eNews January 2022

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Dear Members, Associate Members, Partners and All,


Together with the EUCROF Board, I am very happy to present our first EUCROF Newsletter of 2022, reviewing activities since October 2021 and looking ahead at what is planned in the coming months. Since our last Newsletter, the last months 2021 and start of 2022 have been very rich in activities and initiatives, despite the continued challenges we all face with the COVID-19 pandemic.

The first topic I wish to highlight to you all is our 6th European Conference on Clinical Research, a hybrid conference, which was held in Madrid and on-line on 7 and 8 February 2022.  The programme “Clinical Research in a New Era”, was very strong, covering important hot topics and with excellent and well-recognised speakers from the authorities, industry/ pharma/ biotech, Ethics Committees, Academia, and patient representatives. The Conference was converted to a hybrid arrangement due to COVID-19 restrictions, enabling participants to join virtually as well as in person, and this was well received by all participants. Your involvement and participation in this Conference was so important to its ultimate success, so my sincere thanks to all those who attended. In addition, my special thanks to my EUCROF colleagues who worked hard to organise the event and make it happen so smoothly, namely Darina Hrdličková (Chair of the Organising Committee), Benedikt Van Nieuwenhove (Chair of the Programme Committee) and Christophe Golenvaux (Chair of the Communications Committee), plus each member of these Committees. I also want to recognise the agency AIM for their professional support. Although it seems a long time away, our focus now turns to the next Conference taking place 26 and 27 February 2024. More news on that in future Newsletters.

It has been an exciting start to 2022 for the EMA and our industry as a whole with the ‘Go Live’ of the CTIS and EU Clinical Trial Regulation on 31 January.  At a recent stakeholders’ meeting, the EMA congratulated and gave its sincere thanks to all those involved in the CTIS project over the years. As you know, EUCROF and its representatives have played a significant part in helping the EMA develop the CTIS and will continue to support its future evolution. On behalf of the Executive Board, I would like to thank everyone who has contributed and represented EUCROF so amazingly over the last years of preparation.

Once again, we had a successful year for the Events & Training Working Group, both in terms of the actual number of webinars as well as the number of attendees. This led again to a positive financial outcome for EUCROF, which will be reinvested into many of our other initiatives and activities. My thanks again to all those who attended one or more of the webinars, to Donato Bonifazi (Chair of the Events & Training Working Group) and each members of this Working Group, for the professional manner they organise these webinars and, last but not least, to our speakers, for their fascinating and insightful presentations and the time they have dedicated to EUCROF. I am looking forward to more of the same this coming year.

I continue to be pleased by the progress being made with the establishment of the EUCROF Code of Conduct for the EU General Data Protection Regulation. The New Technologies Working Group Task Force continues to work with the relevant authorities and is taking the first steps in forming the required Monitoring Body ahead of its ultimate implementation in 2022.  My thanks to Yoani Matsakis and all the members of this task force. involved in progressing this important initiative. 

The Fall General Assembly in December 2021 was held remotely (due to COVID-19 travel restrictions), but nonetheless was a huge success. As with previous meetings, the event was well attended by our Members, Associate Members and Partners, and by EUCROF Affiliates. We had a very good dialogue about many aspects important to EUCROF with four Motions being voted on. It was excellent to see everyone involved and engaged on deciding how EUCROF will progress its activities in the coming year. So my thanks to all those who participated. At the meeting we were joined by our new Full Member ASCRO of Sweden and our new Associate Member PharmNDev, based in Switzerland. A warm EUCROF welcome to both!

Finally, I would like to personally thank everyone who has in some way contributed to the success of EUCROF during 2021. This enables us to achieve our goals and lays the foundations for even a greater success in the future. 

Good health and stay safe in the coming months!

                                                                                       

Dr Martine Dehlinger-Kremer

EUCROF President

EUCROF held its 6th European Conference on 7 & 8 February 2022 in Madrid, Spain, titled “Clinical Research in a New Era”. To establish and run this Conference, EUCROF collaborated with AECIC, the national association of Spain.

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, from industry, the authorities, and patient representatives as well as CROs.


We were pleased that this turned out to be a successful Conference so far with 258 registrations (of which 98 attending online) attendees, who, from the feedback we received, found the meeting and the content to be very beneficial and 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), Benedikt Van Nieuwenhove (Chair of the Programme Committee) and Christophe Golenvaux (Chair of the Communications Committee) plus each member of these Committees, without whom the conference would not have been a success.

The next Conference will be in 2024 and planning will commence very soon. Look out in future newsletters for updates.

The Fall GA took place on Thursday 2nd to Friday 3rd December 2021, as a virtual meeting due to the COVID-19 pandemic-related travel restrictions rather than in Munich, Germany. Although we were sad not to meet face to face in Munich, nevertheless, it was an excellent meeting with over 40 Members, Associate Members, Partners and Affiliated member CROs connecting.

Attendees represented 17 countries: Albania, Belgium, Czech Republic, Egypt, France, Germany, Israel, Italy, Slovakia, Spain, Sweden, Switzerland, The Netherlands, Turkey, Ukraine, United Kingdom, and USA.

Following a welcome from Dr Martine Dehlinger-Kremer, President of EUCROF, the agenda for the meeting was adopted. The meeting covered a wide range of topics including:

Summary of EUCROF Board Activities 2020/2021

Approval of 2020 accounts & Provisional Financial Situation 2021

EUCROF Achievements 2020/2021

EUCROF Conference in Madrid 2022 – Status Update

GDPR Code of Conduct

Working Groups update

  • Clinical Trial Centres
  • Clinical Trial Legislation
  • Communication
  • Events & Training
    • o Webinars
    • o Podcasts
    • o Access to previous Webinars and Podcasts
  • Medical Devices
  • New Technologies
    • o eConsent
    • o Archiving
    • o Artificial Intelligence
  • Paediatrics
  • Patients’ Associations
  • Real World Data & Digital Health
  • PharmacoVigilance 

Presentation of BVMA

Presentation of EUCROF

Presentation of SCRS

Votes for Motions

  • Approval of 2020 Accounts
  • Approval of 2022 Budget
  • Proposed budget 2022
  • Executive Board Mandate in the Bylaws

EUCROF 2021-2022 Objectives and Priorities

  • Proposal for the 2022 budget, including vote
  • Proposal for the EUCROF 2022 Budget

CRO Platform Update and CWG achievements

Location Proposal for GAs in 2022

Locations for Conference in 2024

Update on EMA’s Clinical Trial Information System

EU Benchmarking Outcome

Clinical Research Workforce Demand

Presentation of ASCRO (Swedish Association and new Full Member)

Presentation of PharmNDev (new Associate Member in Switzerland)

Final Closing Remarks

Of note was that at this GA there was an opportunity for Members to decide on 7 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 all of you who attended the meeting and to BVMA, which made so many arrangements before the switch to a virtual meeting. Thank you for your valuable contribution.


CTIS go-live successfully completed on 31 January 2022! At a recent stakeholder meeting the EMA Congratulations and sincere thanks to all those involved in the CTIS project over the years! The EMA said it was a huge achievement and ensures a bright future for clinical trials in the EU/EEA.  As you are probably aware from previous newsletters, EUCROF representatives have played a significant role in this development since the project started in 2014 when the Clinical Trials - Regulation EU No 536/2014 was first published and the EMA Management Board endorsed the Functional specification of the EU portal and EU database to be audited.

It has been an amazing achievement to date and EUCROF is pleased to have played a part in it.  Some important links for you to reference going forward, associated with the public website & secure domains.

As expected, there are a number of key activities post go-live which the EMA team, with the support of stakeholders, will progress

  • 6 months Hyper-care and stabilisation (incident management and technical deliveries)
  • Facilitate the harmonised query management process
  • Provide CTIS training and keep training material up to date
  • Revision and finalisation of Guidelines and Procedures related to CTIS processes
  • Analyse feedback and priorities for further CTIS functionality development

EUCROF representatives will remain part of the team to help deliver the above in the coming months and years. Our special thanks to our two Product Owners, Vicki Iassonidou and Lydia Domingues, and our training expert Marieke Meulemans for all their effort and commitment over the years and their continued support in the future.

Remember

https://www.ema.europa.eu/en/news-events/publications/newsletters#clinical-trials-information-system-(ctis)-highlights-section

Please remember to find the online training modules here:Clinical Trials Information System (CTIS): online modular training programme | European Medicines Agency (europa.eu). If you have any questions, please contact the EUCROF Secretariat (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’s New Technologies Working Group has been developing the GDPR Code of Conduct for several years. In recent times, it has achieved a number of important milestones. As part of the Cooperation Phase the review of the Code by the various Data Protection authorities across Europe has progressed well with comments now received. These comments are currently being addressed by the Task Force.  

In parallel, EUCROF is making steps to establish the Monitoring Board to provide the independent oversight of the Code once it is implemented and is in discussion with a number of stakeholders with a view to gaining their contribution and involvement.

A Communication Strategy has been prepared and issued to EUCROF’s members. Going forward, it will be important for the success of the Code to ensure there is awareness and understanding of the benefits of the Code among all stakeholders of clinical trials.

Several presentations of the Code of Conduct are scheduled for the coming months to members to increase awareness and understanding ahead of launch. The CRO Platform is being updated and at the end of October the companies wishing to adhere to the Code may start the adherence process.

Consult the EUCROF website for future updates on this important initiative.

The webinar programme organised by EUCROF’s Events & Training Working Group continued to be highly successful in 2021 with 7 webinars, 2 podcasts and finally a training day.

  • EMA Clinical Trials Information System (CTIS) – ​​Be ready before go live​​
  • Staying safe on the way to innovative therapeutic options – ​​Phase 1 trials in research clinics
  • Implementation of the General Data Protection Regulation (EU) 2016/679​​
  • eConsent Implementation Guide
  • The home care services - useful tool for decentralized clinical trials
  • Future of clinical trials: Navigating complexities to increase investigator satisfaction
  • Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials

The 2 podcasts were on eConsent https://www.eucrof.eu/news-eucrof/latest-news/03-09-eucrof-podcast-n-3-econsent  and EU CTR and CTIS readiness  https://www.eucrof.eu/news-eucrof/latest-news/19-11-eucrof-podcast-4-eu-ctr-and-ctis-ready-or-not-here-it-comes] making it 4 in the series to date.

The training day was entitled Personalised Medicine – Current applications in clinical practice and regulatory framework” – virtual training on 2nd November 2021 from 10:00 to 15:30 and had 24 participants!

Training Objectives:

  • - Provide an overview of Personalised Medicine and its current applications in clinical research.
  • - Explain personalised medicine principles, the development and use of biomarkers and the impact of pharmacogenomics illustrated by a series of case studies.
  • - Allow participants to be more familiar with clinical trial design, the EU regulatory framework and the ethical challenges in the era of personalised medicine. 

Note, the recording of each of the above webinars is available in the eLearnIN Platform (https://elearnin.cvbf.net/) if you wish to listen to any of them. For more information please visit the dedicated webpage (https://www.eucrof.eu/webinars) and contact the EUCROF Secretariat (Assia Rosati) via This email address is being protected from spambots. You need JavaScript enabled to view it..

Despite the ongoing challenges presented by the COVID-19 pandemic, 2021 was a remarkably busy year with colleagues representing EUCROF at multiple meetings across a number of topics.  In the last few months of 2021 EUCROF represented at the following meetings: -

  • 1st International Conference on Rare Diseases and Paediatric Research, 95, Rare Alliance Greece, CVBF, Athena Research and innovation centre on 18-19 November 2021 virtually attended by Dr Martine Dehlinger-Kremer, Member of Programme Committee & Presentation on "Clinical Trial Readiness: The patients’ contribution"
  • Clinical Trials Symposium 2021, Romania, 19 November 2021 attended by Dr Martine Dehlinger-Kremer providing the Opening Remarks of the conference, Presentation and Panellist for "Deep dive into decentralised clinical trials"
  • Duchenne Patient Academy 2021 virtual meeting took place on 4 December 2021 Dr Martine Dehlinger-Kremer presented on “The role of CROs in returning individual clinical trial data back to participants”
  • Gianni Benzi Foundation, XIV Foresight Training Course: The health emergency: regulatory crash and future perspectives –Virtual Meeting on 10 December 2021 attended by Dr Martine Dehlinger-Kremer presenting "Clinical research after the COVID-19 era: the current scenario and the upcoming application of the Clinical Trials Regulation"

In total EUCROF participated in 29 events during the year, including 8 International Conferences,

16 Meetings with the EMA and 5 Meetings with the EU Commission. Our thanks to all those who have represented EUCROF throughout 2021. It is anticipated that 2022 will be even busier so look out in Forthcoming Events in this and future newsletter for information on these events throughout the year.

  • Guideline on registry-based studies published 

EMA has published a guidance to provide key methods and good regulatory practices to pharmaceutical organisations on the planning and conduct of registry-based studies.

This guideline aims to help those involved in registry-based studies to better define study populations and design study protocols; it provides further guidance on data collection, data quality management and data analysis to achieve higher quality evidence. This in turn will facilitate EU regulators’ assessment of the safety and effectiveness of medicines, for the benefit of public health.

As patient registries are key to conducting registry-based studies, the guidance includes an annex with good practices in the establishment and management of patient registries and their use for other regulatory purposes.

This guideline will facilitate a more data-driven, robust regulation of medicines, as foreseen in the Big Data Steering Group Workplan that implements the Network Strategy to 2025. It is based on a discussion paper on methodological and operational aspects for use in patient registries for regulatory purposes, which was available for public consultation and generated almost 1,000 comments from 68 stakeholder organisations. Experience gained from EMA’s human medicines committee (CHMP) qualification opinions for two networks of registries, and input collected during five workshops on specific patient registries organised by the Agency also fed into the final guidance.

This communication and related content are published here.



  • EMA Publication of the article: "Informed consent and assent guide for paediatric clinical trials in Europe"

EMA is pleased to announce the publication of the article “Informed consent and assent guide for paediatric clinical trials in Europe” in Archives of Disease in Childhood and to herein provide you with the link to the publication which will be available soon on the Enpr-EMA web page. Dr Martine Dehlinger-Kremer, the President of EUCROF was one of the authors of this document. :

Article: Informed consent and assent guide for paediatric clinical trials in Europe
Free to access link: http://adc.bmj.com/cgi/rapidpdf/archdischild-2021-322798?ijkey=5le62Zy2d0srj66&keytype=ref


  • EMA communication: "Human Medicines Highlights" Newsletter – January 2022 issue 

Latest edition of the monthly Newsletter which includes decisions by the EMA Scientific Committees and updates on medicines safety. We hope that you will find this useful and welcome any feedback.

You can access the Newsletter by clicking here. Previous editions can also be found on this page.

https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-january-2022_en.pdf


  • CTIS Change Management team Video Recording Published - October Virtual Info Day

The CTIS Change Management team are pleased to share that a video recording of the virtual event 'Clinical Trials Information System (CTIS): The future user perspective', held on 26 October, is now available at EMA’s corporate website: Clinical Trials Information System (CTIS): Virtual information day | European Medicines Agency (europa.eu).The purpose of this Information Day was to help future CTIS users prepare for submitting and evaluating clinical-trial applications in the system after its go-live on 31 January 2022. The virtual event, aimed mainly at clinical-trial sponsors and contract research organisations, was organised with support from the DIA and registered a high attendance. Please feel free to share this announcement within your network.


  • EMA SME Newsletter: Issue 54

Please find attached the latest issue of the Newsletter published by the EMA SME Office.

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/human-regulatory/overview/support-smes#newsletterssection

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.).


  • Press release and press briefing on CTR/CTIS go-live

On 25 January 2022, the European Medicines Agency (EMA), European Commission (EC) and Heads of Medicines Agencies (HMA) published a press release and held a joint press briefing to provide an update on the application of the Clinical Trial Regulation, and the go-live of the Clinical Trials Information System (CTIS) on 31st January 2022.

The URL for the Clinical Trials public website, which includes the login link for the sponsor and authority workspaces, will be made available on 31st January, via the EMA website and social media channels.

To read the press release please click here. In addition, a video recording of the live-broadcasted event can be found here. 

Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched | European Medicines Agency (europa.eu)

https://www.ema.europa.eu/en/news/regulatory-harmonisation-clinical-trials-eu-clinical-trials-regulation-enter-application-new


  • Joint press release on Accelerating Clinical Trials in the EU (ACT EU)

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) are coming together to optimise the environment for clinical research in Europe by launching Accelerating Clinical Trials in the EU (ACT EU).

This initiative will use the momentum of the incoming Clinical Trials Regulation on 31st January to further promote the development of high-quality, safe and effective medicines.

One of the initiative’s priority actions will be to establish a multistakeholder platform, where all voices, including those of patients, can contribute to enabling better clinical research.

To find out more please click here for the joint press release on ACT EU

Accelerating Clinical Trials in the EU (ACT EU): for better clinical trials that address patients’ needs | European Medicines Agency (europa.eu)


  • EMA public consultation: Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics 

The European Medicines Agency has published for public consultation a

Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics.

This guidance is intended to provide the relevant parties, in particular notified bodies, device manufacturers and medicinal product applicants, with information about procedural aspects of the consultation procedure to the European Medicines Agency by a notified body on a companion diagnostic.

It gives practical guidance on what should be considered for: 

  • The initial consultation procedure to the European Medicines Agency by notified bodies on a companion diagnostic medical device.
  • A follow-up consultation in case of changes affecting the performance and/or the intended use and/or the suitability of the device in relation to the medicinal product(s) concerned for which the notified body considers there is a need for a supplement to the EU technical documentation assessment certificate and hence a further consultation with the European Medicines Agency.

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 20 February 2022.


  • EMA consultation: Guideline on the acceptability of names for human medicinal products processed through the centralised procedure​ 

The European Medicines Agency has published for public consultation the

guideline on the acceptability of names for human medicinal products processed through the centralised procedure.

This 7th update of the guideline further clarifies specific aspects of the criteria applied to address safety and public health concerns, international non-proprietary names issues and product-specific concerns in proposed (invented) names. This update also provides further information on the conditional acceptability of invented names and the process for bilateral negotiations and proposes changes to the duration of the validity of an (invented) name and the review process of the NRG.

The updated guideline is open for comments until 16 March 2022. Comments should be sent to This email address is being protected from spambots. You need JavaScript enabled to view it. using the form for submission of comments.

The 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 and targeted consultations.

The Spring GA will take place on Thursday 9th to Friday 10th June 2022, face to face in Prague, where we will be the guests of our Full Member in the Czech Republic. As always, this will be an important meeting to evaluate the status of current initiatives and agree on future initiatives for 2022 and beyond for EUCROF.


More information will be sent to all our Member Associations in the coming weeks, but in the meantime, if you have any questions, please contact the EUCROF Secretariat (Assia Rosati) via email on This email address is being protected from spambots. You need JavaScript enabled to view it..

The Events & Training Working Group is finalising another exciting programme of webinars and Podcasts for 2022.

  • It is planned that 8 webinars will be organized and delivered through GoToWebinar and the Moodle eLearnIN platform. The first webinar on EU CTR and CTIS will be prepared in the first quarter 2022. Topics for other webinars will be released in due course.
  • A one-day face to face training course covering advancements in clinical research, hot topics, or specific fields of interest, will be organised. This course will improve clinical research skills of participants through a series of presentations delivered by high-level experts in the field. It will enable participants to apply relevant knowledge and skills gained from the course to their working environment, i.e. development of effective strategies and problem solving for managing clinical trials, etc.
  • After 4 successful podcasts launched on the EUCROF website on 2020 and 2021, two more podcasts will be prepared on topics relevant to clinical research or to get more in-depth knowledge on issues or questions raised during previous EUCROF webinars and training courses. These episodic series will be saved on the news section of the EUCROF website (alerts and advertisement will be provided through the EUCROF LinkedIn channel) as individual media that users can download in order to listen at any time.

Keep consulting our website for updates (https://www.eucrof.eu/webinars). Further details will be issued in the coming weeks, so look out for the email from This email address is being protected from spambots. You need JavaScript enabled to view it..

In 2022 we expect to continue to be invited to represent EUCROF at major events and meetings across Europe. So far, the following have been confirmed.

  • CTIS Expert Group and Stakeholders Meeting (virtual) on 3 February 2022, where Dr Dehlinger-Kremer, Simon Lee and Dagmar Chase will represent EUCROF in what will probably be the last CTIS Meeting
  • The EUCROF President, Dr Martine Dehlinger-Kremer, has been invited to ACRO’s 20th anniversary celebration, which will be held in Washington DC on 16 March 2022.
  • Presentation of the GDPR CoC to the BPI-KliFo-Committee on 21 March 2022 – a virtual meeting where Yoani Matsakis, EUCROF’s Treasurer and Working Group Co Chair will be giving an update on the benefits and plans for the EUCROF Code of Conduct for GDPR.
  • National Conference for Clinical Trials in Algiers (Algeria) on 26-27 March 2022 where     Dr Martine Dehlinger-Kremer and Yoani Matsakis will be EUCROF invited guests, the former presenting about "International regulations: impactful news from the last 3 years"
  • Face to Face Paediatric Training - “Essentials of Paediatric Clinical Research: What you need to know when preparing, conducting and monitoring paediatric clinical trials”. This meeting will involve Authorities, PDCO members, Industry, Members of EUCROF’s Paediatric Working Group.

SCRS European Site Solutions Summit on 13 - 15 November 2022 in Lisbon, Portugal. EUCROF’s President Dr Martine Dehlinger-Kremer will be providing a presentation in the plenary session. Title to be determined.