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.
Antoinette VAN DIJK
Switzerland
Phone: +41 79 51 17 359
Mobile: +39 335 56083680
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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).
Dagmar CHASE
BVMA
Phone: +49 89 92 92 87 0
Fax: +49 89 92 92 87 50
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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.
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)).
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
Oksana Nedostup
ULC
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WG Chair: Michael Shumilin
Administrative Support: Oksana Nedostup
WG Members – Emre Akay (Türkiye); Florent Belon (France); Santiago Diaz Prieto (Spain); 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:
Christophe GOLENVAUX
BeCRO
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
WG Chair – Christophe Golenvaux
WG Members – Darina Hrdličková (ACRO-CZ - Czech Republic), Simon Lee (CCRA - UK), Véronique Marty (AFCROs - France), Assia Rosati (EUCROF).
Jean Paul Deslypere
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Aesculape CRO (Belgium)
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).
Donato BONIFAZI
Chief Executive Officer - Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF, Italy)
Tel.: +39 080 975 1974
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
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).
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.
WG Chair – Dolores Pérez Méndez
WG Members – Stefan Siegmund (Convidia - Germany), Rasid Kamal (PPD - Czech Republic), Lari Forrester (IQVIA - The Netherlands).
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.
Meeting by teleconference (Monthly/ every two months)
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).
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.
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.
Dr Martine DEHLINGER-KREMER
ICON Plc (Germany)
Phone: +49 1738966437
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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)
Jean-Sébastien Gosuin
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Curewiki (Belgium)
Manika Kreka
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CVBF (Albania)
Co-Chair: Jean-Sébastien Gosuin, Co-Chair: Manika Kreka, Donato Bonifazi (CVBF - Italy), Irina Petrova (OCT-Clinical - Latvia), Sarka Rozlivkova (PPD - Czech Republic).
Fostering actual & confident collaboration with patients in clinical research.
WG Members – Jean-Sébastien Gosuin (Belgium), Manika Kreka (Albania), Irina Petrova (Latvia), Sarka Rozlivkova (Czeck Republic), Donato Bonifazi (Italy), Sam Rolfe (UK).
Webinar meetings on a monthly base.
Face-to-face meetings.
Marco ANELLI
Senior Medical Advisor
Product Life Group
Corso Italia, 17 - 20122 Milano
Phone: +39 345 3396094
Fax:
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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Position EUCROF PV WG as important conduit and as a reference for stakeholders in the EU pharmacovigilance fora
Main objectives:
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).
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
email: This email address is being protected from spambots. You need JavaScript enabled to view it.
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).
Monthly meeting is generally organized through teleconference
Šárka Blažková
Manager Clinical Operations II
M: +420 728 216 207
email: This email address is being protected from spambots. You need JavaScript enabled to view it.
The Task Force is there to to face the increasingly challenging situation regarding the job market for clinical research.
Sarka BLAZKOVA – Chairperson
Alexandre Malouvier
Anne Himmel
Benedikt Van Nieuwenhove
Katharina Knebel
Mirjam Huigen
Sue Fitzpatrick
Meetings
Usually, the Task Force meets on a call every month.
Join us!
If you are interested in becoming a member of this important Task Force, please contact:
EUCROF Secretariat
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The Task Force has identified some potential solutions. The Task Force would welcome your involvement in taking the initiative further. Your experience and point of view can change the world of clinical trials.