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.

 

Members

WG Chair: Dagmar Chase

WG Members – Ulrike Lorch (Richmond Pharmacology - UK), Simon Lee (Quotient - UK), Ana Zamora (PPD - Spain), Michèle Garot (Clincellence - Belgium), Eirini Tsante (Next CRO - Greece), Maria Isychou (Zeincro - Greece), Carmen Masanneck (Easthorn).

Chair

Christophe GOLENVAUX
BeCRO
E-mail: 

 

Members

WG Chair – Christophe Golenvaux

WG Members – Darina Hrdličková (ACRO-CZ - Czech Republic), Simon Lee (CCRA - UK), Véronique Marty (AFCROs - France) Juraj Gaplovsky (SACROP - Slovenia), Mariangela Lupo (CVBF - Italy), Ignacio Jimenez (Sermes - Spain), Assia Rosati (EUCROF).

Chair

To be defined.

 

Members

WG Chair – Simon Hutchings

WG Members – Harry Therianos (CORONIS Research – Greece), Phil Evans (Quotient Sciences – UK), Yves Donazzolo (Euorfins-OPTIMED – France).

Chair

Donato BONIFAZI
Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)
E-mail: 

WG Chair – Donato Bonifazi

WG Members – Elena Ottavianelli (FullCRO – Italy), Manika Kreka (CVBF – Albania).

Chair

Dolores PÉREZ MÉNDEZ

Sermes CRO, Spain

Phone: +34 608 505 507

 Mail:

 

Members

WG Chair – Dolores Pérez Méndez

WG Members – Christina-Errika Kostopoulou (NextCRO – Greece), Stefan Siegmund (Convidia - Germany).

 

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

To be defined

 

Members

WG Chair: 

WG Co-chair: Denis Comet

WG Members: Michela Masoero (Medineos – Italy), Georgie Nock (pH Associates – UK), Liliana Cunha (Clinical Trial & Consulting – Portugal), Julie De Wever (Keyrus – Belgium), Hubert Mechin (Helsia – France), Aize Smink (Julius Clinical - The Netherlands), Dana Vankova (IQVIA - Czech Republic).

 

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

 

Members

WG Chair – Ayse Burcu Cehreli

WG Members – Antoinette van Dijk (AICRO – Italy), Sule Mene (Mene Health Group – Turkey), Nancy Cottigny (Adhoc Clinical – Belgium), Franz Josef Binmoeller (SyneosHealth – Germany).

 

pdfEUCROF Medical Device WG Brochure

Chair

Alan Yeomans

Quality Manager 

PCG Solutions AB 

Mobile : +46 70 540 0299 

 

Co-Chair 

Yoani Matsakis 

President 

TELEMEDICINE TECHNOLOGIES S.A.S. 

Mobile: +33 6 85 04 57 21

 

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 – Thierry Lepoutre (Lambdaplus – Belgium), Michèle Garot (ClinCellence -Belgium), Isabelle Abousahl (Alcoam By Design – France), Sarah Dubray (ICON - France), Vassiliki Mani (Zeincro Hellas – Greece), Ignacio Jimenz (Sermes – Spain), Keith Berelowitz (Richmond Pharmacology – UK).

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

Nadia CHEAIB

ClinServ 

E-mail: 

Members

WG Chair – Nadia Cheaib

WG Members – Giulia Chiaruttini (Pharm – Italy), Aleksandra Klimaszewski (UL International GmbH - Germany).

Chair

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

 

Members

WG Chair – Martine Dehlinger-Kremer

WG Members – Alex Cvetkovic Muntañola (Syneos – Spain), Sofia Romboli (Zeincro Hellas -  Greece), Jürgen Schäfer (Conreso GmbH – Germany), Donato Bonifazi (CVBF – Italy), Nira Garty (Perfection-CRO Ltd – Israel), Erik Hamminga (Chiltern - The Netherlands), Valentyna Telnova (freelancer, consultant – Ukraine), Ian Vasicka (GynCentrum Praha - Czech Republic), Nuria Martinez-Alier (IQVIA – UK), Dawn Gbekor (PPD – UK).

 

pptEUCROF Paediatric WG Brochure

 

Chair

Hervé SERVY

hservy@sanoia.com"

Sanoïa Digital CRO

(www.sanoia-digital-cro.com)

 

Co-chair

Alain Baleydier

RCTS

(www.rcts.fr)

 

Goals

Fostering actual & confident collaboration with patients in clinical research.

 

  1. Contribute to promote and disseminate best practices of collaboration with patients’ associations involved in study design, run and patient retention in clinical studies.
  2. Ease the effort of CROs having need to involve patients in national and/or international projects.
  3. Ensure involvement of EUCROF as a stakeholder providing consolidated CRO perspectives about the operational collaboration with patients in clinical research. 
  4. Contribute to the recognition by authorities, industry and patients’ advocacy groups of best practices of collaboration with patients in clinical studies and access to innovation.
  5. Create and maintain an annual observatory of patient-centricity experiences and patients associations’ expectations about clinical studies across European countries.

 

Members

WG Members – Hervé Servy (FR), Alain Baleydier (FR), Xavier Fournie (FR), Michel Lévy (FR), Marta Manso (ES), Joyce Moore (UK), Lamine Mahi (FR), Manika Face Kreka (ALB), Ornela Cullufe (ALB)

 

Meetings

Webinar meetings on a monthly base.

Face-to-face meetings.

 

Distribution of Information

  • EUCROF conferences
  • Social media
  • White papers
  • Position papers
  • Publications in journals
  • Scientific conferences
  • Cross communication with patients’ advocacy groups
  • EUCROF website

 

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

 

Goals

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

 

Members

WG Chair – Nicolas Tsiakkas

WG Co-chair – Xavier Fournie

WG Members – Marco Anelli (Productlife-group – Italy), Zurab Koberidze (FGK-PV – Germany), Miranda Dollen (ICON – UK), Essam Ghanem (Vigi-Care – Belgium), Fleming Kjær Jørgensen (Klifo – Denmark).