The aims and objectives of EUCROF were defined as follows:
Promote high quality
Represent the interests of CROs
Close relationship
Exchange of information
Training and educational programmes
Distribute information
Furthermore, the Federation’s objectives include:
discussions on selected topics with representatives of the pharmaceutical industry to enhance business relations and identify common concerns, support more productive discussions with European bodies (EMEA/EU Commission), and endeavour to develop transcontinental relationships with other associations e.g. with ACRO (Association of Clinical Research Organisations) in the USA and JCROA (Japanese Clinical Research Organization) in Japan.
The Federation consists of Members from 15 EU countries: Belgium (BeCRO), Czech Republic (ACRO-CZ), France (AFCROs), Germany (BVMA), Greece (HACRO), Italy (AICRO), Lithuania (Lithuanian GCPRA Association), Poland (POLCRO), Romania (ACCSCR), Slovakia (SACROP), Spain (AECIC), Sweden (ASCRO), The Netherlands (ACRON), Turkey (SAKDER) and UK (CCRA).
The Federation has also 15 Associate Members in Albania, Bulgaria, Croatia, Denmark, Latvia, Portugal, Slovenia, Spain, Switzerland (4), Ukraine and UK, as well as 6 Partner Members in Algeria, Australia, Egypt, Israel, Mexico, Pakistan and USA.
It stands for 450+ Affiliated CROs and represents 31 countries.
Since December 2006, the Federation is managed by an Executive Board (see here below) which holds monthly meetings. Each year, the Federation organizes two General Assemblies(in Spring and Fall) with all its Association Members, Associate Members and Partner Members.
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EU countries
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Associate Members
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Partner Members
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Affiliated CROs
EUCROF has 13 Working Groups
This WG was created at the beginning of 2020. The primary objective of the Clinical Trial Centres Working Group is to look for synergies between CROs and Research Sites / Clinical Trial Centres to enforce and guarantee the clinical research in Europe. It is indispensable to ensure that sites are well-prepared and within the Working Group definitions; expectations can be set, which can be of support for both CROs and Clinical Trial Centres. Through the Working Group it is also possible to represent Clinical Trial Centres and be a partner of the dialogue with European Authorities, Associations, the pharmaceutical industry and medical device representative organisations
This group focuses on any proposed changes to Regulations and Guidelines for Clinical Trials – predominantly in the EU, but also elsewhere in the world. This group actively participates public in consultations and prepares comments for feedback to the European Medicines Agency (EMA) and other regulators.
This group focuses on issues related to Clinical Trials Logistics. The CTLog WG was set up to promote international cooperation and harmonisation of medical clinical trials logistics to ensure the safety, effectiveness, and performance of clinical trials logistics worldwide.
This group is focused on the effective and timely communication to EUCROF’s Members and stakeholders of all of the Federation’s initiatives, activities and important news, to facilitate increased awareness and the achievement of its set objectives.
This group evaluates and compares current practices within the bio-equivalence studies and the Phase I studies in Europe;
This group establishes educational webinars throughout the year for its members and wider audience to provide training and increased awareness of key topics in clinical research.
This group is focused on Advanced Therapies Medicinal Products. The goal of this group is to identify, examine and provide solutions to the principal issues identified in ATMPs development and regulation, in constant dialogue and collaboration with the Industry and European Authorities.
This group provides a forum for discussion of various aspects of clinical research associated with Medical Devices and IVD. Its further objective is to interact and share experiences with other stakeholders involved in this area.
This group evaluates current and expected new technologies and evaluates how these can benefit and impact the clinical trial environment.
This group works closely with authorities, paediatric networks, and associations such as EFGCP, to improve paediatric research. The group collects and analyses information on paediatric research that it shares via trainings, publications, presentations at conferences. The group participates in initiatives set up to improve research in children and to develop better medicines for children.
This group fosters actual and confident collaboration with patients in clinical research.
This group focuses on management of pharmacovigilance services throughout the product lifecycle which are increasingly undertaken by the CRO sector for the pharma & biotech industry, including current and future best practices, as well as regulations for this critical area.
This group promotes good practices in the conduct of Late Phase studies in Europe – with particular reference to observational ones – through the sharing of knowledge, competence, expertise and skills, also speaking in congresses/conferences and participating in EMA public consultations.
EUCROF is a stakeholder of European Regulatory Authorities
EUCROF has been integrally involved in stakeholder meetings collaborating with the EMA to discuss and support the implementation of the forthcoming EU Clinical Trials Regulation. Since 2014 EUCROF has been able to work with other stakeholders to influence and shape important aspects of the planned implementation, in particular the transparency requirements of the new Regulation some years ago and in more recent years the Clinical Trial Information System. Stakeholder meetings routinely occur 3 to 4 times a year and are either face to face at the EMA’s offices in Amsterdam or via Webex and it is anticipated they will continue until at least the planned implementation of the Regulation.
EUCROF participated from the start of the development of the clinical trial portal and database (now called the Clinical Trial Information System) and was involved in the initial User Acceptance Testing (UAT) of the system. During the initial development, over fifty EUCROF testers were involved in 6 UATs during 2016, 2017 and 2018. However, in 2019 the EMA switched to a new approach progress this important project. This new approach involves an iterative and more agile project delivery model such that the project will develop and deliver functionalities through short-cycled sprints that require planning of the scope, analysis, design, development and delivery. Due to its contributions to date EUCROF was selected to have 2 Product Owners (POs) participate in the important testing activities with POs from other stakeholders’ associations.
A press release from the EMA covering its Management Board meeting in December 2019, which confirmed the Board’s agreement of an updated plan outlining the items that needed to be completed ahead of the audit of the CTIS to commence by December 2020. EUCROF POs are continuing to provide support throughout 2020 ahead of this audit.
In addition, EUCROF interacts with the EMA and contributes to several of its other initiatives. This includes providing comments on EMA Consultation papers and attending meetings and workshops. Our most recent examples are as follows: EMA Guidance Consultation
Our Clinical Trial Legislation Working Group, chaired by Dagmar Chase, has collaborated with EFPIA and other organisations to review a document issued by the EMA entitled
There was a four-week public consultation, until 23 April 2020, after which a consolidated response from all parties was submitted to the EMA. There was a large number of comments submitted, which confirmed the very high level of interest and need for guidance regarding the implications of COVID-19 on methodological aspects of ongoing clinical trials.
In addition, EUCROF’s President, Martine Dehlinger-Kremer, along with input from some members, provided input to EU Commission/EMA for the revision of the Guidance (v3) for sponsors on how to manage clinical trial during the COVID-19 pandemic. Feedback on two key issues identified for temporary regulatory flexibility:
- direct sponsor/distributor to patient IMP transfer
- remote source data verification as to not hinder market access of COVID-19 treatment or life-saving medicines for unmet medical needs.
- EMA’s Regulatory Science Strategy.
The EMA published its strategy in March 2020. It provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines, that combine different technologies. The ongoing COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy. The learnings from the handling of this public health crisis will be incorporated, so that we can adapt our process in real-time, where needed.
The strategy sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary.
The document identifies strategic goals for such engagement for human and veterinary medicines and proposes core recommendations and underlying actions to support these.
EUCROF’s President, Dr Martine Dehlinger-Kremer, attended two workshops to discuss and contribute to the draft strategy prior to its publication.
Martine Dehlinger-Kremer
President
Germany
Yoani Matsakis
Vice-President
France
Simon Lee
Secretary
UK
Sverre Bengtsson
Treasurer
Sweden
Christophe Golenvaux
Member
Belgium
Helena Lüning
Member
Sweden
