Dear Members, Associate Members, Partners and All,
Together with the EUCROF Board, I am very happy to present our third EUCROF Newsletter of 2019, reviewing activities since April 2019 and looking ahead at what is planned in the coming months. Since our last eNews, as you will see, the last months have been very rich in activities and initiatives.
Firstly, the Spring General Assembly held in Prague in June was a huge success and my sincere thanks to ACRO-CZ for hosting this excellent event. Once again, the event was well attended by our Members and we had a very good dialogue about many aspects important to EUCROF both now and in the future.
We have continued with our collaboration with the EMA attending a number of meetings in areas such as paediatric clinical research, Archiving and Decommissioning of computerised systems in clinical trials and continued our work on the EU Clinical Trial Information System, as it has entered its next phase of intensive development. My thanks to all those involved especially Ingeborg Boddeke who is acting as EUCROF’s Product Owner.
Also, good progress has been made with the initiation of activities toward our next International Conference to be held in Amsterdam in 2020 with registration now open. Therefore, please save the date and book your attendance as soon as possible. I am very pleased to announce that Fergus Sweeney, Head of Inspections and Human Medicines, Pharmacovigilance Division at the European Medicines Agency will be the Conference’s Key Note speaker as well as many other excellent speakers now confirmed.
EUCROF has continued to provide its training opportunities provided to Members and clients, through our webinars and the intense activities of our Working Groups, with key subject matter experts. We have now held 3 successful webinars this year with several others already scheduled so my thanks to all those involved, especially the members of the Events and Training Working Group for their professionalism and hard work in making these happen so effectively.
EUCROF continues to make positive steps with its plans to establish a Code of Conduct for the CRO sector relating to GDPR and we are having many positive discussions with interested industry stakeholders.
EUCROF’s influence is growing across many aspects of Clinical Research and thank you in advance for your continued contribution to our success.
I wish you a happy reading.
Martine Dehlinger-Kremer
EUCROF President
EUCROF held its Spring General Assembly in Prague on Monday 3rd and Tuesday 4th June 2019. Our sincere thanks to our Czech Republic colleagues of ACRO-CZ, for their excellent planning and hospitality during our stay and for the very enjoyable special social event on the Monday evening.
The meeting was a great success with 19 representatives from our Members Associations in attendance and 7 further joining by “Go to Meeting”.
Martine Dehlinger-Kremer, our President, welcomed Members attending the General Assembly and introduced the following agenda:
- Interim Progress Report 2019
- Financial Report 2018 (Vote for: 2018 Final Accounts & Discharge of Executive Board for the 2018 Report)
- Report Clinical Trial Legislation Working Group
- Associate Membership - in countries in which there is a local Association. Associate Members and Partners: Do we need to distinct?
- Update SOPs on Communication/Presentations and WG
- Meeting with ACRO-Cz & Introduction of EUCROF
- GDPR – Code of Conduct Update
- CT Regulation, CTIS, UAT
- Conference in Amsterdam
- Finance Policy
- Salary Survey
- ACRON suggestions on Bylaws
- Working Groups Update
- Brexit Survey Outcome
As you can see it was an extensive agenda with many important topics presented and discussed. For each of the agenda topics above there are slides available for reference and further detail plus also the minutes of the meeting, all of which are available in the restricted members’ area on the EUCROF website by clicking HERE.
For further information please contact the Secretary via email on 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. and/or our President on 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..
EUCROF continues to make positive steps with its plans to establish a Code of Conduct for the CRO sector relating to GDPR. Since the last update EUCROF has extended discussions to include other associations such as ACRO to capture the broader CRO sector and LEEM (French association of medicine enterprises) and EFPIA (European Pharma Association) for adoption by the pharma industry, which will be important to the Code’s future acceptance and success. Each of these meetings have been successful with each stakeholder having a task force focused on the GDPR area. Various presentations are planned in the coming months (with Medical Device representatives and the European biobanking research infrastructure, for instance) with the overall objective of achieving alignment and support for the initiative. Discussions with CNIL (French Data Protection Authority) continue to be positive and more face-to-face meetings are anticipated in the coming months.
The initiative is being led by Yoani Matsakis with support at meetings from Dr Martine Dehlinger-Kremer.
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.
In our last Newsletter we updated you all on the new approach to be taken by the EMA to progress the development of the Clinical Trials Information System (CTIS). This new approach involves an iterative and more agile project delivery model such that the project will develop and deliver functionalities through short-cycled sprints that require planning of the scope, analysis, design, development and delivery.
In the new delivery model, the former role of champion transforms into the role of Product Owner (PO). This implies more frequent and dynamic contribution from the business experts for clarification of the scope and for business validation of the functionalities that are developed.
Ingeborg Boddeke is acting as EUCROF’s PO with Lydia Dominguez as back-up PO and they continue to participate in the important testing activities with POs from other stakeholders’ associations.
The first PO meeting took place on 2-3 July 2019 with a further Webex meeting which was hold on 16 July to provide an update on progress to the broader stakeholder groups.
It is anticipated that there will be more to update you on in our next Newsletter as activities accelerate in the coming weeks and months, 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..
Representatives from Paediatric Networks, Research Infrastructures (RIs), European Reference Networks (ERNs), Charities, Patients’ Associations, Young Persons Advisory Groups (YPAGs), Companies’ Federations, Regulatory Agencies, Governments, Authorities had a very productive discussion during the Stakeholders Roundtable held in the framework of the 3rd General Assembly of the EPTRI (European Paediatric Translational Research Infrastructure) project, on March 27th, 2019, in Madrid at the Ministry of Health, Consumption and Social Welfare.
During the first part of the session, 17 stakeholders shared their views on how to underpin the huge paediatric research capacities in the EU in order to generate better results through collaboration. To this aim, they briefly presented their institutions and answered diverse questions regarding the utility of the survey launched by EPTRI (aimed to map research units with paediatric expertise and facilities at Pan-European level), their area of expertise within the different platforms of the project or whether they could contribute to the effective development of the RI. Dr Martine Dehlinger-Kremer was invited to present EUCROF as one of the EPTRI Stakeholders involved in the design of the future Research Infrastructure. She high-lighted the importance to develop and implement innovative methods for paediatric research, which may differ from the ones used in adult research, as they would need to be adapted to paediatric research. She also pointed out that "a Federation such as EUCROF would be in a position to promote the use of new innovative methods for better medicines for children."
A one-hour debate followed the presentations and was conducted by the EPTRI Coordinator, Donato Bonifazi.
The feedback of the participants is crucial to confirm the strategic relevance of the scientific domains identified by EPTRI through its thematic platforms and to define the strategy to design the new paediatric RI.
The summary report of the discussion is available here: https://bit.ly/2MXLGdg
For more information on the project visit the EPTRI website (www.eptri.eu) or contact Assia Rosati via email (This email address is being protected from spambots. You need JavaScript enabled to view it.) or Donato Bonifazi (EPTRI Coordinator) via email at This email address is being protected from spambots. You need JavaScript enabled to view it..
During the last few months the Events and Training Working Group has successfully progressed 2 more webinars to follow on from the highly successful webinar on GDPR held in April 2019. The webinars were as follows:
- On 28th May EUCROF’s second webinar of the year covered the topic “Understanding the Crisis around P-Values: Statistical Methods for the 21st Century”.
The presenter was Dr Bruno Boulanger, Chief Scientific Officer, PharmaLex, Belgium and Lecturer at the School of Pharmacy, Université de Liège (Belgium).
Webinar Overview
In literature there are more and more publications raising concerns about the interpretation and misuse of the p-values, in some cases to support decision-making. This is known as the “reproducibility crisis” and it is a primary concern for the biomedical research and pharmaceutical industry.
The purpose of the webinar is to explain the very meaning of the “reproducibility crisis” and the concerns surrounding the p-value and the hypothesis testing as expressed in the recent articles published by Nature and American Statistician, among other journals.
The ultimate objective is to provide a critical understanding of the ongoing crisis and anticipate changes.
- Does it impact the way all decisions are made within the pharmaceutical industry?
- Are some areas more impacted than others?
- Is it more a concern for early research or for clinical development?
- How are the regulatory authorities reacting to the concerns about p-value?
- What is likely going to happen in the next 10 years with that respect?
- Should you be concerned about this reproducibility crisis?
This informative session will help to evaluate risks and opportunities.
There will be a chance to introduce the value of Bayesian biostatistics and its concepts such as prior, posterior and predictive distributions, through a wide variety of examples covering all the range of activities. The differences with the usual (aka Frequentist) statistics will be explained. The opportunities shifting from the Frequentist to the Bayesian statistics will also be explained (for ex. the use of Bayesian statistics to develop a new treatment for rare or orphan diseases, the use of historical control, of innovative clinical trials. The use of Bayesian statistics for leverage Real World Data (RWD) will also be exemplified. We will show how this is also part of the new Clinical Innovative Design initiative launched by the FDA in March 2018.
In addition, it will be explained that the proper use of prior, posterior and predictive distributions for modelling is way more relevant for the type of reality, constraints and decision-making that is needed in the biopharmaceutical industry. Furthermore, we will demonstrate that it opens new opportunities for the development and quality of new products.
No equation will be used, and all concepts will be explained using real case studies in a graphical way, so that non-statisticians may easily approach the concepts and the added values for a riskless decision-making.
- The next webinar held was on 23rd July and covered the topic “Risk-based and Remote Monitoring”
The presenters were Goran Vesov, Quality Assurance and Training Director, OPTIMAPHARM and Ana Stojkovic, Country Manager, OPTIMAPHARM.
Webinar Overview
With the increasing complexity of the clinical trials, a need has surfaced for emphasising critical vs less important aspects of clinical trial management. Analysis for the efficacy of the traditional approach to monitoring of clinical trials demonstrated an unfavourable ratio between efforts and effect. ICH GCP E6 R2 defines innovative approaches, which include Quality Risk Management, Quality-By-Design, prioritised resourcing and risk-based monitoring. This webinar focused on risk-based monitoring as a principal measure for improving the quality and effect of the outcome of the clinical trials monitoring, whilst respecting resourcing needs. Other main topics included remote and centralized monitoring and their role in the risk-based approach.
Both webinars were highly successful and there are more to follow this year, so look out for the next webinar in ‘Forthcoming News’ in this Newsletter.
If you missed either of the above webinars and wish to access the presentation slides you can do by clicking HERE. There will be a fee of € 90 - for non-EUCROF members or € 60 - for EUCROF members (as per the original attendance fee).
To this aim, EUCROF has developed a Moodle e-learning platform in order to allow those who cannot participate in the webinar to attend it as well as to store all the webinar materials in a single platform that can be useful for the participants.
In the e-learning platform participants can find for each webinar, the pdf of the slide, the embedded recording, the short bio of the speaker and the abstract of the webinar.
Furthermore, a forum discussion has been foreseen, that is a virtual room on the e-learning platform that will be accessible at the end of the webinar and where attendees can publish some further questions they would like to address to the speakers or to start an open discussion on the topic of the webinar.
Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities (ICMRA) | European Medicines Agency. For more information Click the following …
EMA’s Human Medicines Highlights published its latest Newsletter in June 2019.
The bulletin includes decisions by the EMA’s Scientific Committees and updates on medicines safety. The EMA hopes that readers find it useful and welcome any feedback.
The newsletter, together with all its past editions can be found on the EMA website:
https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-june-2019_en.pdf
The EMA launched several consultations during the last 3 months and if you wish to participate and provide feedback please click the link(s) below as appropriate.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
The European Medicines Agency has released for public consultation an ICH guideline E8 (R1) on general considerations for clinical studies – Step b. Comments should be provided by 30th September 2019.
CLICK HERE for more information
The European Medicines Agency has published for public consultation two European Union herbal monographs on:
Please send your comments to This email address is being protected from spambots. You need JavaScript enabled to view it. by 15 September 2019 using the standard template.
Comments should be provided by 15 September 2019.
We are very pleased to announce a new member to the EUCROF family, namely Romania’s CRO Association, ACCSCR, which primarily represents CROs undertaking clinical trial activities in the country. This is another example of EUCROF expanding its geographical reach.
For more information please look at the association’s website https://www.accscr.ro/ and/or its President Mrs. Catalina Sarbu at This email address is being protected from spambots. You need JavaScript enabled to view it.
Following our first three highly successful webinars undertaken so far in 2019, we are pleased to announce our webinar, scheduled to take place on 11th September 2019 from 10.00 to 11.00 am CET.
It will be entitled “GDPR and CTR Interplay. One Year Later. Understandings and Questionings.” and will be presented by Thierry Lepoutre of Lambda Plus, Belgium.
Webinar Overview
A year ago, the GDPR came into effect. We were told about consent. We knew the consent. The two concepts seemed identical. It would be quite simple to reconcile the GDPR with the CTR.
Then we thought about implementing the GDPR and thought about its concepts. We therefore had to answer the first question in the implementation of the GDPR for clinical trials: what is the legal basis for the processing of personal data? And there, surprise… it was not that clear at all.
Consent is not the lawful basis for the processing of personal data in the processing of clinical trial data? Then we discovered that the consent is the lawful basis, the participating subject would be entitled to request to delete all collected data. This is contradicting the CTR which says that in case of consent withdrawal, collected data must be kept and processed and cannot be removed.
We therefore tried to think a little more and find solutions for the implementation of GDPR for clinical trials. We discovered new legal basis for processing of personal data and found that some of them would be of interest for clinical trials and allowed to reconcile GDPR and CTR.
Since then, the authorities have also helped us to interpret the two regulations.
In mid-January, the European Data Protection Board published a series of questions / answers to better understand the relationship between the two regulations.
At the end of March, the Council of Europe published a recommendation on the protection of health-related data. This session will provide detailed information on how to interpret GDPR according to CTR and other publications. We will finally cover the future of GDPR implementation for CROs with a Code of Conduct. Indeed, authorities encourage the setting up of code of conducts which would help ensuring interpretation and compliance with regulations in various data processing sectors.
A Code of Conduct would then also help data controllers in setting up confident relations with data processors adhering to the Code of Conduct. Once a Code of Conduct has received approval from the European authorities and once a processor adheres to it, the controller could have a certain level of confidence in the way the processor ensures compliance with regulation.
This session will then also cover the Code of Conduct that is currently being drafted by EUCROF for CROs.
As always, our webinars are great value and to join it will only cost 60 EUR for EUCROF Members and 90 EUR for non-EUCROF Members.
Set the date in your calendar and register to the webinar by CLICKING HERE
As you know from previous communications, EUCROF will be holding its 5th European Conference on February 1011, 2020 in Amsterdam. SAVE THE DATE and plan for your registration!! EUCROF is collaborating with both ACRON and BeCRO, the national associations of the Netherlands and Belgium to establish and run the conference. Registration is now open so don’t miss out on the opportunity to book early and save 150 Euros on the standard rate!!
- Early rate 620 Euros
- 380 Euros for one day.
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.
EUCROF is pleased to announce that Fergus Sweeney, Head of Inspections and Human Medicines, Pharmacovigilance Division at the European Medicines Agency will be the Conference’s Key Note speaker. Also, Douglas Peddicord, PhD, Executive Director of the Association of Clinical Research Organisations will be presenting on how the FDA supports Clinical Trial Innovation.
There will also be the opportunity to rent booth space and provide sponsorship to promote your company. For more information, CLICK HERE.
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 EUCROF Paediatric Working Group is pleased to present the first F2F training on “Essentials of Paediatric Clinical Research
- What you need to know when, preparing, conducting and monitoring paediatric clinical trials”.
The Training is going to take place in Madrid (Spain), on 24 October 2019, at C.N.I.O. (Centro Nacional de Investigaciones Oncológicas) C/ Melchor Fernández Almagro, Madrid.
It will provide an overview of the regulatory landscape for paediatric research, review specific and most important challenges with corresponding solutions in paediatric drug development.
Following the training, the participants will be familiar with the ethical and regulatory is-sues, specific protocol considerations, Informed Consent and Assent processes, drug formulations, safety specificities, recruitment, enrolment, and clinical monitoring specificities, as well as site interactions, relationships with paediatric research networks and infrastructures. Participants will be prepared to plan and execute paediatric clinical trials in any of the age groups which will result in obtaining higher quality data.
You can register on the EUCROF website https://www.eucrof.eu/webinars/trainings/24-october-2019-essentials-of-paediatric-clinical-research
You can take advantage of an early bird fee, when registering by August 31st.
We look forward to meeting you in Madrid!
EUCROF is pleased to have been invited to participate for the very first time to a global public stakeholder meeting on “ICH E8 (R1) - guideline on General Considerations for Clinical Trials".
The meetings will take place on 31st October 2019 in Silver Spring, MD, USA.
EUCROF will be represented by its President, Dr Martine Dehlinger-Kremer, Dr Dagmar Chase, Chair of EUCROF’s Clinical Trial Legislation Working Group and Dr Ulrike Lorch, WG Member.
Background: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has launched a public consultation concerning revision of the ICH E8 Guideline on General Considerations for Clinical Studies (E8(R1)). The draft revised Guideline is available for public comment until 30/09/2019 on the EMA website CLICK HERE.
As part of the consultation process, ICH will hold public meetings before the finalisation of the revised E8 Guideline. This will allow important concerns expressed by stakeholder groups, not represented in ICH, to be addressed and permit an essential modernisation of these foundational guidelines.
The final goal is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality.
The public consultation and meeting are part of a plan to update the ICH Guidelines related to clinical trial design, planning, management, and conduct, starting with the revision of the ICH E8 guideline and followed by the revision of the ICH E6 Guideline for Good Clinical Practice.
We continue to be invited to represent EUCROF at major events and meetings across Europe in the coming months.
On 11th September, Christophe Golenvaux, our Member representative on the EUCROF Executive Board will be representing EUCROF at the EFPIA Rentrée: "Connecting Healthcare" in Brussels, Belgium.
Also, in September (16th to 17th), EUCROF President, Dr Martine Dehlinger-Kremer will be participating in the DIA/EFGCP: Better Medicines for Children Conference in Amsterdam in the Netherlands, where she will give the conference introduction and session chair as well as being a member of the programme committee.
On 11th October our President, Dr Martine Dehlinger-Kremer will be participating in the Clinical Trials Symposium in Bucharest, being run by our news colleagues in Romania.
Finally, Dr Martine Dehlinger-Kremer, will attend a multi-stakeholder workshop entitled “EMA Regulatory Science to 2025” which will take place on 18th and 19th November 2019 at the EMA offices in Amsterdam.
If you are interested to find out more, please CLICK HERE.
