eNews January 2021

EUCROF’s Fall General Assembly (GA) took place on 3rd and 4th December 2020, as a virtual meeting due to the COVID-19 pandemic related travel restrictions. Nevertheless, it was an excellent meeting with over 40 Members, Associate Members, Partners and Affiliated member CROs connecting.

Attendees represented 17 countries: Albania, Belgium, Czech Republic, Egypt, France, Georgia, Germany, Greece, Israel, Italy, Romania, Slovakia, Sweden, Switzerland, The Netherlands, United Kingdom, and Ukraine.

Following a welcome from Dr Martine Dehlinger-Kremer, President of EUCROF, the agenda for the meeting was adopted. The meeting covered a wide range of topics including:

Summary of EUCROF Board Activities 2019/2020

Provisional Financial Situation 2020

EUCROF Achievements for the last mandate (2018 – 2020)

Working Groups update

• Clinical Trial Legislation
• Events & Training
  • Webinars held in November and December 2020
  • Podcasts
  • Access to previous Webinars and Podcasts
• Clinical Trial Centres
• New Technologies
  • eConsent
  • Archiving
  • Artificial Intelligence
• EU Data Protection Regulation: GDPR Code of Conduct
• Paediatrics
• Real World Data & Digital Health
• PharmacoVigilance

COVID-19 Pandemic – open discussion on the challenges and experiences

EUCROF Conference in Amsterdam 2020 and Madrid 2022

Presentation of Phoenix CR (Egypt), new EUCROF Partner Member

Presentation of Ukrainian Logistic Cluster (Ukraine), new EUCROF Associate Member

Vote for the new EUCROF Executive Board

Vote for Finance Audit Committee Membership

EUCROF Bylaws – Vote on motion to approve updated version

Vote for Conference SOP

EUCROF 2020-2021 Objectives and Priorities

• Proposal for the 2021 budget, including vote
• Compensation of EUCROF Administration
• Proposal for the EUCROF 2021 Budget

CRO Platform Update and CWG achievements

Location Proposal for GAs in 2021

Update on EMA’s Clinical Trial Information System

Funding Opportunities

Final Closing Remarks

Of note was that at this GA there was an opportunity for Members to decide on 7 Motions. This means that the GA was successful as a "decision-making" forum of Members, which continues to be a focus of the Executive Board and all participants.

Our sincere thanks go to all of you who attended the meeting. Thank you for your valuable contribution.

As we enter into 2021, these continue to be unprecedented times with the global outbreak of COVID-19 impacting all aspects of society and businesses. Given the widespread impact across Europe, undoubtedly all of EUCROF’s members will have been affected in some way over the last year. Throughout this time EUCROF has continued to try to assist its members as follows: -

• EUCROF supports COVID-19 Vaccine Distribution Access for Clinical Research Professionals - A letter for your respective National Health Authorities

The COVID-19 pandemic has a significant impact on our business and the continuation of clinical trials.

Now, with the approval of the first COVID-19 vaccines and commencement of their roll out, it is vitally important that we secure the role Clinical Research professionals play in clinical studies, not just those relating to COVID-19, but also critical research into other diseases and into life-threatening ones.

Communications with some of you and the clinical research sites, have highlighted a need to request that all those personnel directly involved in delivering clinical studies, at our hospitals and research centres, be considered the same as health care workers, in order to give them the same priority in the vaccination plans across each country.  This includes clinical staff, but also those staff in CROs such as CRAs who play a vital role in ensuring clinical studies are delivered in accordance with ICH GCP.

EUCROF and the global Society for Clinical Research Sites (SCRS) have prepared a letter for the respective National Health Authorities to request that CRO and site staff involved in clinical trials at sites get the possibility to be vaccinated with the first prioritised persons. Please submit the letter in your respective country to the relevant Health Authorities.

A copy of the letter was sent to the EMA (Emer Cooke, EMA Executive Director & Fergus Sweeney, Head of Clinical Studies), as well as to the European Commission (Stella Kyriakides, Commissioner Health & Food Safety), for them to be aware and support the request.

For those you do not know SCRS, they represent 10,000 research sites worldwide and serves as the unifying voice of the clinical research site community (https://myscrs.org).

Should you have any question, or need any further support, please do not hesitate to contact

EUCROF’s Secretariat at any time.

• EUCROF Website

In order to help support our members during these challenging and difficult times, a specific section for COVID-19 pandemic has been set up on our website, which provides information on new guidance in Europe (EMA (27 MS and further authorities), UK, and US (https://www.eucrof.eu/legislations-and-regulations). We hope you are continuing to find this useful.

• EUCROF Survey

As you may be aware, EUCROF undertook a survey of its members relating to COVID-19. Intense research efforts and collaboration that have already started to identify medicines for COVID-19 pandemic. Inevitably, we have EUCROF members involved in this research and, through this survey, wanted to get a better overview of how large the contribution of EUCROF is and promote this in a positive way to a broader audience.

The results were very interesting to the extent that a paper entitled ‘The current status of European research related to COVID-19 - EUCROF Survey’, has been published by Applied Clinical Trials online. The publication was prepared by Mariangela Lupo, Head of Development & Networking at CVBF - Consorzio per Valutazioni Biologiche e Farmacologiche - and Emma Akuffo, Director of Study Management at Richmond Pharmacology Ltd. as well as our President, Dr Martine Dehlinger-Kremer and Vice President, Dr Stefano Marini.

• EMA Guidance on Covid-19

The Guidance Document issued by the EMA encourages all Member States to adopt the provisions.

The most up to date information can be found at

https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/covid-19-whats-new.

• EMA publishes exceptional Transparency measures linked to COVID-19

During the COVID-19 pandemic, the European Medicines Agency (EMA) is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation.

Further information on EMA website:

https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/transparency-exceptional-measures-covid-19-medicines#comparison-with-standard-transparency-section.

• EMA published a Question & Answer on what type of studies are needed to approve COVID-19 vaccine

For more information CLICK HERE

• EMA grants conditional marketing authorisation to three COVID-19 vaccines to date

EMA’s human medicines committee (CHMP), like many other regulatory authorities across the world, has been prioritising the evaluation and is subsequent approval of a number of the leading COVID-19 vaccines. To date the EMA has approved 3 vaccines, which will be critical in our fight against the virus and enabling society to get back to some form of normality. As for all medicines, the EMA will closely monitor data on the safety and effectiveness of the vaccines, to ensure ongoing protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.

• Comirnaty (developed by BioNtech and Pfizer) is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 16 years and older. Comirnaty contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. Comirnaty does not contain the virus itself and cannot cause COVID-19.

• EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorisation. COVID-19 Vaccine Moderna contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. COVID-19 Vaccine Moderna does not contain the virus itself and cannot cause COVID-19.

• Most recently on 29 January 2021 the EMA approved the COVID-19 Vaccine developed by AstraZeneca, which is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus. COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2. COVID-19 Vaccine AstraZeneca does not contain the virus itself and cannot cause COVID-19.

You can also check EMA’s dedicated webpage on COVID-19 for the latest updates.

• The EMA and the national competent authorities (NCAs) in EU Member States have prepared a safety monitoring plan for COVID-19 vaccines.

The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed. The safety of COVID-19 vaccines will be monitored according to the guidance set out by EMA and NCAs in the good pharmacovigilance practices (GVP), that applies to all medicines. In view of the extraordinary circumstances, though, EU authorities have planned several activities that will apply specifically to COVID-19 vaccines.

In this context, EMA has also published guidance to support pharmaceutical companies’ preparation of risk management plans (RMPs) for COVID-19 vaccines. As for any medicine, companies applying for a marketing authorisation for COVID-19 vaccines must submit RMPs. The RMP explains how the company must monitor and report on the safety of the vaccine once authorised, and what measures it must put in place to further characterise and manage risks. RMPs are updated as new information becomes available.

All RMPs for COVID-19 vaccines will be published on the EMA’s website. This is part of EMA’s exceptional measures to maximise the transparency of its regulatory activities on medicines for treatment and prevention of COVID-19.

• "The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines", published in the medical journal "The Lancet" on 13 January.

Conditional marketing authorisation (CMA) is used in EU legislation for emergency situations in response to public health threats to speed up approval and save lives. This article explains in detail EMA's evaluation process that led to the recommendation of the first EU CMA for a COVID-19 vaccine. CLICK HERE for more information.

Please check EMA’s dedicated webpage on COVID-19 for the latest updates.

https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines-covid-19#medicines-undergoing-evaluation-section

Webinars organised by EUCROF’s Events & Training Working Group have continued to be highly successful in the last quarter of 2020. There were 2 webinars held in this period.

The first was entitled ‘Electronic Informed Consent … bringing the clinical trial home’ on 30 November 2020 from 2:00 PM to 3:30 PM (CET).

The presenters were Fiona Maini of Medidata Solutions, a Dassault Systèmes Company, Mika Lindroos, Signant Health Director, Product Management, eConsent and Valeria Orlova, Biomedical Sciences student at Imperial College London (undertaking a project placement at Medidata with main on decentralised clinical trials, in particular eConsent. Furthermore, the Q&A section was also supported by Jo Dewherst (PRAHS, Karen Maduschke (IQVIA) and Wolfgang Summa (Merck).

The second webinar was entitled ‘Towards the Implementation of Personalised Medicine’ on 10 December 2020 from 10:00 AM to 11:30 AM, which was our eighth EUCROF webinar for the year 2020.

The presenter was Marius Geantӑ, MD, President and Co-Founder, Center for Innovation in Medicine.

There were more than 100 attendees for these two webinars, so our thanks to all who participated and a big thank you to our speakers.

• ‘Electronic Informed Consent … bringing the clinical trial home’ Webinar Overview

This webinar on electronic informed consent (eConsent) addressed the practical considerations when implementing eConsent.  Some of the topics addressed in the presentation include:

o            Introduction and recap on eConsent

o            Decoding the ‘electronic’ in eConsent

o            COVID-19 - the eConsent catalyst

o            Stakeholder perspectives: patient, site, sponsor

o            Implementation Considerations such as:

• Process: what will you do differently with eConsent?
• Practical implementation considerations
• Financial considerations
• Regulatory landscape updates

The webinar also addressed questions and discussions highlighted after the previous webinar that was held on June 30 this year, “Electronic Informed Consent… a global perspective”, which highlighted the process of informing the patient and obtaining their consent for clinical trial participation, using multimedia training tools and eSignature capabilities, and introduced the EUCROF Implementation Practical Guide to eConsent which addresses key themes as well as hot topics and provides a view on the modernisation of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic, now sent to the EUCROF members for comments. (eConsent_Implementation_Guide_.pdf).

• ‘Towards the Implementation of Personalised Medicine’ Webinar Overview:

On 7th December 2015, the Council of the European Union, granted pan-community policy recognition for “personalised medicine for patients”, placing the theme among the EU priorities for the next decades and inviting Member States and the European Commission to engage in reaching its full potential. Personalised medicine (or personalised healthcare) aims at facilitating for the right citizen to benefit from the right prevention and treatment tools, at the right time and for the beginning, using the new validated technologies (omics, machine learning) and data (BigData, SmartData), in the context of health systems digital transformation. This is a paradigm shift from the classical “one size fits all” approach. Among the therapeutic areas, oncology, haematology, and infectious diseases benefit, to a greater extent, from the specific approach to personalised medicine. Several diagnostic tests, medicines and personalized IT solutions have been approved in the European Union. In order to reach the full potential of personalised medicine, the health systems need to transform to incorporate innovation throughout the entire healthcare continuum.

Webinar takeaways for the audience were: -

• o Understanding the concept of personalised medicine (personalised healthcare)
• o Know the main applications of personalised medicine in clinical practice
• o Understanding the role of genomics for personalised medicine
• o Understanding the policy: building blocks for personalised healthcare
• o Preparing for the future: digital twins, digital triplets, humanome.

Finally, please note that all the previous webinars are still accessible on the EUCROF Moodle eLearnIN Platform. The full list of 2019 and 2020 Webinars is posted on EUCROF website. They can be accessed at any time (EUCROF members benefit from a reduced fee).

2020 was a very busy year for the team at the EMA and each of the stakeholders participating in the development of the EU Clinical Trial Information System (CTIS). The year ended with the system entering the planned audit in December, the outcome of which will determine whether the system is ready to enter the final stages of development ahead of its implementation later in 2021.  

The CTIS high level training programme continued to be progressed with EUCROF very much at the forefront of the ongoing work. To this end, Marieke Meulemans (from GCP Central, a member of ACRON) continues to lead activities representing EUCROF and also all the industry associations ACRO, EUCOPE, EuropaBio, EFPIA, and VE. Our continued thanks to Marieke for undertaking this role and continuing the hard work and giving time required.

The programme will be organised in batches, each encompassing several modules (ca. 20) with the last batch of training materials expected to be delivered by June 2021 in order to be ready for the 'Go Live', which is currently anticipated to be from July 2021 onwards, subject to the outcome of the audit and final confirmation of a definitive implementation date by the EMA.

A summary of the Modules developed:

Module 1: Introduction to Clinical Trials Regulations

Module 2: Overview of main CTIS components and common system functionalities

Module 3: User Access Management (self-registration, login, and user profile)

Module 4: Support with workload management by workspace

Module 5: How to manage a CT

Module 6: How to evaluate a CT application (Validation)

Module 7: Management of registered users & role matrix

Module 8: How to evaluate an Initial Clinical Trial Application: Assessment and Decision

Module 9: How to search, view and download a CT in the sponsor workspace.

Module 10: How a Clinical Trial Application should be added to the CTIS and explains other application types such as adding a Member State and Substantial Modifications.

With the finalisation of Batch 2 in December 2020, 47% of the development of Training Material for CTIS, will be done.

Batch 3 is planned from January to March 2021 and now consists of 4 modules. An extra module was added focusing on the Sponsor target group and will explain the management of RFIs in the CTIS. Batch 3 represents 20% of the total volume of Training Material. After finalization of Batch 3 in March, 67% of the development is done.

Modules to be developed as part of Batch 3:

• Module 11: RFIs (new!)
• Module 12: Clinical Study Reports
• Module 13: Supervise a CT (MS)
• Module 14: MS Search, view and download a CT (MS)

On January 15, 2021 a Lessons learned session took place, in which high level comments regarding the use of Learning Goals, the method of validation and a holistic view on the modules were discussed. A comment was made that it is also of importance to include the time foreseen for revision of the modules (Q2 May / June 2021) in the planning, to ensure validation experts are available and final training material can be delivered in time.

The EMA has recently sent out a call for clinical trial sponsors to participate in the EMA CTIS Master Trainers’ Training Programme, supported by DIA as the training provider. The Master Trainers’ Programme will start in Q2 2021. CLICK HERE to apply.

The EMA CTIS Team has also published its second newsletter – “CTIS Highlights”, which is published on the page Publications/Clinical Trials Information System (CTIS) Highlights of the EMA Corporate website.

If you have any questions please contact Assia Rosati via email on This email address is being protected from spambots. You need JavaScript enabled to view it., who will direct your enquiry as appropriate.

• EMA communication: "Human Medicines Highlights" Newsletter – January 2021 issue

The latest edition of the EMA’s monthly Newsletter included decisions by their Scientific Committees and updates on medicines safety.

You can access the Newsletter by clicking here. Previous additions can also be found on this page.

• European Commission INCEPTION IMPACT ASSESSMENT for the revision of the Paediatric Regulations and the OD Regulation.

EUCROF’s Paediatric Working Group reviewed the consultation paper and Dr Martine Dehlinger-Kremer submitted comments at the beginning of January 2021.

Click here to also read comments already submitted.

• Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025

EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for the next 5 years, following its recent adoption by the HMA and EMA Management Board.

The strategy details on how the European Medicines Regulatory Network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.

“The COVID-19 pandemic has highlighted the pivotal role of medicine regulation for the protection of public health,” stated Emer Cooke, EMA’s Executive Director. “Lack of availability of medicines, either because they are not marketed or due to supply disruptions, has shown to pose serious threats to patient and animal health, animal disease control programs and sustainable livestock production. This strategy ensures that we join forces across the EU to effect tangible improvements for citizens.”

The European Medicines Agencies Network Strategy to 2025 outlines six priority areas for the network:

• the availability and accessibility of medicines.
• data analytics, digital tools, and digital transformation.
• innovation; antimicrobial resistance and other emerging health threats.
• supply chain challenges, and the sustainability of the network and operational excellence.

The network will review the strategy after 18 months to consider if the goals and objectives remain appropriate, and to adjust them if necessary, in the light of the changing environment and ongoing engagement with stakeholders.

For more details and related content please click here.

• EMA Consultation: Guideline on the clinical evaluation of anticancer medicinal products (Rev 6)

The European Medicines Agency has published for public consultation:

• Guideline on the clinical evaluation of anticancer medicinal products
• Appendix 3 to the Guideline on the clinical evaluation of anticancer medicinal products

The purpose of this guideline is to provide guidance on all stages of clinical drug development for the treatment of malignancies, including drug resistance modifiers or normal tissue protective compounds. This 6th revision addresses the most recent designs in oncology (such as umbrella and basket trials, so-called master protocols) and the emergence of indications defined in the first place by a biomarker selective for a disease sensitive to the treatment.

Whilst the thrust of a regulatory guideline should be on confirmatory studies, the aim of this guideline is also to underline the use of exploratory studies in order to identify the most appropriate target population in addition to the usual aims: to define dose, schedule, tumour type and line of therapy. The role of biomarkers to achieve these objectives is also further emphasised in this revised guideline.

Comments should be provided to This email address is being protected from spambots. You need JavaScript enabled to view it. by 15 February 2021.

• "EU Big Data Stakeholder Forum" - 15 December 2020

The agenda for this meeting was to

• Inform on implementation of the HMA-EMA Big Data Task Force priority recommendations.
• Understand stakeholders’ perspectives and priorities.
• Discuss opportunities for stakeholder collaboration.

A link to access the broadcast will be available via the event webpage.

• EMA Brexit: Industry Stakeholders webinar on the UK withdrawal from the European Union – End of Transition period – 30 November 2020

The EMA held a webinar to cover the following aspects and what to expect at the end of the Transition Period on 31 December 2020.

• EMA Operational and Procedural Preparedness update (attachment n. 1) and of the
• Updates on the Ireland and Northern Ireland Protocol of implementation (attachment n. 2)

The presentations are available and be provided upon request.

• EMA communication: First long-acting injectable antiretroviral therapy for HIV recommended for approval

EMA has recommended the granting of marketing authorisations for two new antiretroviral (ARV) medicines, Rekambys (rilpivirine) and Vocabria injection (cabotegravir), to be used together for the treatment of patients with human immunodeficiency virus type 1 (HIV-1) infection. The two medicines are the first ARVs that come in a long-acting injectable formulation. This means that instead of daily pills, patients receive intramuscular injections monthly or every two months.

The combination of Rekambys and Vocabria injection is intended for maintenance treatment of adults who have undetectable HIV levels in the blood (viral load less than 50 copies/ml) with their current ARV treatment, and when the virus has not developed resistance to certain class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrase strand transfer inhibitors (INIs).

For more details, please click here.

• Reflection paper on the pharmaceutical development of medicines for use in the older population

Please find below a link to a reflection paper on the pharmaceutical development of medicines for use in the older population

https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-pharmaceutical-development-medicines-use-older-population-first-version_en.pdf.

Following a call for candidates, EUCROF has identified a suitable applicant to take part in a research project, with the goal of mapping the CRO landscape in Europe and further. His name is Gert-Jan Dossche, a pharmacist and currently undertaking an additional master in business economics, plus following the ECCRT Junior Clinical Researcher star programme.

Contact points and deputies have been obtained from 22of our members, Associate Members and Partners and the plan is to start preparing in the coming months with the project commencing in April and running through to June. 

 Details of the role being undertaken are as follows: -

• Undertake research project, including a survey and analysis of the financial balances of the CRO companies to benchmark the CRO landscape in Europe and beyond. This could potentially form part of a master’s qualification.
• Develop the survey, including timelines, under the instruction of the Executive Board or a delegated thereof.
• Liaise with EUCROF Members to issue the survey for completion by their members and other CROs that are located in their respective countries.
• Liaise with EUCROF Members in the countries to coordinate the collection of the financial balance sheets of the companies in a harmonised way.
• Collate the data and prepare a draft report for review by the EUCROF Executive Board.
• Present the final report to the EUCROF Members at a General Assembly.
• Identify opportunities to publish the report in an appropriate journal.

Watch out for further updates in future Newsletters and EUCROF’s website. In the meantime, any queries should be sent to Assia Rosati at This email address is being protected from spambots. You need JavaScript enabled to view it..

As previously reported, EUCROF Affiliates suggested the setup of a repository of individual CRO companies and the proposed initiative was discussed and approved at the last General Assembly in December 2019. Subsequently, the Platform has now been developed and Member companies have started to populate it with their details, enabling its launch in July 2020.

Since then over 267 companies out of the 385 affiliated member CROs are registered on the platform, but many more could be included with the support of our member associations. Already the CRO platform has triggered some requests for information from visitors, which is great news. Even so, this can be enhanced as too few companies on the CRO platform are still to fully complete their profiles, which reduces their chances of generating some business interest. Actions will be taken by the Communications WG to trigger the better completion of individual company profiles.

Overall, this is an exciting initiative which we believe will be beneficial to all those companies associated with EUCROF.  We wish to thank Christophe Golenvaux, chair of the Communication WG, who is leading this initiative.

Further update will be provided in the next Newsletter. In the meantime, contact Assia Rosati via email on This email address is being protected from spambots. You need JavaScript enabled to view it. who will direct your enquiry as appropriate.