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
Nicolas THEVENET
France
E-mail: n.thevenet@euraxipharma.fr
Members
WG Chair: Nicolas Thevenet
WG Members:
- María Díez Llamazares (Leon Research – Spain)
- Hedda Magnusson (Link Medical – Sweden)
- Denis Comet (Blue Cared – France)
- Nancy Cottigny (AdHoc Clinical – Belgium)
- Ine Vercammen (Meclinas – Belgium)
- Grit Andersen (Profil – Germany)
- Stefania Suarez Gonzalez (Namsa – Spain)
- San Isidro (Iberania – Spain)
- Lucia Garcia (Namsa – Spain)
- Raquel Sofia Cordiero (Namsa – Spain)
Chair
Antoinette VAN DIJK
Switzerland
Phone: +41 79 51 17 359
Mobile: +39 335 56083680
E-mail: antoinette.vandijk@doresearch.ch
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).
Chair
Dagmar CHASE
BVMA
Phone: +49 89 92 92 87 0
Fax: +49 89 92 92 87 50
E-mail: dagmar.chase@clinrex.com
Members
WG Chair: Dagmar Chase
WG Members:
- David Ruwe (SGS proDERM – Germany)
- Ulrike Lorch (Richmond Pharmacology – UK)
- Alexandra Koulouri (Qualitis – Greece)
- Catherine Ferre (ICON – France)
- Mihaela David (PSI CRO – Romania)
- Tineke de Boer (ICON – The Netherlands)
- Cari Joacobs-Blom (CR2O – The Netherlands)
- Yuriy Lebed (Pharmaxi – Ukraine)
- Cristina Manfredi (CVBF – Italy)
- Phaedra Mavroidi (Qualitis – Greece)
- [GUEST MEMBERS: Giorgio Reggiadro (CVBF – Italy), Dilshat Djumanov (Richmond Pharmacology – UK)]
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 CROs are involved in 60 – 70 % of all clinical trials worldwide. 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 15 years and has given input to numerous documents with latest activities on the “ICH Guideline E6(R3) (ICH-GCP)”.
It is our mission to effectively use the voice we have through the European CRO Federation.
We are looking forward to continuing our active involvement in the development of Clinical Trials documents.
Chair
Michael Shumilin, MD, MBA
Ukrainian Logistic Cluster, Chairman
Kyiv, Ukraine
ULC – Ukrainian Logistic Cluster
Mobile: +38 050 366 57 00
Phone: +38 044 593 06 01
E-mail: michael.shumilin@ulc-health.com
Administrative Support
Oksana Nedostup
ULC
E-mail: oksana.nedostup@ulc-health.com
Members
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:
- First publication of a Clinical Trial Logistics Glossary
- Identify the best way to guide Companies regarding applicable directives for Clinical Trial Logistics.
- Prioritise strategic initiatives and present a schedule for guidance development and deliverables for Clinical Trial Logistics
Chair
Christophe GOLENVAUX
BeCRO
E-mail: boardmember@eucrof.eu
Members
WG Chair: Christophe Golenvaux
WG Members:
- Darina Hrdličková (ACRO-CZ – Czech Republic)
- Amalia Iljasova (OCT Clinical Trials – Latvia)
- Simon Lee (CCRA – UK)
- Cristina Tatareanu (Novotech – Romania)
- Véronique Marty (AFCROs – France)
- Assia Rosati (EUCROF)
Chair
Ana-Maria Iancu
Arensia (Romania)
Members
WG Chair:
Ana-Maria Iancu
WG Members:
- Olivier Simon (VISO CLINICAL srl – Belgium)
- Carla Nascimiento (Leon Research SL – Spain/Portugal/Italy)
- Audrius Sveikata (Biomapas – Lithuania)
Chair
Ana Stojković
Svarog Research
Croatia
Members
WG Chair: Ana Stojković
WG Members:
- Marieke Meulemans (GCP Central – The Netherlands – co-chair)
- Harsha Basudev (Parexel – Italy)
- Simone Bucerius (FGK Clinical Research – Germany)
- Anamaria Dzoja Horvat (Optimapharm – Croatia)
- Cristina Florescu Moriad (AVANTYO – Romania)
- Amalia Iljasova (OCT Clinical – Latvia)
- Ana Maria Moreno Fernandez (Apices Soluciones – Spain)
- Katerina Tzagaraki (Coronis Research – Greece)
- Goran Vesov (CResT Consulting Ltd – Republic of North Macedonia)
Chair
Dolores Pérez Méndez
Sermes CRO, Spain
Phone: +34 608 505 507
Mail: dolores_perez@sermescro.com
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
Mieke Tempels
email: mieke.tempels@archerresearch.eu
Archer Research – Belgium
Members
WG Chair – Mieke Tempels
WG Members
- Antoinette van Dijk (D.O. Research – Switzerland)
- Karen Gabriels (Archer Research – Belgium)
- Natalia Gordieyvskaya (ULC – Ukraine)
- Şebnem Yaşaroğulları (Mene Research – Turkey)
Chair
Fiona Maini
fmaini@mdsol.com
(Medidata Solutions – UK)
Co-Chair
Alan Yeomans
Alan.Yeomans@pharmaconsultinggroup.com
(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
Chair
Dr Martine DEHLINGER-KREMER
ICON Plc (Germany)
Phone: +49 1738966437
E-mail: dehlingerkremerm@prahs.com
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).
Co-Chair
Jean-Sébastien Gosuin
js@curewiki.health
Curewiki (Belgium)
Co-Chair
Manika Kreka
mkreka@cvbf.net
CVBF (Albania)
Members
Co-Chair: Jean-Sébastien Gosuin
Co-Chair: Manika Kreka
Members:
- Donato Bonifazi (CVBF – Italy),
- Irina Petrova (OCT-Clinical – Latvia),
- Sarka Rozlivkova (PPD – Czech Republic).
Goals
Fostering actual & confident collaboration with patients in clinical research.
- Contribute to promote and disseminate best practices of collaboration with patients’ associations involved in study design, run and patient retention in clinical studies.
- Ease the effort of CROs having need to involve patients in national and/or international projects.
- Ensure involvement of EUCROF as a stakeholder providing consolidated CRO perspectives about the operational collaboration with patients in clinical research.
- 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.
- Create and maintain an annual observatory of patient-centricity experiences and patients associations’ expectations about clinical studies across European countries.
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
Marco Anelli
Senior Medical Advisor
Product Life Group
Corso Italia, 17 – 20122 Milano
Phone: +39 345 3396094
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.
xavier.fournie.pro@gmail.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: 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).
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
email: MalouvierAlexandre@prahs.com
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
Chair
Šárka Blažková
Manager Clinical Operations II
M: +420 728 216 207
email: info@eucrof.eu
The Task Force is there to to face the increasingly challenging situation regarding the job market for clinical research.
Goals
- Agree on a realistic minimum experience profile for CRAs to work independently
- Agree on an acceptable on the job training
- Acknowledge predefinite programmes as sufficient – pathway
WG Members
- 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
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.
