Regulatory Single Convention
Objectives of the group
- Exchange of experience on the use of the Single Convention
- Establishment of practical recommendations
- Relations with LEEM, CNCR, DGOS in particular concerning recommendations on specific parts of imaging, biology, pharmacy, etc.
Operation
Meeting every 2 months
Actions
- Participation in the National Day of Clinical Research
- Organization of breakfasts
Group Members
- Chaynez Amiar | PRA
- Jean-Etienne Audoli | Synteract
- Laïla Benouda | PRA
- Laura Bonnefond | RCTs
- Valérie El Fouikar | IQVIA – co-host
- Marion Hébert | PRA
- Aurelie Marot | PSI – co-host
- Katia Muckensturm | Pharm-Olam
- Patricia Priou | Parexel
- Aude Renault | ICON
- Ghita Taghi | PSI
- Charlène Villelonge | Medpace
- Laure Akpolou | Medpace
Contact : groupe-reg-cu@afcros.com
With all the new regulations to be published in 2016 and those to come in 2017, it seemed important to share experiences and expertise, and also to pool efforts to make the voice of CROs heard by institutions and regulatory bodies.
A « Regulatory » working group was therefore created with 3 sub-groups on the following topics:
- CPP and ANSM submissions
- The V2 Single Convention
- Reference methodologies and the CNIL
The different sub-groups meet every 4 to 6 weeks, alternating between Face2Face and telephone meetings.
The objectives of the sub-groups are :
- To take stock of the different regulatory advances and their application
- Review the next texts and alert AFCRO members to the main changes.
- To be a force of proposal to the institutions and regulatory bodies
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
- DUBOIS Delphine – KEYRUS LIFE SCIENCE
- BOUDAUD Stéphane – ICON
- HUVET Celine – PPD
- FAYOL PAGET Christine – ICON
- VERGARA Coralie – BIOFORTIS MERIEUX NUTRISCIENCES
- JULIEN Emilie – AXONAL
- VELASQUEZ-GIRON Hélène – RCTS
- ABOUSAHL Isabelle – ALCOAM
- DUBOURG Nicolas – TELEMEDECINE
- FLAGEUL Ophelie – SLB HARMA
- D’HONDT Olivier – SOLADIS
- BRUSSIEUX Sophie – PHARM-OLAM
- VILLELONGE Charlène – MEDPACE
- JEANBAT Viviane – CEMKA EVAL
- GOBERT Xavier – MyDATA-TRUST
- MATSAKIS Yoani – TELEMEDICINE
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.