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 – 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
- Noura Khatra – Medpace
- 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
Attractivité
Agir avec et auprès de tous les acteurs pour que la France soit un pays attractif pour la Recherche Clinique
Dispositifs médicaux
Métiers de la recherche clinique
Promouvoir les métiers de la recherche clinique auprès des étudiants et des professionnels
Real world data
Expertise Française sur les données primaires et secondaires en vie réelle
Risk based monitoring
Patients & recherche clinique
Les patients au cœur de la recherche clinique