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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 (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

     

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