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

Expertise française sur l'évaluation clinique des 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