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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

  1. Introduction to RBM
  2. Sharing of experience on RBM technique and its application
  3. 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

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