Ophélie WILCZYNSKI | CARENITY
Contact : groupe-reg-cpp@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
Regulatory
CNIL-RGPD
Follow health data protection regulations
Human vigilance
To develop and share good practices for the professional achievement of Clinical Research staff
Decentralised clinical trials
Reflections on the creation of an agile and secure methodology for the development of decentralised clinical trials in France.