Dear Members, Associate Members, Partners and All,
Together with the EUCROF Board, I am very happy to present our second EUCROF Newsletter of 2019, reviewing activities in the period January to April 2019 and looking ahead at what is planned in the coming months of 2019.
Since the last eNews in January 2019, EUCROF and its members have been involved in numerous activities and initiatives. We have made good progress with our plans to develop a Code of Conduct relating to the General Data Protection Regulation (GDPR) with continued discussions with CNIL (French DPA) and other associations such as ACRO and the LEEM.
We have also been busy with our preparatory activities for our 5th International Conference on Clinical Research in Amsterdam. Although it is not until 10th &11th February 2020. My thanks to the members of both the Programme Committee and Organising Committee for their achievements, their commitment and efforts in the last few months which will continue for the rest of this year. I re-iterate my request to all EUCROF members to actively be involved in promoting this Conference given its importance and value to the industry. Any efforts you can make to highlight the Conference to your contacts would be greatly appreciated and will help it achieve the success we all desire.
Our support and involvement as a key stakeholder to the EMA continues with the next phase of the development of the Clinical Trial Information System. Testing is scheduled to start in June 2019 and will continue for some time beyond the end of 2019 and well into 2020. As you all appreciate this is a key pre-requisite to the implementation of the EU Clinical Trials Regulation which is so important for our industry.
I am pleased that we held our first webinar in April on GDPR. My thanks to the Events and Training Working Group for organising this highly successful event with over 50 attendees and also to the presenter, Khaled El Emam, for his excellent presentation . Further webinars have been scheduled for the upcoming months, so please keep visiting our website to stay updated.
Finally, our next General Assembly will soon take place in Prague on 3rd to 4th of June, which gives a great opportunity to all of our members to engage with the Executive Board and each other to help EUCROF achieve its goals during the rest of the year. I hope to see many of you there.
Wishing you continued success in 2019.
Martine Dehlinger-Kremer
EUCROF President
EUCROF is making excellent progress with its plans to establish a Code of Conduct for the CRO sector relating to GDPR. Discussions with CNIL (French Data Protection Authority) continue to be positive and more face-to-face meetings are anticipated in the coming months with the next one in May 2019 . In addition, EUCROF has extended discussions to include other associations such as ACRO to capture the broader CRO sector and LEEM and EFPIA for adoption by the pharma industry which will be important to the Code’s future acceptance and success.
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.
As you all are aware, EUCROF has been involved in supporting the User Acceptance Testing of the EU Clinical Trial Information System (previously called the Clinical Trials Database and Portal), which has been in development over the last few years. EUCROF has provided both off-site and, more recently, on-site testers from our Members.
Representatives from EUCROF attended a stakeholder meeting at the EMA in London on 20th February. At that meeting the EMA presented the next stages of development for this important project and informed of a change in the way stakeholders’ business experts will be invited to contribute to the development of the Clinical Trials Information System (CTIS).
The EMA believes it is important to ensure that stakeholders such as EUCROF participate in the definition, design and delivery of the system and emphasises on the importance that different sponsor types and expertise are represented. The EMA recognised that the contribution from sponsor champions to the development of CTIS has been significant and much appreciated over the years.
The EMA informed us that, at this time, the delivery of the Clinical Trials Information System (CTIS) has moved from UniSystems (Greece) to Everis (Spain) within the IT4U Consortium. Everis is since 2016 the Consortium lead and the supplier for the delivery of the safety reporting functionalities. This supplier is therefore well familiar with the system, the requirements and the working environment.
Furthermore, the EMA presented a move to a new, 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.
The EMA’s plan is for the project to switch to the new delivery model in June 2019 and preparatory work for the planning of the scope, clarification and prioritisation of the functionalities to be developed in the sprints will take place in March – June 2019.
In the new delivery model, the former role of champion transforms into the role of product owner. 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.
EUCROF is pleased to announce that our UAT Champion, Ingeborg Boddeke, and our Back-up Champion, Lydia Dominguez, will continue to participate in the important testing activities, as Product Owner and Back up PO respectively, along with Product Owners from other stakeholder associations starting in June 2019.
The team structure foreseen in the longer term for the iterative delivery model is to have one Sponsor Lead Product Owner and 4 Sponsor Product Owners. It is foreseen that the direct interaction by EMA and the IT supplier would be mainly with this team of 5 Sponsor Product Owners. This team will be supported by 4 additional Sponsor Product Owners to be regularly consulted and informed by their peers and to provide cover for the team of 5 in periods of absence. In addition to the direct interaction and the engagement of backups, Sponsor Product Owners are encouraged to share information and to consult other sponsor representatives, so that their input to the project represents that of the whole sponsor community.
We will keep you all posted on future developments in this important area, but 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.
Our Vice President, Dr Stefano Marini, represented EUCROF at this Workshop in Parma (Italy) on 26th March 2019 where he gave a presentation on the collaboration between CROs and Hospitals considering the new European Rules, i.e., the EU Clinical Trials Regulation.
For more information please contact Dr Stefano Marini via email on This email address is being protected from spambots. You need JavaScript enabled to view it. or Assia Rosati via email on This email address is being protected from spambots. You need JavaScript enabled to view it.
EUCROF had the pleasure and privilege to join the meeting that was organised in Madrid a two-day event on March 27th and 28th March 2019, at the Ministry of Health, Consumption and Social Welfare in the framework of the third EPTRI (European Paediatric Translational Research Infrastructure) General Assembly. Our President, Dr Martine Dehlinger-Kremer and Dr Donato Bonifazi, who is the EPTRI Coordinator, were both in attendance to give a presentation and participate in a stakeholder panel discussion.
EPTRI is an EU funded project coordinated by CVBF with the aim to enhance technology-driven paediatric drug discovery and development to be translated into clinical research and availability of medicines for children. This includes developing biomarkers, identifying molecules to test, genetics, developmental pharmacology and many other subjects.
The meeting in Madrid has foreseen a dedicated roundtable with the EU Stakeholders held in the afternoon session involving representatives from Paediatric Networks, Research Infrastructures, European Reference Networks, Charities, Patients’ Associations, YPAGs, Companies’ Federations, Regulatory Agencies, Governments and Authorities to promote the entrance of EPTRI in a global framework of partnership able to strengthen paediatric research.
The speaker’s extensive experience, interaction between participants, sharing diverging perspectives have made this GA a constructive and successful meeting for all involved.
Dr Martine Dehlinger-Kremer was invited to present EUCROF as one of the EPTRI Stakeholders involved in the design of the future Research Infrastructure and 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."
For more information 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.).
On 17th April 2019 EUCROF gave its first webinar of the year and we are pleased to say it was highly successful in terms of both content and number of attendees.
The webinar covered the highly important and topical area of GDPR and was entitled-
Doing More with Data: Data Anonymisation and Pseudonymisation under the GDPR.
The presenter was Khaled El Emam, Founder, General Manager, and President of Privacy Analytics.
Overview
Many organisations are trying to exploit more value from their data to improve their products and services, offer new ones and optimise their own internal operations. With the General Data Protection Regulation (GDPR) in place, these organisations need to determine the lawful basis for such activities. De-identification techniques, such as pseudonymisation and anonymisation, can play an important role in facilitating such secondary uses and disclosures of data. About de-identification, the GDPR introduces nuances that have not previously been seen, recognising the existence of different levels of de-identification and explicitly adding references to pseudonymisation as an intermediate form of de-identification. This webinar described pseudonymisation and anonymisation techniques, specifically for clinical trial data, and how these fit within the GDPR regulatory framework.
There will be a fee of € 90 - for EUCROF non-members or € 60 - for EUCROF members (as per the original attendance fee).
EMA SME Office published its latest Newsletter in March 2019.
The bulletin aims to highlight news, documents, and activities that may be of interest to SMEs and their stakeholders.
The newsletter, together with all its past editions can be found on the EMA website:
https://www.ema.europa.eu/en/news-events/publications/newsletters#sme-newsletters-section
If you have any questions or would like any further information on any of the topics contained therein, or any other EU regulatory issue, please do not hesitate to contact the SME Office (This email address is being protected from spambots. You need JavaScript enabled to view it.).
Also, in March the EMA published its latest edition of the monthly Newsletter which includes decisions by its Scientific Committees and updates on medicines safety. The EMA would welcome any feedback.
You can access the Newsletter by CLICKING HERE
MedTech Europe published the latest figures about the evolution of the medical technology market. To find out more click the link below…
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 the draft ICH guideline M10 on bioanalytical method validation – step 2b.
Comments should be provided by 1 September 2019.
CLICK HERE for more information
- The European Medicines Agency has released for public consultation the ICH guideline E19 on optimisation of safety data collection (step 2b).
Comments should be provided by 29 September 2019.
CLICK HERE for more information
With the help and support of our Czech Republic colleagues of ACRO-CZ, we are organising our next General Assembly in Prague, scheduled on Monday 3rd and Tuesday 4th June 2019.
Information has been already sent out to all Members, Associate Members and Partner Members. There is still time to register your attendance and if you can attend in person we look forward to seeing you in Prague for what should be a constructive and positive meeting.
Note that you can also join the meeting by GoToMeeting.
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 2nd Kiev Clinical Research Forum will be held this year on May 16-17 in Kiev (Ukraine). The Forum is organised by PharmaSich, a CRO in Eastern Europe headquartered in Kiev, Ukraine and is held under the patronage of the European CRO Federation (EUCROF).
Dr Martine Dehlinger-Kremer, President of EUCROF, along with Dr Sergii Myronenko from PharmaSich CRO, are part of the Organising Committee. Other EUCROF representatives in attendance will be Dr Stefano Marini, Donato Bonifazi, Jelena Vukotic, Yoani Matsakis and Michèle Garot.
The event aims to bring together international experts from industry, regulatory agencies, academia and non-profit boards to share views and knowledge on clinical research among all the participants, providing networking opportunities and adequate discussion between speakers and audience.
This second edition intends to follow the huge success of the inaugural Forum held in November 2017 and attended by 256 delegates form 19 countries.
Registrations are open!
ECRIN and its French scientific partner, the French Clinical Research Infrastructure Network (F-CRIN), are organising a conference in Paris, France on May 20th, 2019 to celebrate International Clinical Trials Day (ICTD).
ICTD 2019 will bring together ECRIN’s internal stakeholders and partners, and additional scientists and policymakers from France, the rest of Europe, and beyond. The meeting objective is to engage participants in discussion on issues related to multinational clinical trials and the clinical research landscape in Europe. ICTD 2019 will focus on challenges raised by patient stratification studies.
The meeting will take place at Luxembourg Palace, 15 rue de Vaugirard, 75006 Paris from 10:30 to 16:30 CET. Participation is free and on a first-come, first-served basis. Registration is mandatory.
After our first highly successful webinar of 2019 in April, we are pleased to announce our second webinar, scheduled to take place on 28th May 2019.
It will be entitled “Understanding the crisis around the p-values: Statistical methods for the 21st century” and will be presented by Bruno Boulanger, Chief Scientific Officer, PharmaLex in Belgium and lecturer, School of Pharmacy, Université de Liège, Belgium.
The webinar will 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 from 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 pharmaceutical industry?
- Are there some areas more impacting than others?
- Is it more a concern for early research or clinical development?
- How are the regulatory authorities reacting to those 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 the risks and opportunities.
This will be the opportunity to introduce the value of Bayesian biostatistics and its concepts such as 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, such as use of Bayesian statistics for developing new treatment for Rare or orphan disease, use of historical control, innovative clinical trials. The use of Bayesian statistics for leverage Real World Data (RWD) will also be exemplified. We’ll show how this is also part of the new Clinical Innovative Design initiative launched by the FDA in March 2018.
In addition, the fact that the proper use of priors, posteriors and predictive distributions for modelling are way more relevant for the type of reality, constraints and decision making that is needed in biopharmaceutical industry. We will also show 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 can understand the concepts and the added values for a riskless decision-making.
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 from February 10-11, 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.
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. 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).
We continue to be invited to represent EUCROF at major events and meetings across Europe in the coming months.
On 16th to 17th September 2019, 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.
In October (date to be conformed) EUCROF representatives will present at a conference in Algiers, Algeria - 1ères Journées Algériennes de la Recherche Clinique. In attendance with be Dr Martine Dehlinger-Kremer, Yoani Matsakis and Michèle Garot to support our Associate Member, Dr Salah Eddine Sahraoui of the Clinica Group.
