eNews April 2020

These are clearly 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. EUCROF has been trying 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), US (https://www.eucrof.eu/legislations-and-regulations). We hope you are finding this useful.

• EUCROF Survey

Furthermore, we decided to undertake a survey of our members relating to COVID-19. With this in mind, you have recently received an email asking you to complete a short survey on COVID-19 with a deadline for completion by 27 April. 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. I hope you found time to complete it and we will be looking at the data in the coming days, so look out for an update on our website.

• EMA Guidance Consultation

Our Clinical Trial Legislation Working Group chaired by Dagmar Chase have collaborated with EFPIA and other organisations to review a document issued by the EMA entitled

Submission of comments on 'Point to consider on implications of Coronavirus diseases (COVID-19) on methodological aspects of ongoing clinical trials' (EMA/158330/2020)

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 just goes to show the very high level of interest and need for guidance regarding the implications of COVID-19 on methodological aspects of ongoing clinical trials.

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

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.

For more information on the above please email via This email address is being protected from spambots. You need JavaScript enabled to view it.

EUCROF held its 5th European Conference on 10 – 11 February 2020 in Amsterdam, The Netherlands.

To establish and run this Conference, EUCROF collaborated with both ACRON and BeCRO, the national associations of the Netherlands and Belgium.

As with previous conferences, there was an extensive programme of presentations, covering many key topics facing our industry today, all presented by leading speakers on each topic.

We were pleased that this turned out to be our most successful Conference so far with more than 320 attendees, who, from the feedback we received, found the meeting and the content to be very beneficial and highly informative.

The EUCROF Executive Board would like to thank all those who worked so hard before and during the Conference to make it such a success. Particular thanks go to Darina Hrdličková (Chair of the Organising Committee) and Michèle Garot (Chair of the Programme Committee) and each member of these Committees.

The next Conference will be in Madrid in February 2022 and planning will commence in the near future. Look out in future newsletters for updates.

One of the lessons learnt during our last Conference in Amsterdam was how important it is to effectively coordinate the communication to promote the event. As a result, EUCROF will set up a Communication Committee, which should take care of the communication and promotion of the conference. We are, thus, looking for candidates for the new Communication Committee.

Any of the EUCROF Members, Associate Members and Partners may designate candidates for the Organising, Programme and Communication Committees.

In case you intend to propose a candidate, please apply directly to our Secretariat at This email address is being protected from spambots. You need JavaScript enabled to view it. by 15 May 2020 at the latest, in order to have a list of candidates by the Spring GA, on 4 – 5 June 2020.

When applying, please keep in mind the following:

a) What matters above all, is the success of the conference

b) Contribution to the Conference does not absolutely require to have one representative in any of the 3 Committees

c) Participation to the Committees means that the candidate commits to actively contribute to the activities of the related Committee

Members will be informed by the end of June whether their proposal/candidate has been accepted.

Following on from a highly successful year for webinars, effectively organised by our Events & Training Working Group, since our last Newsletter we have held our first two webinars, both or which were highly successful.

The first webinar on 25th February was entitled “The Patient Centricity Effect – How it benefits Patients, Sites and Sponsors – Practical cases from paediatric studies”. The presenters were Rosamund Round, Vice President, Patient Innovation Center, Parexel International and Mariangela Lupo, Patients Advocacy Manager TEDDY European Network of Excellence for Paediatric Clinical Research. Our thanks to both for an excellent webinar.

Webinar Overview:

Patient centricity has become something of a buzz phrase over the last few years. However, behind the name, a concept that offers real value can be found. Such benefits were discussed during this webinar, highlighting:

• Results from recent research that quantifies the positive business impact to sponsors by taking a patient centric approach;
• Exploration of real examples where the patient has benefited from being put at the heart of clinical research,
• Advantages experienced by sites when patients are central to study planning and implementation.

This informative session provided attendees with data and examples they can bring back to their own organisation, in order to support the development and growth of patient centric practices. Furthermore, a collaborative discussion about the future of patient centricity and its effects on the industry completed the webinar. Moreover, the webinar provided practical examples on how to involve children in clinical trials. A child-friendly approach is necessary not only in the daily clinical practice, but throughout the research and development process, from setting research priorities, involvement in research design and planning, research conduct to dissemination and communicating research findings. In case of studies involving children, age-tailored information booklets, assent forms and summaries of the results should be written in age-appropriate, simple and understandable language to ensure ease reading by parents and children. Moreover, the investigators should obtain agreement from the child in addition to informed consent of his/her parents, even when such an agreement is not mandatory by law.

An innovative approach for the patients’ involvement in paediatric clinical research is represented by the Young Persons Advisory Groups, an organization composed of youths, patients and carers actively participating in clinical research and advising researchers and their teams.

The second webinar on 28th April was the most successful webinar we have held with over 150

participants!!

It is entitled ‘Traceability in Clinical Trials: Challenges of the new EU TMF/eTMF Guideline’ and the presenter was Dagmar Chase - GCP Consultant and Trainer, Clinrex Munich (Germany).

Webinar Overview:

Since June 2019, a new EU Guideline on paper and electronic Trial Master File (TMF) is in effect. The Guideline offers clarifications in many aspects. For example, the requirements on electronic TMFs (eTMFs) are clearly stipulated and the essential documents listed in ICH-GCP are supplemented by additional important documents. Emphasis is given to the interface between sponsors and CROs, by providing many elements that should be present in either contractual agreements or other documents that describe the cooperation between the parties. Sponsor oversight duties are well explained, so are the responsibilities of investigators. The structure of a TMF is presented by introducing a primary TMF, plus other parts of the TMF, which belong to central systems. A TMF is clearly following a decentralised structure, which poses challenges to all involved parties of a clinical trial. Last but not least, retention of essential documents is covered and requires the archiving of data in such a way that the data is maintained either in the original system, an emulated system or is migrated to a new system. Static data is not acceptable. Are we really able to fulfil these requirements?

This webinar offers an overview of the EU Guideline on TMF/eTMF and familiarises the audience with the important topic of traceability in clinical trial. The webinar encompasses the building of the TMF in the right structure, making it available when necessary and archiving it in such a way that inspectors will be satisfied.

EUCROF representatives have continued to be heavily involved with the EMA’s activities to develop the Clinical Trial Information System, a prerequisite to enable the EU Clinical Trial Regulation to be implemented.

Again, in the last 3 months, since our last Newsletter, EUCROF, through Ingeborg Boddeke, who acts as EUCROF’s Product Owner, has been involved in multiple weekly calls, as well as a meeting with the European Commission as part of the audit readiness assessment and on-site Sprint testing of version 11 of the software.

1. As you might have seen from a recent email, Ingeborg has had to withdraw from being a Product Owner, due to her own increasing work commitments. Our thanks to Ingeborg for all of her effort and commitment over the last few years. EUCROF still has two PO positions available to it so, we are now seeking to find another person with the appropriate credentials to replace Ingeborg during the next crucial phase of the project, leading up to the audit and then ‘Go Live’. It is essential that the PO have sufficient available time of at least 12 hours per week to dedicate to calls and meetings
2. a good mindset of being a team player and collaborator with a clear understanding of representing then stakeholders ahead of their own employer and
3. an in depth understanding of the EU Clinical Trial Regulation, in order to apply this to the development activities.

If you are interested, please speak to your manager and your national association before applying to EUCROF Secretariat at This email address is being protected from spambots. You need JavaScript enabled to view it. before the 15 May 2020.

If you have any questions then 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.

• COVID-19

EMA and its partners in the European medicines regulatory network are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the European Union (EU). No reports of current shortages or supply disruptions of medicines marketed in the EU due to this outbreak have been received at this point. As the public health emergency develops, shortages or disruptions cannot be excluded.

The EU (EMA, the European Commission and national competent authorities in the Member States) have organised the first meeting of the EU Executive Steering Group on shortages of medicines caused by major events to discuss measures aimed at addressing the impact of the outbreak of COVID-19 on the supply of medicines in the EU. The mandate of this group is to provide strategic leadership for urgent and coordinated action within the EU in case a crisis caused by major events, such as the COVID-19 outbreak, risks impacting the supply of medicinal products for human and veterinary use.

In the context of COVID-19, the group will identify and coordinate EU-wide actions to protect patients when medicines in the EU are at risk of supply shortage, e.g. due to a temporary lockdown of manufacturing sites in areas affected by COVID-19 or travel restrictions impacting shipment. The group will also ensure that patients and healthcare professionals across the EU are kept informed in a consistent and transparent manner about the risks and the remedial actions taken.

For more information on the EU Executive Steering Group and the actions already taken, please click here.

• In January the EMA published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.

Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases. In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a new active substance which had never been authorised in the EU before. The infographic includes a selection of medicines that represent significant progress in their therapeutic areas.

Once a medicine is authorised by the European Commission and prescribed to patients, EMA and the EU Member States continuously monitor its quality and benefit-risk balance and take regulatory action, when needed. Measures can include a change to the product information, the suspension or withdrawal of a medicine, or a recall of a limited number of batches. An overview of some of the most notable recommendations is also included in the document.

For more information on the evaluation and authorisation of medicines, please click here.

• The EMA has sent out its latest editions of the monthly Newsletter, which includes decisions by our Scientific Committees and updates on medicines safety.

You can access the Newsletters by clicking here.

• EMA, the Heads of Medicines Agencies (HMA) of EU Member States and the European Commission (EC) have published, on 29th January, key principles outlining a harmonised approach to develop and use electronic product information (ePI) for human medicines across the European Union.

The key principles derive from extensive discussions and consultations carried out in 2018 and 2019 by EMA, HMA and the EC, with representatives of all stakeholder groups concerned, from patients, healthcare professionals and regulators to the pharmaceutical industry.

More information is available in today’s press release on the EMA website.

• The European Medicines Agency has released for public consultation the reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders.

This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies. While it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products themselves, the current European Commission (EC) guide to GMP (hereafter referred to as the ‘GMP guide’) refers, in several places, to MAHs and their responsibilities in relation to GMP.

This Reflection Paper seeks to provide clarity as to what the various responsibilities are and what they mean for MAHs at a practical level. In addition to the MAH responsibilities in the GMP guide, this paper also addresses the various legislative provisions (i.e. in European Directives and in other guidelines), which relate to GMP and which concern MAHs.

The draft paper is available by clicking here. Comments should be provided using this template and sent to This email address is being protected from spambots. You need JavaScript enabled to view it. by 17 April 2020.

• EMA has published its Regulatory Science Strategy to 2025 in March.

The strategy 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 the draft strategy prior to its publication.

For the press release and related content, please click here.