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Regulatory Single Convention

Objectives of the group

  • Exchange of experience on the use of the Single Convention
  • Establishment of practical recommendations
  • Relations with LEEM, CNCR, DGOS in particular concerning recommendations on specific parts of imaging, biology, pharmacy, etc.

Operation

Meeting every 2 months

Actions

  • Participation in the National Day of Clinical Research
  • Organization of breakfasts

Group Members

  • Chaynez Amiar | PRA
  • Jean-Etienne Audoli | Synteract
  • Laïla Benouda | PRA
  • Laura Bonnefond | RCTs
  • Valérie El Fouikar | IQVIA – Host
  • Marion Hébert | PRA
  • Aurelie Marot | PSI – Host
  • Katia Muckensturm | Pharm-Olam
  • Patricia Priou | Parexel
  • Aude Renault | ICON
  • Ghita Taghi | PSI
  • Charlène Villelonge | Medpace

With all the new regulations to be published in 2016 and those to come in 2017, it seemed important to share experiences and expertise, and also to pool efforts to make the voice of CROs heard by institutions and regulatory bodies.

A « Regulatory » working group was therefore created with 3 sub-groups on the following topics:

  • CPP and ANSM submissions
  • The V2 Single Convention
  • Reference methodologies and the CNIL

The different sub-groups meet every 4 to 6 weeks, alternating between Face2Face and telephone meetings.

The objectives of the sub-groups are :

  • To take stock of the different regulatory advances and their application
  • Review the next texts and alert AFCRO members to the main changes.
  • To be a force of proposal to the institutions and regulatory bodies

Objectives of the group

  • Review the new texts of the CNIL and alert AFCROs members to the main changes.
  • To be a driving force in making proposals to the CNIL on the revision or development of reference methodologies or, more generally, on the implementation of the RGPD.
  • Develop guides/helpers for AFCRO members
  • Participate in the drafting of the EUCROF Code of Conduct RGPD

Operation

The group meets monthly by phone and quarterly in Face2Face meetings.

Actions

  • Organization of several « breakfasts » (PIA, Violations of the GDMP)
  • Facilitation of an RGPD/Code of conduct workshop at the JRC day
  • Participate in RGPD Code of Conduct meetings with various associations involved in clinical research.

Group Members

  • DUBOIS Delphine – KEYRUS LIFE SCIENCE
  • BOUDAUD Stéphane – ICON
  • HUVET Celine – PPD
  • FAYOL PAGET Christine – ICON
  • VERGARA Coralie – BIOFORTIS MERIEUX NUTRISCIENCES
  • JULIEN Emilie – AXONAL
  • VELASQUEZ-GIRON Hélène – RCTS
  • ABOUSAHL Isabelle – ALCOAM
  • DUBOURG Nicolas – TELEMEDECINE
  • FLAGEUL Ophelie – SLB HARMA
  • D’HONDT Olivier – SOLADIS
  • BRUSSIEUX Sophie – PHARM-OLAM
  • VILLELONGE Charlène – MEDPACE
  • JEANBAT Viviane – CEMKA EVAL
  • GOBERT Xavier – MyDATA-TRUST
  • MATSAKIS Yoani – TELEMEDICINE

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