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 focus of 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

Antoinette VAN DIJK
Switzerland
Phone: +41 79 51 17 359
Mobile: +39 335 56083680
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Members

WG Chair: Antoinette van Dijk

WG Members – Vivienne van de Walle (PT&R - The Netherlands), Ornela Cullufe (CVBF - Albania), Claudine Richon (Ennov - France), Şebnem Yaşaroğulları (MENE Research - Turkey), Mahak Aneja (Emovis - Germany), Olga Baula (ULC - Ukraine).

 

FLYER - Clinical Trials Centres WG rev

Chair

Dagmar CHASE
BVMA
Phone: +49 89 92 92 87 0
Fax: +49 89 92 92 87 50
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

The EUCROF Clinical Trials Legislation Working Group (CTL WG) is aimed to represent European CROs when input is sought from stakeholders by legislators (e.g., EMA, EU Commission) or international organisations (e.g., ICH, WHO) in the context of new provisions for clinical trials. It is crucial that CROs provide their perspectives and opinions as more than 60% of clinical trials are handled by CROs. The delegation of sponsor duties and functions to CROs is important to be taken into account when legal regulations and guidance documents are developed. EUCROF does not miss this chance and continuously participates in the consultation rounds offered by legislators and/or international organisations.

The CTL WG is in operation since more than a decade and has given input to numerous documents with latest activities on the “Management of Clinical Trials under COVID-19 Pandemic”.

It is our mission to effectively use the voice we have through the European CRO Federation.

We are looking forward to continue our active involvement in the development of Clinical Trials documents.

 

Members

WG Chair: Dagmar Chase

WG Members – Ulrike Lorch (Richmond Pharmacology - UK), Emma Akuffo (Richmond Pharmacology - UK), Krisztian Bakonyi (OCT-Clinical - Latvia), Carmen Balasa (Optimapharm - Croatia), Mihaela David (PSI CRO - Romania), Tineke de Boer (Pra Health Science - The Netherlands), Natalya Eliseeva (OCT-Clinical - Latvia), Catherine Ferre (PRA Health Sciences - France), Despina Gioka (Next CRO - Greece), Angela Hougardy (proDERM - Germany), Cari Joacobs-Blom (CR2O - The Netherlands), Alexandra Koulouri (Qualitis - Greece), Yuriy Lebed (Pharmaxi - Ukraine), Cristina Manfredi (CVBF - Italy), Phaedra Mavroidi (Qualitis - Greece), Karoly Ringenbach (Optimapharm - Croatia (Germany)).

 

FLYER - Clinical Trial Legislation WG rev

Chair

Michael Shumilin, MD, MBA
Ukrainian Logistic Cluster, Chairman

Kyiv, Ukraine 

ULC - Ukrainian Logistic Cluster (ulc-health.com)

Mobile: +38 050 366 57 00

Phone: +38 044 593 06 01
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Administrative Support

Zaryana Davranova

ULC Poland

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Members

WG Chair: Michael Shumilin

Administrative Support: Zaryana Davranova

WG Members – Emre Akay (Türkiye); Florent Belon (France); Santiago Diaz Prieto (Spain); Iva Hlobilova (Syneos), Martin King (Switzerland); Philippe Lecorre (France); Burak Özcan (Türkiye); Ceren Sağıçımak (Türkiye); Bärbel Wilke (Germany); Yuri Yeretin (Ukraine); Sven Karlsoon (Sweden) - Advisor.

 

Clinical Trials Logistics is a rapidly growing clinical trials industry segment, with a broad variety of new approaches in a very fast-changing environment. New technologies and techniques develop so fast, that industry and communication within industry sometimes simply have to just follow them. The Clinical Trial Logistics Working Group (CTLog WG) is a part of EUCROF, an organisation which aims at facilitating the work of CROs in the EU. Our Working Group focuses on improving processes in Clinical Trial Logistics to be able to provide qualitative and reliable services for leading Clinical Trials in the EU. Any organisation wishing to ease or to better grasp logistics processes or to find reliable providers of logistics services can join the WG on a voluntary basis.

What we do: analyse the processes of Clinical Trial Logistics to identify difficulties in the filing of queries to the EUCROF administration in the Clinical Trial Logistics field, to cope with Regulatory Authorities in the EU; facilitate discussions on importation and exportation guidelines; create innovative approaches in the processes related to Clinical Trial Logistics.

It is expected that the global healthcare contract development and manufacturing market size, where clinical trials logistics covers an important part, will expand massively. That is why Clinical Trial Logistics needs to become reliable, flexible and sophisticated, in order to make Clinical Trials possible for the organisations which lead them.

 

Goals for 2023:

  1. First publication of a Clinical Trial Logistics Glossary
  2. Identify the best way to guide Companies regarding applicable directives for Clinical Trial Logistics.
  3. Prioritise strategic initiatives and present a schedule for guidance development and deliverables for Clinical Trial Logistics

Chair

Christophe GOLENVAUX
BeCRO
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Members

WG Chair – Christophe Golenvaux

 

WG Members – Darina Hrdličková (ACRO-CZ - Czech Republic), Simon Lee (CCRA - UK), Véronique Marty (AFCROs - France), Assia Rosati (EUCROF).

Chair

Jean Paul Deslypere

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Aesculape CRO (Belgium)

 

Members

WG Chair – Jean Paul Deslypere

WG Members – Olivier Simon (VISO CLINICAL srl - Belgium); Arianna Bertolani (CVBF - Italy); Anca Brasoveanu (EastHORN Clinical Services in CEE - Romania); Yves Donazzolo (Eurofins-OPTIMED - France); Amalia Iljasova (OCT Clinical - Latvia); Carla Nascimiento (Leon Research SL - Spain/Portugal/Italy); Peter Smits (CERC - France); Audrius Sveikata (Biomapas - Lithuania); Johan van Daele (BioNotus - Belgium); Ana-Maria Iancu (Arensia - Romania).

Chair

Donato BONIFAZI
Chief Executive Officer - Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF, Italy)

Tel.: +39 080 975 1974
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WG Chair – Donato Bonifazi

Reema Alhwij (CVBF - Italy), Harsha Basudev (Parexel - Italy), Simone Bucerius (FGK Clinical Research - Germany), Ana Dilo Bala (CVBF - Albania), Anamaria Dzoja Horvat (Optimapharm - Croatia), Cristina Florescu Moriad (AVANTYO - Romania), Amalia Iljasova (OCT Clinical - Latvia), Manika Kreka (CVBF – Albania), Ana Maria Moreno Fernandez (Apices Soluciones - Spain), Marieke Meulemans (GCP Central - The Netherlands), Ana Stoiković (Optimapharm D.O.O. - Croatia), Katerina Tsagaraki (Coronis Research - Greece), Goran Vesov (CResT Consulting Ltd - Republic of North Macedonia).

 

ET WG Flyer rev

Chair

Dolores Pérez Méndez

Sermes CRO, Spain

Phone: +34 608 505 507

 Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Members

WG Chair – Dolores Pérez Méndez

WG Members – Stefan Siegmund (Convidia - Germany), Rasid Kamal (PPD - Czech Republic), Lari Forrester (IQVIA - The Netherlands).

 

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)

WG Chair

Şebnem Yaşaroğulları

Vice President Clinical Operations

email: This email address is being protected from spambots. You need JavaScript enabled to view it.

MENE Health Group
Phone. +90(262) 678 88 67 - Fax. +90(262) 751 28 38 - Cell. +90(533) 740 84 63
www.menehealthgroup.com 

Members

WG Chair – Şebnem Yaşaroğulları

WG Members – Antoinette van Dijk (D.O. Research - Switzerland), Karen Gabriels (Archer Research - Belgium), Natalia Gordieyvskaya (ULC - Ukraine), Sofoklis Kyriazakos (Innovation Sprint - Belgium), Antonio Pitarque(Sermes CRO - Spain), Mieke Tempels (Archer Research - Belgium), Rianne Tooten (Acron - The Netherlands), Nazli Aksoy (Mene Research - Turkey).

 

FLYER Medical Devices WG (21 September 2023)

Chair

Fiona Maini 

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(Medidata Solutions - UK)

 

Co-Chair 

Alan Yeomans

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(PCG Solutions AB - Sweden)

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 – Fiona Maini 

WG Co-chair – Alan Yeomans

WG Initiator – Yoani Matsakis

WG Members – Thierry Lepoutre (Lambdaplus – Belgium), Vasiliki Mani (Excelya - Greece), Sofoklis Kyriazakos (Alcoam By Design - France), Yoani Matsakis (TELEMEDICINE TECHNOLOGIES S.A.S. - France), Eva Hanzlova (Scope International - Czech Republic); Taliesin (Tal) Prole (Medidata Solutions UK), Valeria Orlova (Medidata Solutions 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

 

FLYER - New Technology WG rev

Chair

Dr Martine DEHLINGER-KREMER
ICON Plc (Germany)
Phone: +49 1738966437
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Members

WG Chair – Dr Martine Dehlinger-Kremer

WG Members – Alex Cvetkovic Muntañola (Syneos Health – Spain), Sofia Romboli (Excelya -  Greece), Jürgen Schäfer (Conreso GmbH – Germany), Donato Bonifazi (CVBF – Italy), Nira Garty (Perfection-CRO Ltd – Israel), Pavla Nevolova (EastHORN - Czech Republic), Ian Vasicka (Co-Investigator/Advisor - Czech Republic), Nuria Martinez-Alier (IQVIA/Advisor – UK).

 

EUCROF PWG Flyer (16 February 2022)

 

Co-Chair

Jean-Sébastien Gosuin

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Curewiki (Belgium)

 

Co-Chair

Manika Kreka

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CVBF (Albania)

 

Members

Co-Chair: Jean-Sébastien Gosuin, Co-Chair: Manika Kreka, Donato Bonifazi (CVBF - Italy), Irina Petrova (OCT-Clinical - Latvia), Sarka Rozlivkova (PPD - Czech Republic).

 

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 – Jean-Sébastien Gosuin (Belgium), Manika Kreka (Albania), Irina Petrova (Latvia), Sarka Rozlivkova (Czeck Republic), Donato Bonifazi (Italy), Sam Rolfe (UK).

 

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

 

FLYER - Patients Association WG rev

Chair

Marco ANELLI
Senior Medical Advisor
Product Life Group

Corso Italia, 17 - 20122 Milano
Phone: +39 345 3396094
Fax: 

  

Co-Chair

Xavier FOURNIE, M.D.

Scientific Medical Affairs Consulting

Hospital Practitioner*

Mobile: +33 (0)6 08 65 71 12

4 Chemin du Plain Vallon, 69300 CALUIRE ET CUIRE , FRANCE

*HCL- Hôpital Pierre Garraud, SSR/iVie, 136 rue Commandant Charcot, 69005 LYON, FRANCE.

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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 – Marco Anelli

WG Co-chair – Xavier Fournie

WG Members – Nicolas Tsiakkas (Medwork - Greece), Zurab Koberidze (FGK-PV – Germany), Fleming Kjær Jørgensen (Klifo – Denmark), Martijn van de Leur (Biomapas - Lithuania).

 

FLYER - PharmacoVigilance WG rev

 

Chair

Alexandre Malouvier

Senior Director Commercial & Strategic Healthcare & Technology Partnerships

Dir Tel: +33 (0)1 41 34 45 59  

Mobile: + 33 (0)6 14 34 72 31

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Members

WG Chair: Alexandre Malouvier

WG Co-chair: Denis Comet (Axonal - France)

WG Members: Sarah Beeby (consultant - UK), Liliana Cunha (Clinical Trial & Consulting - Portugal), Remi Gauchon (ICTA - France),Sonja Kroep (Pharmerit - The Netherlands), Sofoklis Kyriazakos (Innovation Sprint - Belgium),  Klairi Liakou (Zeincro - Greece), Berk Özdemir (Omega - Turkey), Dana Perotti (Castor - The Netherlands), Nawab Qizilbash (OXON Epidemiology - UK), Giuseppe Recchia (daVinci Digital Therapeutics - Italy), Berber Snoeijer (ClinLine - The Netherlands), Dana Vankova (IQVIA - Czech Republic), Ophélie Wilczynski (Carenity - France).

 

Meetings

Monthly meeting is generally organized through teleconference

 

FLYER - Real World Data and Digital Health WG rev