Risk based monitoring

Objectives of the group

Following the 8th Clinical Research Day (2019) and the Risk-Based Monitoring Workshop, a real need was identified on the implementation of RBM studies and practices used.

A dedicated working group has been created with the following objectives:

inform and communicate about RBM, its regulatory context and its implementation;
exchange on practice with all stakeholders.

Operation

Introduction to RBM
Sharing of experience on RBM technique and its application
RBM in Investigative Centres

Actions

development of communication tools: practical information sheets (reminder of FDA, EMA, Transcelerate regulations and recommendations; definitions and terminology, etc.)
learning from each other
organization and participation in dedicated events

Group Members

- Nathalie Amar – Kelly OCG ( host)
- Stéphane Hoppe – PRA Health Sciences (co-host)
- Fatima El Ghaib – KellyOCG
- Zakaria Maarouf – Kelly OCG
- Frederique Fauduet – Pharm Olam
- Alexandra Fursy- Axonal Biosatem
- Nathalie Giraud – PPD
- Benoit Gonzales – Medi-Link
- Margaux Gouysse – Clinigrid
- Yasmine Domingo –
- Josiane Ngomlonb- 4 Clinics
- Claire Lemaitre – Soladis
- Elodie Jadot – Soladis
- Isabelle Martin – RCTs
- Camille Motbal – Biofortis
- Yassine Omri – Keyrus Biopharma
- Anne-Claire Thieullin – Evamed
- Aurélie Vidal-Gonthier – Medpace
- Elsa Llobet-Merkling – Euraxi Pharma
Contact : groupe-rbm@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