Dear Members, Associate Members, Partners and All,
As we start a new decade, I am very happy to present, together with the EUCROF Board, our first EUCROF Newsletter of 2020, reviewing activities in the period October to December 2019 and looking ahead at what is planned in early 2020. As you will see, EUCROF and its representatives have had an intense period up to the end of 2019.
The first topic I wish to highlight to you all is our 5th European Conference on Clinical Research that will be held in Amsterdam on 10 and 11 February 2020. Registration remains open so, if you have not registered yet, please do so together with colleagues and join us for what plans to be another very attractive Conference. As you will see, the programme as always is very strong, covering important hot topics with excellent and well-recognised speakers from the authorities, pharma/ biotech, CROs and patients’ associations. We are looking forward to meeting you there.
Since the last eNews in October 2019, EUCROF and its members have been involved in numerous activities and initiatives. We held our General Assembly in Milan, which was attended by almost all of our members. It was excellent to see so many attendees be present and ensured the meeting covered most of the key topics EUCROF is focused on at this time, including setting out our objectives for 2020. My sincere thanks to the Italian Association, AICRO for their preparations and hospitality, which made the General Assembly such a resounding success.
In recent months, EUCROF has continued to make positive steps with its plans to establish a Code of Conduct for the Clinical Research sector, relating to GDPR. We are having many positive discussions and gaining support from several interested industry stakeholders. External parties from pharma, CRO, ethic committees as well as patient associations are reviewing the draft at present and I am sure more exciting news will follow in the coming months.
We have continued with our collaboration with the EMA initiatives and attended a stakeholder meeting in Amsterdam, where we received an update on the development of the Clinical Trial Information System. In December the EMA Management Board announced that the audit of the system is planned to start by the end of December 2020. In the meantime, our representatives will continue to work diligently with the EMA counterparts to make this project a success. My thanks as always to all those concerned for their continued commitment.
In summary EUCROF’s influence is growing across many aspects of Clinical Research.
I wish you a happy reading and successful start to 2020 and thank you in advance for your continued contribution to our success!
Dr Martine Dehlinger-Kremer
EUCROF President
EUCROF’s winter General Assembly (GA) took place on 5th and 6th December 2019 at the Fondazione Stelline – Corso Magenta 61, Milan (Italy), hosted by the Italian Association of CROs (AICRO), the EUCROF member from Italy. It was a well-attended GA with 30 attendees present and with others joining by telephone over the two days of the meeting. Attendees represented 15 countries: Belgium, Czech Republic, France, Germany, Greece, Italy, Romania, Slovakia, The Netherlands, United Kingdom, Albania, Georgia, Spain, Algeria, and Israel. [ARo: I placed the countries in alphabetical order, starting with the Members first, then the Associate Members, then the Partners. Do you think it can work this way, or would it be better to stick to a strict alphabetical order, that would be: Albania, Algeria, Belgium, Czech Republic, France Georgia, Germany, Greece, Israel, Italy, Romania, Slovakia, Spain, The Netherlands, United Kingdom?]
Following a welcome from Dr Martine Dehlinger-Kremer, President of EUCROF, and the hosts Dr Donato Bonifazi (President of AICRO) and Dr Stefano Marini (Treasurer of AICRO), the agenda for the meeting was adopted. The agenda covered a wide range of topics including:
Summary of EUCROF Board Activities 2018/2019
Provisional Financial Situation 2018
Working Groups update
EU Data Protection Regulation: Code of Conduct
EUCROF Conference in Amsterdam 2020 and Madrid 2022
Presentation on AICRO
Vote for Associate Membership incl. motions on attending GAs, Advertising EUCROF Affiliation
Database with CRO Affiliates
EUCROF 2020 Objectives and Priorities
Proposal and vote for 2020 budget
Presentation of New EUCROF members
Webinars in 2019 and planned for 2020
Start-up delays and cancellation of CTs
Location Proposal for GAs in 2020
Financial Policy
EU Survey Opportunity
AOB & Conclusions
Of note was that at this GA there was an opportunity for Members to decide on 12 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 the Italian Association AICRO for hosting the event in Milan.
Last year, 2019, proved to be our most successful year to date for webinars thanks to the efforts of our Events and Training Working Group, together with the presenters who gave their time to deliver their particular webinars.
Overall, there were a total of 5 webinars with 230 attendees. The webinars covered a range of topics relevant to our industry including:
‘Doing more with Data: Data Anonymisation and Pseudonymisation under the GDPR’ (April 2019), ‘Understanding the Crisis around the P-Values: Statistical Methods for the 21st Century (May 2019), Risk-based and Remote Monitoring (July 2019) and GDPR and CTR interplay, One Year Later. Understandings and Questionings’ (Sept 2019).
The 5th and final webinar for 2019 was as follows:
“Validation of Computerized Systems in GCP Environment”.
The presenters were Simone Bucerius, Quality Assurance Manager, FGK Clinical Research GmbH and Guenter Woelfl, e-Solution Manager, FGK Clinical Research GmbH.
Webinar Overview:
This webinar gave a general overview of validation procedures focusing on validation processes of non-configured (GAMP category 3) and configured (GAMP category 4) products. To illustrate this, the presenters played through the validation steps with the help of an example. Furthermore, the presenters introduced relevant guidelines and typical roles and responsibilities in validation as well as looking at what they had learned so far from audits and inspections.
Plans for the webinars that will take place in 2020 are now being finalised with the first already planned for next month (see Forthcoming News). For further details or even proposing a webinar please contact Donato Bonifazi at This email address is being protected from spambots. You need JavaScript enabled to view it. (Chair of the Events and Training Working Group).
If you are interested in attending a webinar then please contact Assia Rosati via email on This email address is being protected from spambots. You need JavaScript enabled to view it., and/or take a look at the EUCROF website https://www.eucrof.eu/webinars. Please, be aware that in case you missed any webinar of your interest you can still attend them remotely through the EUCROF Moodle platform at https://elearnin.cvbf.net. For registration send an email to This email address is being protected from spambots. You need JavaScript enabled to view it..
As you are aware, EUCROF has numerous Working Groups made up of members and experts in specific fields of Clinical Research. CLICK HERE to go to our website for more information on each of these WGs. However, in this edition we are pleased to present an update on the activities of one particular WG, namely the New Technologies WG, which has a particular focus on Archiving and the development of a Code of Conduct, covering the requirements of the General Data Protection Regulation. A summary is as follows:
Archiving:
- Alan Yeomans presented at the 3rd EU QA Conference in Dublin on 6th November 2019. Approximately 150 people attended, and the response was very good. Pictures and comments from the presentation were posted on LinkedIn by one of the attendees. For more information CLICK HERE.
- Thierry Lepoutre presented at the Data Management Biomedical (DMB) Conference in Paris on November 19th. For more information CLICK HERE.
Code of Conduct:
- On behalf of the WG, Gunnar Danielsson (retired EMA GCP inspector) presented the effect of GDPR on clinical research at the 7th Conference on Clinical Trials in the Nordic Countries in Oslo on 18th November 2019. The presentation was well received and contained several slides introducing the Code of Conduct work being performed by the WG and referenced the EUCROF Conference in Amsterdam 2020. This presentation was largely based on the webinar held by Thierry earlier in the year, with some modifications.
For more information 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.
EUCROF representatives continue 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. This takes up considerable time and EUCROF’s sincere thanks go to Ingeborg for her commitment in providing valued input to this project.
You may have already seen the press release from the EMA, covering the EMA’s Management Board meeting of December 2019. At this meeting, the Board agreed an updated plan which outlines the items needed for the audit of the CTIS to commence by the end of December 2020. To see the full press release, CLICK HERE.
We will keep you all posted in future Newsletters, but in the meantime if you have any questions, please do not hesitate contacting Simon Lee at This email address is being protected from spambots. You need JavaScript enabled to view it..
On 18 & 19 November 2019, the European Medicines Agency convened stakeholders (including EUCROF, which was represented by its President, Dr Martine Dehlinger Kremer) for a workshop to discuss the outcome of the public consultation on the draft Regulatory Science Strategy to 2025, reflect on the prioritisation of core recommendations and identify concrete actions to implement the key goals and recommendations.
The draft strategy sets out working proposals on the key areas with which EMA intends to engage, in order to ensure that it has the regulatory tools to continue supporting the European Medicines Regulatory Network and fulfil its ongoing mission in light of upcoming scientific challenges.
The final strategy, expected in early 2020, will be a key contribution to the next EU Medicines Agencies Network Strategy (2020-2025) in addition to the Agency’s scientific committees’ and working parties’ workplans through to 2025.
One of the aims of the workshop was to identify concrete actions to implement the key goals and recommendations. The participants included patient representatives, healthcare professionals, academia, health technology assessment bodies, payers’ organisations, trade associations and regulators.
The event was by invitation only.
For more information 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. Also CLICK HERE for a direct link to the EMA paper.
EUCROF’s President, Dr Martine Dehlinger-Kremer, attended the Worldwide Duchenne Patient Academy Masterclass in Athens on 7th and 8th December 2019.
In this intensive two-day training session, both Next Generation Young Advocates and Experienced Advocates received a parallel training and updates to set a strong base for current and future global advocacy.
This Duchenne Masterclass focused on setting the foundation of advocacy and gaining a deeper understanding of the Duchenne field in terms of regulatory, HTA, clinical trial, care, research and industry developments.
Dr Martine Dehlinger-Kremer had the privilege to present on ”Clinical Trials 101 and the Role of the CRO” and ” Clinical Trials Readiness and the Role of Patient Organization”.
It was an amazing meeting with representatives from around the globe, all motivated to improve the situation of Patients with Duchenne. Congratulations to the World Duchenne Organization and its members for the great achievement.
For more information 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.
· The European Medicines Agency has published the “Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use”.
This guideline has been revised and provides new text to be included in the package leaflet of medicines containing ethanol as excipient. It contains more detailed information on the effects of ethanol when used as excipient, in particular on babies and children.
This document is the Annex to the European Commission Guideline on Excipients in the labelling and package leaflet of medicinal products for human use. It contains the information which should appear in the package leaflet for the excipients known to have a recognised action or effect. The annex is effective from 22 November 2019. For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the revised annex.
For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a type IB variation within 3 years after the publication of the revised annex.
Please find a link to additional information on the Annex. The rational for revising information on ethanol, which went through public consultation, has also been published: Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use.
- The EMA issued its latest edition of the monthly Newsletter in December 2019, which includes decisions by our Scientific Committees and updates on medicines safety. The EMA would welcome any feedback.
You can access the Newsletter by clicking here.
The EMA launched a number of consultations during the last 3 months and if you wish to participate and provide feedback please click the link(s) below as appropriate.
- The European Medicines Agency has released for public consultation the “Guideline on good pharmacovigilance practices (GVP) - Product- or Population-Specific Considerations III: Pregnant and breastfeeding women”.
For more details on the history of the GVP development process and latest updates, please click 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 28 February 2020.
As you will all be aware, next month EUCROF will be holding its 5th European Conference on 10 – 11 February 2020 in Amsterdam, The Netherlands.
Registrations are in progress and we have approximately 300 attendees already confirmed as attending. However, there are still spaces and, if you have not yet registered and are considering attending, CLICK HERE to register now to ensure you don’t miss out!
EUCROF is collaborating with both ACRON and BeCRO, the national associations of the Netherlands and Belgium to establish and run the Conference.
As with previous conferences, we are arranging an extensive programme of presentations, covering many key topics facing our industry today, all being presented by leading speakers on each topic. As with our previous conferences, we are sure participants will find the meeting and the content to be very beneficial and informative.
For further details please contact Darina Hrdličková at This email address is being protected from spambots. You need JavaScript enabled to view it. (Chair of the Organising Committee) and Michèle Garot, This email address is being protected from spambots. You need JavaScript enabled to view it. (Chair of the Programme Committee).
The first webinar for 2020 is scheduled to take place on 25 February from 10:00 AM to 11:30 AM (CET). It is entitled ‘The Patient Centricity Effect – How it benefits Patients, Sites and Sponsors – Practical Cases from Paediatric Studies’.
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 will be 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 will provide you with data and examples you can bring back to your own organization, 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 will complete the webinar.
Moreover, the webinar will provide 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 easy 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.
Presenters:
Rosamund Round, Vice President, Patient Innovation Center, Parexel International
Mariangela Lupo, Patients Advocacy Manager, TEDDY European Network of Excellence for Paediatric Clinical Research and Head of the Training and Advocacy Area, Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)
Registration deadline: 24 February 2020.
To Register CLICK HERE.
With the help and support of our Romanian colleagues of ACCSCR, we are organising our next General Assembly in Bucharest, scheduled on Thursday 4th June and Friday 5th June 2020.
It is also planned to hold our second General Assembly of the year in Tbilisi, Georgia with the support of our colleagues of SMO-Pharmina, on 3rd to 4th December 2020.
More information will be sent to all our member associations in due course. In the meantime, 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..
The focus of this meeting will be the ongoing development of the EU Clinical Trial Information System and will be attended by industry and academic stakeholders, as well as representatives from Member State regulatory authorities. EUCROF will be represented by Dr Martine Dehlinger-Kremer (President), Dagmar Chase (Chair Clinical Trial Legislation Working Group) and Simon Lee (Secretary). This is the first face to face meeting that is scheduled to take place in 2020. However, there is a webinar scheduled to take place earlier on 4 March with more meetings scheduled later in the year.
These meetings are to discuss this important topic ahead of the implementation of the European Clinical Trials Regulation in 2020. The focus is expected to be on what progress has been made on the software development, as the project moves toward the independent audit which is scheduled to start by the end of December 2020.
We will keep you all posted on future developments in this important area, but if you have any questions please don’t hesitate contacting Simon Lee at This email address is being protected from spambots. You need JavaScript enabled to view it. or 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 most recent General Assembly in December. Subsequently good progress is being made and the Platform is now under development with a targeted completion date of end of the first quarter 2020 with a launch shortly thereafter.
Christophe Golenvaux, chair of the Communications WG, is leading this initiative.
The entities able to use this platform will exclusively be EUCROF members, Associate members as well as Partners and companies having adhered to the EUCROF Code of Conduct for Data Protection.
The CRO Platform aims at:
- enabling anyone (public access) to make a search for potential CRO partners and therefore help leverage business collaborations;
- contributing to establish a higher visibility of EUCROF representativeness, by collecting data and statistics on its affiliates (e.g. effective number of affiliates, continuously updated information sets, effective number of employment positions etc.) and therefore help EUCROF efforts to become a highly recognised and acknowledged stakeholder with influential positions.
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.
