eNews October 2020

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 few months. EUCROF has continued to try to assist its members as follows: -

• 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 and further authorities (27 MS, 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. Thank you to all those who managed to complete it.

The results were very interesting to the extent that a paper is to be published entitled ‘The current status of European research related to COVID-19 - EUCROF Survey’, 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 communication: COVID-19: EMA meetings with delegates and experts will be held virtually until end of December 2020

EMA has taken steps to reduce the further spread of COVID-19, with the aim of protecting staff, delegates and experts and playing their part as responsible citizens in the host country, the Netherlands.

Until the end of December 2020, EMA is hosting all committee and working party meetings virtually. It is postponing stakeholder events or holding them virtually.

As of 16 March 2020, most EMA staff are working remotely. These measures are in line with the steps taken by the European Commission and the Dutch Government’s coronavirus containment efforts.

These measures do not impact EMA’s core activities related to the evaluation and supervision of medicines. EMA is continuously reviewing and adapting these measures as necessary.

• EMA review of early data on COVID-19 vaccines

EMA’s human medicines committee (CHMP) is assessing all the applications for COVID-19 medicines under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks.

EMA is assessing COVID-19 medicines in accordance with its usual standards for quality, safety and effectiveness.

COVID-19 vaccines

The CHMP is evaluating preliminary data on two COVID-19 vaccines using its rolling review procedure:

AZD1222 being developed by AstraZeneca, in collaboration with the University of Oxford and BNT162b by BioNTech, in collaboration with Pfizer.

The rolling review of these vaccines began with CHMP evaluating the first batches of data and will continue until enough evidence is available to support a formal marketing authorisation application.

EMA cannot reach a conclusion on the safety and effectiveness of these vaccines until the developer has submitted this evidence and EMA has assessed it.

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.

The most recent was on the topic of “Computerized System Validation in Clinical Research” on Wednesday, the 16^th of September, which was our sixth EUCROF webinar for the year 2020.

The presenter was Marieke (M.A.) Meulemans, M.Sc, CEO and Founder of GCP Central B.V.

There were an excellent 88 attendees for this webinar, so our thanks to all who participated and a big thank you to our speaker.  

Webinar Overview:

Software is used widely in clinical trials: from managing worldwide trials, to finding and scheduling patients, gathering trial data, and analysing trial results. How is the quality of the computerised systems ensured? And how do we know the data generated by these systems is reliable and robust?

Validation of software ensures that clinical data generated by these systems is done in a structured way and ensures integrity, reliability, and robustness of the generated data.

In this 1-hour webinar, attendees learnt why computerised systems must go through a validation process when used in clinical trials, as well as the consequences of failing to validate your systems. The requirements for validation were explained, who is responsible and when it is necessary. Through the speaker’s experience, attendees learnt the why, what, and how of validation with regards to regulatory requirements.

This webinar also provided attendees with a walk through the process of system validation and its key deliverables. Finally, attendees were shown the way to either manage the validation process of their own system or make the right considerations when selecting software for their clinical trials.

Webinar takeaways for the audience were: -

1. Understand for which software validation is required and in which regulations requirements for validation are documented;

2. Understand who is responsible for validation and what the goal of validation is;

3. Know what to look for when choosing a software to be used in a clinical trial;

4. Understand what steps should be taken to validate a (vendors’) system;

5. Be aware of the challenges in the validation process and know how to ensure a smooth process.

Despite the challenges presented by the COVID-19 pandemic, this year continues to be very busy for many who have been representing EUCROF at multiple meetings across a number of topics. Our thanks to all those who have represented EUCROF during the last quarter.

• EMA-GCP IWG virtual meeting with interested parties on the topic “Artificial intelligence in clinical trials – ensuring it is fit for purpose” on 22nd September 2020. EUCROF were represented by Alan Yeomans and Bruno Boulanger, with the latter proving the presentation.
• EMA, EU CT Information System Stakeholders Meeting, on 23rd September 2020. This was a teleconference where EUCROF was represented by Dr Martine Dehlinger-Kremer (EUCROF President), Simon Lee (EUCROF Secretary) and Dagmar Chase (Chair of the CTL WG)
• Enpr-EMA meeting - industry/CRO update on 28th September. This was a virtual meeting and Dr Martine Dehlinger-Kremer gave a presentation on COVID-19 impact on paediatric clinical trials / CRO perspective
• EFGCP/DIA Paediatric Conference "Better Medicines for Children" on 12 - 13 October 2020. Dr Martine Dehlinger-Kremer, who is a member of the programme committee, attended.
• European Commission meeting on preparation of guidance on Substantial Modification and IMPD on 21 October 2020 was attended by Dr Dagmar Chase and partially by Dr Martine Dehlinger-Kremer.
• 25 Years of EMA meeting: building, learning and adapting to new challenges. To this virtual meeting with stakeholder’s attendance only upon invitation was attended by Dr Martine Dehlinger-Kremer and Dr Stefano Marini on 22 October 2020.
• At the Gianni Benzi Foundation XIII Foresight Training Course - Challenges for Researchers and Regulators facing the pandemic crisis on 23 October 2020, Dr Martine Dehlinger-Kremer help a presentation on: "Impact of COVID-19 on Clinical Trials. New approaches that can be taken for future trials".

• EMA communication: "Human Medicines Highlights" Newsletter – October 2020 issue

We are pleased to send you our latest edition of the monthly Newsletter, which includes decisions by our Scientific Committees and updates on medicines safety. We hope that you will find this useful and welcome any feedback.

You can access the Newsletter by clicking here.

• EMA 25^th anniversary virtual symposium: New approaches in patient-focused cancer drug development on 29th October 2020

The European Medicines Agency will host a symposium to explore themes such as the natural evolution of patients’ role from interested stakeholders to advisors and decision makers, evidence-based methods of patient preference data collection. In addition, topics, such as collaborative research networks and registries for real-world data generation, also in difficult areas, including rare cancers and palliative care, will be discussed.

The Agency shares the European Commission priorities of improving cancer prevention and care, and fully appreciates the opportunities brought by the rapid scientific and technological advances, but also the challenges that these will bring.

Coupled with the digital transformation that features in many Commission policy areas, such as big data and digital platforms, there is a real opportunity to develop the impactful actions in the area of health data to speed up development and optimisation of cancer treatments, while, at the same time, augmenting data generation to satisfy the evidentiary standards of patients, clinicians, regulators and payers.

A live broadcast will be available during the event.

Should you have any questions on the content of the event, please contact via: This email address is being protected from spambots. You need JavaScript enabled to view it.

• EMA consultation: ICH guideline Q3D (R2) on elemental impurities - Step 2

The European Medicines Agency has published for public consultation a revised draft of the ICH guideline Q3D (R2) on elemental impurities - Step 2.

Comments should be provided using a template and sent to This email address is being protected from spambots. You need JavaScript enabled to view it. by 18th December 2020.

• Recommendations by the Enpr-EMA working group on trial preparedness for sponsors, principal investigators and triallists involved in paediatric clinical trials:

‘Preparedness’ is the structured assessment of contributing factors that enable the smooth conduct of clinical trials in a timely manner.

The recommendations cover the following areas:

• Collecting relevant data and information;
• Involving contributors, such as clinical-trial sites, expert groups, patients and their families, and regulators;
• Following a structured approach;
• Using appropriate resources;
• Approaches for preparing plans and studies.

Enpr-EMA published the recommendations on 31 Aug 2020. The final recommendations take account of feedback from stakeholders received via a public consultation in 2019.

https://www.ema.europa.eu/en/documents/other/preparedness-medicines-clinical-trials-paediatrics-recommendations-enpr-ema-working-group-trial_en.pdf

• EMA consultation: ICH E14/S7B Implementation Working Group: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Questions and Answers

The European Medicines Agency has published for public consultation a revised draft of the ICH E14/S7B Implementation Working Group: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Questions and Answers.

This document comprises:

• Revisions proposed to sections 5.1 and 6.1 of the current Q&As for ICH E14. Other sections are not proposed for revision.

Subsequently, at Step 4, the revised sections 5.1 and 6.1 will be integrated with the other current Q&As for ICH E14.

• New Q&As for ICH S7B.

           Comments should be provided using a template and sent to This email address is being protected from spambots. You need JavaScript enabled to view it. by 28th November 2020.

• EMA communication: Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21

The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan, which sets actions to be delivered in 2020-21. With the European Medicines Regulatory Network focused on the response to the COVID-19 pandemic, the workplan aims to progress evolution to data-driven regulation through smart working, leveraging collaboration with stakeholders and the use of remote expert workshops.

In the past three years, EMA and HMA have led a thorough assessment of the challenges and opportunities posed by big data in medicines regulation. This culminated in January 2020 with the publication of recommendations for regulators to evolve their approach to data use and evidence generation.

Following this preparatory work, the Big Data Steering Group was established in February 2020 to advise the EMA Management Board and HMA on implementing ten priority recommendations.

The work carried out by the Big Data Steering Group builds on the Regulatory Science Strategy to 2025, published in March 2020, and will support the European Medicines Agencies Network Strategy to 2025, currently under development.

For more information on Big Data, please click here.

• EMA Workshop on support for orphan medicines development

The EMA will hold a Workshop on Support for Orphan Medicines Development via broadcast on 30th November 2020.

This virtual event aims to encourage early and efficient interactions with the regulators by highlighting pre-marketing support in medicine development in rare diseases. Existing tools such as orphan designation, protocol assistance and PRIME scheme will be highlighted and explained in the context of early product development strategy.

Stakeholders will have an opportunity to express their views in relation to early medicine development and regulatory interactions.

The workshop is targeted at small to medium enterprise medicine developers, academia, patients, healthcare professionals and ERNs who are often at the forefront of medicine development in rare and neglected diseases.

To register go to:

https://ec.europa.eu/eusurvey/runner/OrphanMedicines_workshop_30November2020

For more information, please contact: This email address is being protected from spambots. You need JavaScript enabled to view it.

The EUCROF Events & Training Working Group is happy to share with all of you the second EUCROF podcast "Validation of Computerised Systems in GCP Environment " prepared by Simone Bucerius and Günter Wölfl, both of FGK in Germany. This second EUCROF podcast can be viewed on the Latest News section on our website:

https://www.eucrof.eu/news-eucrof/latest-news

and our LinkedIn channel

We would be happy if you wish to share the info with your contacts.

Further such Podcast will be released in the coming months and our thanks to the Events & Training WG for its efforts in proposing this important new form of communication.

·       Creation of EUCROF Working Group - Clinical Trial Centres

It is with pleasure that we would like to share with you that earlier this year a new Working Group on Clinical Trial Centres has been created within EUCROF.

Within Clinical Research the Investigators and their Investigational Sites are crucial stakeholders and in the last years their importance has been increasingly recognised. For CROs it is of major importance to have a valid and professional counterpart at the Investigator level. Furthermore, the creation and maintenance of a well-organised structured and financial sustainable Site is of an advantage. Within clinical development and research, the constraints and expectation about the level of preparedness and expertise of Sites continue to grow; an increase of complexity of trials, different recruitment techniques, technical requirements with the financial consequences are continuously and rapidly moving forward. For CROs it is indispensable that the Sites keep up with the speed of progress, their continuous development and progress is enabling CROs to continue to deliver their services in the complex environment of clinical research. But it is a mutual obligation for all parties to make this happen and be successful.

The primary objective of the Clinical Trial Centres Working Group will be 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, therefore within the Working Group definitions and expectations will be set, which can be of support for both CROs and Clinical Trial Centres in this regard. Through the Working Group it will also be possible to represent Clinical Trial Centres and be a partner of dialogue with European Authorities, Associations, the pharmaceutical industry, and medical device representative organisations.

The new European Clinical Trial Regulation, Medical Device Regulation and Risk-based monitoring strategies hybrid protocol models, the COVID pandemic are only some of the recent environmental changes which require an increased level of investments and preparedness of the research sites. At the site level, a higher level of organisational infrastructure, availability of professional workforce and technical capabilities are needed. It will be essential for EUCROF to play an important role in participating in the discussions and development of the investigational sites through a Working Group dedicated to Clinical Trial Centres.

The Working Group is led by Antoinette van Dijk as Chair and Vivienne van de Walle co-Chair. Representatives from various other countries like France, Belgium, Turkey and Germany have already joined and the WG is looking forward to enlarging their team in the next upcoming months.

• Invitation to join EUCROF’s Working Group on Real World Data and Digital Health

The recent transformations in the clinical research landscape have prompted the EUCROF’s former “Late Phase” Working Group to rename itself into the “Real World Data and Digital Health” WG.

The main reasons behind this change is the fact that real-world evidence is no longer restricted to post-marketing studies and is used all throughout the drug development cycle. For example, in the field of rare diseases, natural history of disease studies may be needed even before a drug candidate is selected (the so-called “Phase 0”) and real-world data are now accepted as endpoints for approvals or label changes by European and American regulatory authorities.

Another major game-changer has been the generalisation of real-world data generation though connected devices or apps. The most recent manifestation of this revolution is the implementation of fully decentralised studies, mixing data from secondary sources like electronic medical records with primary data collected via real-time digital tools.

The working group is looking for new members working in the RWD field and willing to participate in new projects aimed at developing and promoting this field of research with the highest standards among the different actors of clinical research: CROs, Pharma and Biotech companies, Medical Device companies, and Regulatory Authorities. In the past, the WG has authored white papers and made presentation in conferences and it has also taken part in discussions with authorities as matter experts.

If you are actively working in the field of RWD and you are willing to regularly dedicate some time to the promotion of such a field of research, please send to the Chair of the WG, Alexandre Malouvier, your CV along with a short text detailing your motivations and what you are willing to bring to the team (This email address is being protected from spambots. You need JavaScript enabled to view it.).

The WG meets every month via TC and, and in the past, it managed to have a face-to-face meeting per year.

If you know someone in your organization who would be interested in this role, we are kindly asking you to forward them this invitation.

• Invitation to join the Pharmacovigilance WG

Nicolas Tsiakkas is the Head of the Pharmacovigilance Working Group of the European CRO Federation (EUCROF), i.e. the EUCROF Working Group representing the CROs offering pharmacovigilance services to the industry, is looking for more members to join.

The purpose of this communication is to make the existence of such a working group known to all European CROs offering pharmacovigilance services and to call for interest in joining the group as active members. The main area of involvement is post-marketing pharmacovigilance, but the group is also experienced in clinical trial pharmacovigilance.

Over the past years, the group has contributed to various community activities, including comments on proposed EU guidelines and regulations, interacting with the EMA, national agencies and scientific communities, such as ENCePP or DIA, as well as publishing, speaking at or chairing various conferences. Participating in the Pharmacovigilance Working Group is also a unique and stimulating opportunity for sharing cross-border experience and expertise with senior executives, staying updated and anticipating an evolving environment.

The group can look back on a considerable amount of achievements. However, the WG knows that it could offer even more to our CRO community if it grew and became more visible. In addition, the WG lacks representation in Eastern Europe, which is currently a very dynamic and successful region in pharmacovigilance.

If you or a member of your team have a profound experience in drug safety and can dedicate some time on a regular basis for contributing to such a group, please send the Chair, Nicolas Tsiakkas (This email address is being protected from spambots. You need JavaScript enabled to view it.) a short CV indicating your experience in the field of pharmacovigilance.

EUCROF has issued a call for candidates to come forward to take part in a research project, with the goal of mapping the CRO landscape in Europe. Details of the role 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. 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 harmonized 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.

The candidate needs to have

• Strong coordination skills
• Good understanding of company financial data
• Background in life science is an asset

Completion of the work will be within an agreed timeframe which is anticipated between 3 and 6 months.

Interest in this role should be sent to Assia Rosati at This email address is being protected from spambots. You need JavaScript enabled to view it. no later than 4^th November 2020.

On 29th September, EUCROF has successfully submitted an application in response to the IMI2 CALL 23 Topic 1 “Returning Clinical Trial Data to study participants within a GDPR compliant and approved ethical framework”. The “Data2Patients” (D2P) project, coordinated by the European Patients Forum (EPF), was composed by 21 Partners from 10 Countries with specific expertise to develop a patient-centred, participative and sustainable framework to return clinical data to patients and harmonise it with local and pan-European legal, ethical and regulatory context. Results of the first stage of the proposal will be communicated by the end of the year.

D2P proposes to develop and operate a pan-European trusted digital space where patients will be empowered with a personal digital "Patient Locker". A decentralized blockchain infrastructure will enable peer to peer standardised data exchanges between the Patient Locker of a patient and the other clinical research systems or Electronic Health Records at the hospital sites involved in a research programme, provided that they have been certified to join this trusted digital space. Moreover, a GDPR Code of Conduct, approved by all the Data Protection Authorities of the EU Member States, the EDPB and the EC, will establish a transparent and harmonized pan-European governance and legal frame, where patient representatives will be in decision making position alongside with the other stakeholders.

This is an important step for EUCROF, and we hope to be able to update you in the next Newsletter on progress. 

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 250 companies out of the 385 affiliated member CROs are identified on the platform but many more could be created 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.