Working Groups

EUCROF encourages the initiatives of its Members to form Working Groups (WGs), which represent an open area of discussion on specific areas of interest for Members. Any (Associate) Member can contribute to the WGs by nominating a representative. The WGs meet regularly through TCs and/or face to face meetings. In accordance to the focusof each WG, they are intended to become counterpart/stakeholders for Regulatory Authorities, Industry, Academia and Patients Associations, write papers in Scientific Journals, actively participate to Congresses/Conferences, thus representing the position and the interests of EUCROF. 

Chair

Dagmar CHASE
BVMA
Phone: +49 89 92 92 87 0
Fax: +49 89 92 92 87 50
E-mail: 

The Working Group "Clinical Trials Legislation" (WG CTL) is proud to report on the following achievement:

When issuing comments regarding the EMA Reflection Paper on Risk-based Quality Management, the WG proposed a flow chart improving the chart given in the draft version of the Reflection Paper. EUCROF was asked for permission for the Inspectors Working Group (owner of the
Reflection Paper) to use the  EUCROF chart in the final version (with slight text edits). We are happy to have made a valuable contribution to such an important document which is on the front line of discussions on Quality by Design, Risk-based Quality Management in general, and Risk-based Monitoring in particular.

We are looking forward to continue our active involvement in EU Clinical Trials documents.

Chair

Christophe GOLENVAUX
BeCRO
E-mail: 

Chair

Antoinette van DIJK
E-mail: 

Chair:

Dolores Pérez (Sermes CRO, Spain)

Phone:  +34 608 505 507

Mail:

Members:

Christina Kostopoulou 

Stefan Siegmund

Mission of WG:

The goal of this WG is to identify, examine and provide solutions to the principal issues identified in Advanced Therapy Medical Products development and regulation, in constant dialogue and collaboration with the Industry and European Authorities.

Main objectives:

  • Profiling of EUCROF towards the ATMPs Authorities in EU.
  • Profiling of EUCROF towards the Advanced Therapies industry.
  • Propose solutions to improve the application and assessment process related to ATMPs.

Meetings:

Meeting by teleconference (Monthly/ every two months)

Chair

Giovanni FIORI
MediNeos S.U.R.L
Phone: +39 059 8860134
Fax: +39 059 848305
E-mail: 

Members

WG Chair:           Giovanni Fiori 

WG Co-chair:     Denis Comet 

WG Members:   Liliana Cunha; Julie De Wever;  Remi Gauchoux; Hubert Mechin;  Aize Smink; Dana Vankova

Meetings

Monthly meeting is generally organized through teleconference

Chair

Burcu CEHRELI

Head of Clinical Operations ∙ MENE Research

email:   
Direct: +90(262) 678 8867 ext:102 
Mobile: +90(507) 812 90 40 
Fax: +90(262) 751 28 38

www.meneresearch.com

 

pdfEUCROF Medical Device WG Brochure

Chair

Yoani Matsakis 

President 

TELEMEDICINE TECHNOLOGIES S.A.S. 

Mobile : +33 6 85 04 57 21 

Co-chair: Alan Yeomans 

Quality Manager 

PCG Solutions AB 

Mobile: +46 70 540 0299

The group evaluates new technologies that impact the clinical trial environment and evaluates how these can benefit clinical research.

 

Goals

  • Keep EUCROF Members informed on directions in New Technology
  • Technology survey: how much technology can improve clinical trials
  • Position EUCROF as an expert / key stakeholder for the EU regulatory bodies

Members

WG Chair – Alan Yeomans

WG Co-chair – Yoani Matsakis

WG Initiator – Yoani Matsakis

WG Members – Paulin Charliquart, Sarah Dubray, Thierry Lepoutre, Julien Marcot, Michèle Garot, Marion Caperaa

External Subject Matter Expert – Isabelle Abousahl


Meetings

Webinar meetings are approximately once a month (about 10 times a year).

Face-to-face meetings can be held in conjunction with EUCROF conferences if there is a need.

Distribution of Information

  • EUCROF conferences
  • White papers distributed through the EUCROF website
  • Looking into the use of webinars
    • Can be open to members or non-members
    • Can be paying or non-paying webinars
  • Looking into the use of social media
    • EUCROF have an active LinkedIn group which can be used for appropriate information

Chair

Martine DEHLINGER-KREMER
BVMA
Phone: +49 911946469 0
Fax: +49 91194646999
E-mail: 

pptEUCROF Paediatric WG Brochure

Chair:

Hervé SERVY
gsm  : +33 6 71 31 99 17
Skype: hservy
fax  : +33 4 84 25 21 38
SANOIA.com

Chair

Nicolas TSIAKKAS
Scientific Director
Medwork Pharma Research & Consulting
5, Chiou st., 164 52 Argyroupoli, Athens, Greece
Phone: +30 210 9960971
Fax: +30 210 9969578

Co-Chair

Xavier FOURNIE

Corporate Medical Director

Executive Vice-President, Global Medical Affairs – Real World Evidence, Mapi Group

Phone: +33 (0)4 72 13 66 85

Mobile: +33 (0)6 88 20 00 61

27 rue de la Villette | 69003 LYON | FRANCE

www.mapigroup.com


E-mail: 

 

Goal

Position EUCROF PV WG as important conduit and as a reference for stakeholders in the EU pharmacovigilance fora

Main objectives:

  • Cooperation with other EUCROF Working Groups
  • Pro-active Interaction with the Agency
  • Affiliation with relevant stakeholder groups
  • Sharing PV expertise within the EUCROF
  • PV Knowledgebase Build-up and Dissemination