Dear Members, Associate Members, Partners and All,
Together with the EUCROF Board, I am very happy to present our fourth and last EUCROF Newsletter of 2019, reviewing activities since July 2019 and looking ahead at what is planned in the coming months. As you will see, EUCROF and its representatives have had an intense period since our last eNews, with involvement in many positive activities and initiatives.
The first topic I wish to highlight to you all is our next European Conference on Clinical Research to be held in Amsterdam on 10 and 11 February 2020. Registration is now open. As you will see, the programme, as always, is very strong, covering important hot topics and with excellent and well-recognised speakers from the authorities, pharma/ biotech, and patient representatives. We are looking forward to meeting you there.
In recent months, EUCROF has continued to make positive steps with its plans to establish a Code of Conduct for the CRO sector, relating to GDPR. We are having many positive discussions and gaining support from several interested industry stakeholders.
I have attended as a guest speaker at a number of conferences in Europe, supporting EUCROF members with their national activities, for example, in Romania and Greece, as well as attending meetings in Belgium, Spain and the Netherlands. My congratulations to all those who organised these very successful meetings.
I am so pleased to see that our webinars have continued to be a success with an average of 50 attendees participating to each one organised so far on important topics such as GDPR, risk-based monitoring, statistical methods and computer validation in the GCP environment. Thank you for your continued and increasing interest in these valuable training opportunities. I’m also proud to inform you that our first face to face training course on £Essential of Paediatric Clinical Research” was held in Madrid on Oct 24, registering more than 40 attendees and 12 very qualified speakers.
Also, I am pleased to inform you that EUCROF has further increased its geographical reach with the addition of an Associate Member, SM0-Pharmina from Georgia and D.O. Research based in Switzerland. I welcome you both to EUCROF!
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. Progress is being made with this challenging project and we all hope to receive further clarity on key milestones, such as the planned audit, following EMA management meetings later this year. My continued thanks to all those involved representing EUCROF on this project.
Finally, the General Assembly on 5th and 6th December will soon be upon us all and I, together with my fellow Executive Board Members, very much look forward to meeting many of you in Milan for 2 days of discussion and debate. My thanks to our Italian colleagues of AICRO for organising the event and making all of the arrangements.
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 and successful end to 2019!
Dr Martine Dehlinger-Kremer
EUCROF President
Our Events and Training Working Group has successfully progressed further webinars to follow on from the highly successful webinars held earlier in the year on GDPR (April 2019), Statistics Methods (May 2019) and Risk-based and Remote Monitoring (July 2019). The new webinars were as follows:
- On 11th September 2019, EUCROF’s 4th webinar of the year covered the topic “GDPR and CTR Interplay. One Year Later. Understandings and Questionings.”
The presenter was Thierry Lepoutre of Lambda Plus, Belgium.
Webinar overview:
A year ago, the GDPR came into effect and 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 2019, 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 2019, the Council of Europe published a recommendation on the protection of health-related data.
We will finally cover the future of GDPR implementation for CROs with a EUCROF 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.
- On 30th October 2019, EUCROF’s 5th webinar of the year covered the topic “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:
Nowadays, the collection, analysis and processing of data originated from a clinical study or for marketing settings is supported by specialised applications. Therefore, validation of computerised systems has become a central aspect in CRO’s daily work.
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.
For further 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 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..
EUCROF continues to make positive steps with its plans to establish a Code of Conduct for the CRO sector relating to GDPR with a number of important milestones achieved since the last Newsletter.
- During the summer period, HACRO has set-up a dedicated task force to further support the initiative on writing the Code. This is the 2nd EUCROF Member (after AFCROs) having a dedicated task force to support the initiative.
- Significant efforts are being made by our "local associations members" to support the initiative. A series of free of charge internal WEBINARS planned to present more extensively the initiative to all EUCROF Affiliates.
- EUCROF had formal exchanges with EFPIA (letters from its President) that resulted in a presentation made at the Global Data Protection WG of EFPIA on September 11th by Yoani Matsakis and with the support of Dr Martine Dehlinger-Kremer. EFPIA has decided to formally participate to the reviewing work of the Code and a more comprehensive cooperation scheme is currently being developed.
- EUCROF has participated to a 2-day workshop organised at the invitation of BBMRI where there was an exchange of experiences and purpose in relation to Codes of Conduct. This meeting took place in Brussels, October 1 and 2. Further cooperation with BBMRI in the field of Clinical Research is now envisaged.
- The review process of the Code is now close to start and should definitely be launched before the General Assembly in Milan with reviewers from EFPIA, LEEM, ACRO and CNIL.
- The European Data Protection Supervisor (EDPS), which is a full voting member of the EDPB has confirmed its participation to the session at our next Amsterdam conference on the subject of the EUCROF Code. EUCROF Code is now expected to be the 1st approved transnational Code in the domain of Health.
- The whole initiative shall be supported by the implementation of a EUCROF IT Platform that will offer new services to all EUCROF Affiliates.
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.
Our President, Dr Martine Dehlinger-Kremer, our Secretary, Simon Lee and the chair of EUCROF’s Clinical Trial Legislation Working Group, Dr Dagmar Chase attended a meeting at the EMA’s temporary offices in Amsterdam on 25th September 2019. This was a significant meeting in two ways; (i) the first meeting to be held following the EMA’s transfer from London to Amsterdam and (ii) the first face 2 face update of the progress of the Clinical Trials Information System (CTIS) following the switch to the new approach being taken by the EMA to progress this important project. 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.
Over recent months there has been significant interaction between the EMA, and those stakeholders involved. For EUCROF Ingeborg Boddeke acts as EUCROF’s Product Owner, with Lydia Dominguez Burgo as back-up PO, and they continue to participate in the important testing activities with POs from other stakeholders’ associations.
Although progress has been made, there continues to be uncertainty over exactly when the audit of the CTIS will take place and therefore when the system will be ready to be implemented. 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..
Since the last Newsletter in July 2019, our Clinical Trial Legislation (CTL) Working Group chaired by Dagmar Chase and the Pharmacovigilance WG co-chaired by Xavier Fournie reviewed the draft documents released for consultation by the EMA on ICH E19 (Optimisation of Safety Data Collection). The CTL WG and the Early Phase WG also reviewed the draft guidelines E8 (R1) (General considerations for Clinical Studies).
Both sets of comments were submitted ahead of the respective deadlines in September 2019 and our thanks to all those involved in contributing to our submission to the EMA. We will keep you posted on any feedback in due course.
For more information on the comments submitted 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.
Our President, Dr Martine Dehlinger-Kremer, had the pleasure of being the invited guest of Romania’s CRO Association, ACCSCR, at its Clinical Trials Symposium in Bucharest on 11 October 2019. (www.clinicaltrialsymposium.com). Dr Dehlinger-Kremer subsequently had the honour of attending the 1st Panhellenic Conference in Clinical Trials and Research, organized by the Association of Pharmaceuticals Products & Specialties (SAFEE)(https://www.pc-clinicaltrials.com/en)
At the meetings Dr Dehlinger-Kremer provided a general presentation on EUCROF activities as well as a more specific presentation on “Changes in the Paediatric Landscape” and “Essentials in Paediatric Research” respectively.
The symposia were a great success with hundreds attending each and who provided very positive feedback after event regarding the presentations, the open discussions and entire atmosphere.
Our congratulations to those members of ACCSCR, especially Christina Florescu, who led the organisation of the event in Bucharest and to those members of HACRO, especially Evangelia Koraki, who led the event in Athens. On behalf of EUCROF I would like to thank both associations for the opportunity to be present and support each of the events.
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 EUCROF Paediatric Working Group was 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 successfully took place in Madrid (Spain), on 24 October 2019, at C.N.I.O. (Centro Nacional de Investigaciones Oncológicas/National Center for Cancer Research), C/ Melchor Fernández Almagro.
There were over 40 attendees present for the training sessions and who heard 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 are familiar with the ethical and regulatory issues, 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.
Also, on 16th and 17th September, Dr Martine Dehlinger-Kremer participated in the DIA/EFGCP: Better Medicines for Children Conference in Amsterdam in the Netherlands, where she gave the conference introduction and session chair as well as being a member of the programme committee.
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 and/or take a look at the EUCROF website https://www.eucrof.eu/webinars/trainings/24-october-2019-essentials-of-paediatric-clinical-research
We are very pleased to announce new members to the EUCROF family, namely SMO-Pharmina, a CRO based in Georgia and D.O. Research, based in Switzerland. Both companies provide services to the Pharmaceutical companies and CROs in clinical trial management, including Site selection, Site management, monitoring, training. For more information please go to the respective company’s website www.smo-pharmina.net and doreserach.ch.
Dr June Raine to become interim Chief Executive Officer replacing the previous Chief Executive, Dr Ian Hudson, who steps down after 18 years with the Agency, six of them as Chief Executive Officer.
https://www.gov.uk/government/news/dr-june-raine-to-become-interim-chief-executive-officer
The EMA "Human Medicines Highlights" Newsletter - August 2019 issue. The newsletter, together with all its past editions can be found on the EMA website: You can access the Newsletter by clicking here.
Also, the EMA shared the Highlights of patient, consumer, healthcare professional and academia involvement in our activities in 2018 with the industry via the attached PDF document. The EMA gave its thanks to all for your continued support and participation in this year of change. EMA said that it is settling well into its new home in Amsterdam and getting back into full swing and was looking forward to further collaboration and new horizons with you all. For more information click here.
EUCROF was 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 took place on 31st October 2019 in Silver Spring, MD, USA.
EUCROF was represented by its President, Dr Martine Dehlinger-Kremer, Dr Dagmar Chase, Chair of EUCROF’s Clinical Trial Legislation Working Group.
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.
EUCROF will be holding its 5th European Conference on 10 – 11 February 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 until 30 November 2019!!
- Early rate 620 Euros
- 380 Euros for one day.
CLICK HERE TO REGISTER NOW!
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, Human Medicines, Pharmacovigilance and Committees Division at the European Medicines Agency will be the Conference’s Key Note speaker. Also, Douglas Peddicord, 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).
With the help and support of our Italian colleagues of AICRO, our next full end of year General Assembly will be in Milan on 5th & 6th December 2019.
You are cordially invited to attend the General Assembly and each association/partner is invited to send at least one and up to two representatives.
Information has been sent to all our member associations, so we hope you have this date in your calendar. We are looking forward to seeing you all in Milan!
In order to get the best rates on the selected hotel for the Conference, please confirm your booking as soon as possible, otherwise the discounted price cannot be guaranteed.
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..
EUCROF affiliates suggested the setup of a repository of individual CRO companies. These entities will exclusively be EUCROF members, Associate members as well as Partners and companies having adhered to the EUCROF Code of Conduct for Data Protection.
Christophe Golenvaux, chair of the Communications WG, is leading this initiative.
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.
We continue to be invited to represent EUCROF at major events and meetings across Europe in the coming months.
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.
Our Vice President, Dr Stefano Marini, will present at the Forensic Ozone Therapy meeting to be held in Rome, Italy on 30 November 2019. His presentation tile will be “Is Ozone to be considered as a Drug?”
