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Presentation Our objectives Our Team

Our Team

The Board

Elem AYNE

PRESIDENT

president@team-prrc.eu

Anne JURY

VICE-PRESIDENT

inform@team-prrc.eu

Bassil AKRA

VICE-PRESIDENT

inform@team-prrc.eu

  • PRRC for an Authorised Representative company and Manufacturers
  • Regulatory Affairs Consultant at  ACR Medical
  • Auditor
  • > 8 years experience in Industry
  • Regulatory affairs consultant
  • Over 25 years experience in the medical and diagnostic healthcare techhnology industries
  • Former lead auditor at BSI and TÜV SÜD
  • Supporting Medical Device and In-Vitro Diagnostic Industry to get safe, qualitative and well-performing products on the market
  • Former vice-president at     TÜV SÜD Product Service GmbH

Kawtar IDIHYA

TREASURER

treasurer@team-prrc.eu

Jean-Louis DIVOUX

SECRETARY

secretary@team-prrc.eu

Ronald BOUMANS

MEMBER OF THE BOARD

inform@team-prrc.eu

  • Biomedical Engineer
  • Regulatory Affairs/Quality Assurance (RA/QA) Engineer for medical devices
  • 2 years experience in Medical Devices
  • Over 30 years experience in Active Implantable Medical Devices (Class III AIMDs)
  • Standardisation commitees member
  • AIMD Expert and Adviser
  • Over 30 years of experience in Medical Devices
  • PRRC and Program Manager EMERGO by UL
  • 11 years as inspector - The Netherlands Competent Authority

The Advisory Board

Denys DURAND-VIEL

Corinne DELORME

David R RUTLEDGE

  • Entire career in medical devices
  • Auditor for german notified bodies
  • President of DM Experts
  • Involved in the implementation of EU and other countries regulations
  • Head of GMED notified body for >15 years
  • Regulatory Intelligence Director of NEXIALIST
  • More than 25 years experience
  • Leading international regulatory submission
  • President at Global Strategic Solution LLC in USA

Daniel PETIT

Founder member

  • Sales training manager for pharmaceutical manufacturer
  • Regional Manager for different MD manufacturers in France (class IIa and IIb)
  • Founder and President of a Manager's MD association

The Representative PRRC

René DROST

for The Netherlands

Anna AMICH

for Spain

Piero COSTA

for Italy

  • 15 years of experience in Medical Devices, at Hospital level as well as Industry
  • Director of NAMCO and FSCA.com
  • Secretary of the NL MDR/IVDR Implementation group
  • Tutor for Biomedical Engineers and Clinical Perfusionists
  • 20 years of experience in Pharmacovigilance and Medical Device Post-Market Surveillance and Vigilance
  • Deputy QPPV and PRRC officer at Novartis
  • BSc in Pharmacy and Biochemistry, MS in Clinical trials Monitoring, PG Certificate in Epidemiology.
  • + 16 years of experience in Medical Devices
  • PRRC and Technical Director
  • Vice-President of the BioPmed Cluster
  • B.S.I External Tutor for Medical Devices

José MALTA

for Portugal

Carole ROBIN

for France

Raje MARIKKANNU

for Sweden

  • PharmD | + 15 years of experience in Medical Devices
  • PRRC for Manufacturers
  • ISO and GxP Auditor
  • Associate member of OF - Portuguese Order of Pharmacists and APREFAR – Portuguese Regulatory Affairs Professional Association
  • Invited expert designated by APORMED – Portuguese Association of Medical Devices Companies
  • Over 30 years of experience in Medical Devices (Regulatory, Quality), and 20 years in Clinical Research (international clinical investigations - Competent authority inspection (ANSM) and Clinical Investigations Auditor (MDR and ISO 14155))
  • PRRC for Manufacturers
  • PharmD, MS in Quality
  • +12 years experience in the MD/IVD industry
  • Founder & Consultant - Trinetra Solutions AB
  • PRRC for Manufacturers & EAR
  • SaMD Expert & Auditor
  • RAC Certified from the RAPS, USA

Sandra FERRETTI

for Belgium

Christopher KIPP

for Germany

Eric KLASEN

for Switzerland

  • +25 years experience in EU Medical Devices regulatory affairs and Cosmetics regulations
  • Chief Compliance Officer and Public Affairs Director at Obelis
  • Accredited expert in the European Union Medical Device Coordination Group (MDCG)
  • Involved in various European Commission working groups
  • Recognized international speaker/moderator at seminars and conventions
  • Manager Regulatory Affairs at BVMed (Germany medtech association)
  • Responsible for working groups PRRC, Labelling, Standards, NB, Supplier and more. Both in the german WG’s and MTE WG’s
  • Consultant in Life Sciences and expert in Regulatory Affairs, QA, and Quality Management Systems
  • Board of Directors member of EFGCP, Belgium
  • Board of Directors member of SimpliNext, Switzerland
  • Advisory Board member of REA Diagnostics, Switzerland
  • Supervisory Board member of Diabeter, a group of Diabetes Clinics, the Netherlands
  • Chair of the Supervisory Board of NOK, a group of Obesity Clinics, the Netherlands  

The Contributors for Position Papers

Emile UNK

Nadine ADIA

 

  • MSc in Criminal Justice & Public Security
  • Experience & knowledge of Regulatory affairs in various fields
  • PRRC for an EAR company

 

 

  • PharmD /+ 10 years of experience in Pharmaceutical and medical device
  • Regulatory affairs Director and PRRC for manufacturer
  • Certified ISO 13485:2016 Internal Auditor (TPECS)

 

TEAM-PRRC
38 rue des Mathurins
75008 PARIS
FRANCE
contact : inform@team-prrc.eu
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