eNews June 2023

EUCROF held its Spring General Assembly Thursday 8 and Friday 9 June 2022 in Athens, Greece as guests of our Full Member HACRO. The meeting was a great success with 26 attendees in person and 15 virtual participants, representing 16 countries. 

Martine Dehlinger-Kremer, our President, welcomed all participants attending the General Assembly and introduced the following two-day agenda:

EUCROF Interim Progress Report (2023)

EUCROF Conference 2024 & 2026

CTIS Users Task Force

EU Benchmarking 2023

Working Group Updates (x10)

HACRO presentation

EUCROF 2023 (June to Dec 2023) - Objectives and Priorities

GDPR Code of Conduct

xShare Opportunity

Patients and Clinical Research – Duchenne Association

Talent Engagement Task Force

Clinical Research Barometer

Presentation by EUCROF Member Associations (Romanian Association – ACCSCR)

Cross Border Initiative (EU-X-CT)

Peer Review Committee

AOB & Closing Remarks

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 File Sharing Platform on EUCROF’s website.

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 addressed by the Task Force.  The final responses were submitted to the CNIL (French Data Protection Authority acting at the lead for this process) in the Autumn of 2022 and there have been subsequent calls and meetings with CNIL to resolve the final, mainly administrative points. After the first round of comments, which took place in November 2022, the 27 Data Protection Authorities were presented with the final draft of the Code for them to submit their last comments. The Legal Counsel of CNIL is now consolidating the review received from the DPAs. Therefore EUCROF Code of Conduct is very close to the final run of all the necessary approvals during the remainder of 2023. Once approved, this will represent the first transnational code in the sector and its launch will be a significant milestone for EUCROF.

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. Good progress is being made with CNIL, already providing feedback on the Quality Manuals for the Monitoring Board.

A Communication Strategy has been prepared and issued to EUCROF 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.

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

Hedda Magnusson (ASCRO – Sweden) is the internal lead for the Benchmarking Project, that was approved by the 2022 Spring General Assembly for the year 2023, and is being supported both by Benedikt van Nieuwenhove, who led the first project in 2021, as well as by a Ms. Shih-Chen Tong, a trainee located in Sweden.  

Progress is being made by the participating countries on this important initiative and more updates will follow in future newsletters.

It is fundamental for the success of the project to have Contact Points in all the countries represented in EUCROF.

In the first half of 2023, EUCROF representatives have continued to attend many meetings on behalf of EUCROF, ensuring our contribution is seen far and wide by our stakeholders across a number of topics. Since the last newsletter in April the following meetings have taken place:

• CTIS Forum Stakeholder Meeting on 25 April 2023, EMA Virtual meeting attended by Dagmar Chase
• UK Clinical Research - A Professional Awareness Update organised by CCRA on 28 April 2023 at the Royal Society for Medicine (London, UK), where Fiona Maini represented EUCROF with the presentation "Pivotal Advancements in Technological Innovation Across Clinical Trials"
• ISPOR 2023 (Conference for Health Economics and Outcomes Research) in Boston, MA - USA on 7 - 10 May 2023 –Martine Dehlinger-Kremer and Lamine Mahi proving a Poster Presentation on 09 May 2023: The Importance of Clinical Research Organizations (CRO) in Clinical Research and Impact of COVID-19 Pandemic (abstract ID 123661)
• Committee for Advanced Therapies (CAT) Stakeholder Meeting an EMA, Virtual meeting on 16 May attended by Dolores Pérez Méndez (Chair Innovative Medicine Working Group) presenting - Harmonization of the Authorization of Clinical Trials with Genetically Modified Organisms in the Context of CTIS and the New European Regulation.
• HACRO Meeting with Greek Ministry of Health on 8 June in Athens where Martine Dehlinger-Kremer presented on Paediatric Research and Yoani Matsakis on EUCROF GDPR CoC

Our thanks to all those who have represented EUCROF so far in 2023.

As you are aware, the EMA’s CTIS became mandatory achieved its go-live on 31 January 2022. Below is a selection of important information that has been recently issued by the EMA to help all stakeholders to effectively use the new CTIS.

• CTIS Newsflash – June 2023

With the aim to enhance communication with the CTIS user community, the EMA issues a regular CTIS newsflash providing key updates on CTIS and links to useful reference materials.

A status update highlighting the start of CTIS mandatory use is available on the CTIS website.

https://euclinicaltrials.eu/about-this-website/#status-update

Spotlight: Can a Sponsor Administrator create a CTA?

The Sponsor Administrator role has only permissions to manage users’ access (e.g. assign/amend/revoke roles or approve role requests). This role needs to be combined with the CT Admin role for the creation of initial CTAs or, for the creation of subsequent CTAs (e.g. SM, AMS and NSM), with the CT Admin or Application submitter role. More information is available in Module 7 of the CTIS online modular training programme on “Management of registered users and role matrix” and specifically in the Sponsors Business Processes and Roles (slides 8, 35-41) and role matrix for sponsors.

Clinical Trials Information System (CTIS): online training modules | European Medicines Agency (europa.eu)

Sponsors Business Processes and roles (europa.eu)

Sponsor workspace - Roles and permissions summary (europa.eu)

Key updates

• Dates for the Extended EudraVigilance medicinal product dictionary (XEVMPD) sponsor training courses in Q4 2023 are now available on the XEVMPD Training webpage.

Extended EudraVigilance medicinal product dictionary (XEVMPD) training | European Medicines Agency (europa.eu)

• The draft ICH E6 (R3) scientific guideline on good clinical practice has been published for open consultation. The guideline aims to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. Stakeholders are invited to submit their comments by 26 September 2023.

Open consultations | European Medicines Agency (europa.eu)

A fully virtual multi-stakeholder workshop on ICH E6 R3 public consultation is being organised by ACT EU Priority Action 4 (PA4) on 13 – 14 Jul 2023.

• Following the end of the public consultation period on the ICH M11 scientific guideline in the EU, an overview of comments received has been published. The purpose of this draft ICH guideline is to introduce a clinical protocol template and a technical specification to ensure that protocols are prepared in a consistent fashion and enable a harmonised data exchange format acceptable to the regulatory authorities. More information is available on the ICH website.

ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline | European Medicines Agency (europa.eu)

ICH Official web site: ICH

The latest issue of the CT Highlights newsletter is now available on the EMA website, including updates on milestones, upcoming activities, and new developments related to CTIS and the ACT EU initiative.

https://www.ema.europa.eu/en/news-events/publications/newsletters#clinical-trials-highlights-section

System improvements

The work continues in close collaboration with our stakeholders to deliver further system improvements and enhance the user experience.

More information on the latest system improvements is available in the published release notes as well as in the Lists of known issues and proposed workarounds.

https://euclinicaltrials.eu/website-outages-and-system-releases/

https://euclinicaltrials.eu/website-outages-and-system-releases/

More information

Are you a sponsor user starting out with CTIS? Please consult the ‘Sponsor quick guide: Getting started with CTIS’ or refer to the CTIS training material, including the new version of the ‘CTIS Handbook for clinical trial sponsors’. The handbook provides useful information on how sponsors can navigate CTIS to create and submit clinical trial information to the member states of the European Union as required by the Clinical Trial Regulation (EU) No 536/2014.

https://www.ema.europa.eu/en/documents/other/getting-started-ctis-sponsor-quick-guide_en.pdf

https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support#handbook-for-clinical-trial-sponsors-section

In January and February the CTL WG collected comments on the Draft Guideline ICH M11: Clinical Electronic Structured Harmonised Protocol (CESHARP). For the Phase 1 Community, it seems very difficult to work with a standard template when it comes to protocols, therefore the strongest reaction came from a Phase 1 Unit in favour of submitting comments.

The deadline for submission was February 26th which was met.  If you wish to obtain more information, please email EUCROF Secretariat on This email address is being protected from spambots. You need JavaScript enabled to view it..

Clinical Trials Logistics is a rapidly growing Clinical Trials Industry segment with a broad variety of new approaches in a very fast-changing environment. New technologies and techniques develop so fast, that industry and communication within industry sometimes simply have to just follow them.

To be industrially effective, CROCMOCDMO companies must have a wide range of enabling technologies and specialised handling capabilities to address specific problem statements. Although these services address many problem statements, there is a wide range of services or products design capabilities among especially CDMO players that can be critical in scaling a service or product concept and bringing it to the market.

All the above EUCROF could relay to Clinical Trials Industry within the newly created Clinical Trials Logistics Working Group where you are kindly invited to become a member!

 One of our goals is to communicate and respond to broad scope on Clinical Trials Logistics challenges!

The benefit to be a member of such a WG is certainly to have the international exchange of thoughts, solutions and very practical joint networking focused on industry issues solutions.

If you are interested in our joint activity, please contact:  This email address is being protected from spambots. You need JavaScript enabled to view it. and EUCROF Secretariat at This email address is being protected from spambots. You need JavaScript enabled to view it..

As you are aware, the EMA’s CTIS became mandatory achieved its go-live on 31 January 2022. Below is a selection of important information that has been recently issued by the EMA to help all stakeholders to effectively use the new CTIS.

• CTIS Newsflash – March 2023

With the aim to enhance communication with the CTIS user community, the EMA issues a regular CTIS newsflash providing key updates on CTIS and links to useful reference materials.

A status update highlighting the start of CTIS mandatory use is available on the CTIS website.

Launch date: Multi-factor authentication in CTIS

A multi-factor (MFA) authentication strategy for user logins to CTIS, for both Sponsor and Member State workspaces, will be launched on 1 June 2023. This strategy will effectively reinforce the security of user accounts. With MFA, users are asked to enter a second factor (besides username and password) when logging into an IT system to verify their identity. This second factor can be:

• A token received in Microsoft Authenticator mobile app, or
• An automated phone call or a text to mobile phone, or
• A call to office phone.

Users may choose their preferred second factor method and amend their choice at any time. In preparation for the introduction of MFA, it is recommended that each user is equipped with a mobile or an office phone that can be used for second factor authentication. Users can already log into the EMA ServiceNow portal to set up their MFA for EMA systems, which will work also for CTIS once deployed and activated.

The MFA for the Member State API will be rolled out at a later date and Member State users will be informed in advance.

Current operational experience with CTIS

With the aim to enhance transparency on system use, this section on weekly CTIS metrics provides key data and trends compared to the previous week. The data presented below refers to the period from 28 February to 6 March 2023.

Over 320 clinical trials authorised under the CTR are now available in CTIS.

EMA has initiated the process to register CTIS as a WHO data provider. Once the registration process is completed, CTIS data will be included in WHO’s International Clinical Trials Registry Platform (ICTRP) Search Portal. Further updates will be provided in the future.  

The latest issue of the CT Highlights newsletter is now available on the EMA website, including updates on milestones, upcoming activities, and new developments related to CTIS and the ACT EU initiative.

System improvements

The work continues in close collaboration with our stakeholders to deliver further system improvements and enhance the user experience.

More information on the latest system improvements is available in the published release notes as well as in the Lists of known issues and proposed workarounds.

More information

Are you a sponsor user starting out with CTIS? Please consult the ‘Sponsor quick guide: Getting started with CTIS’ or refer to the CTIS training material, including the new version of the ‘CTIS Handbook for clinical trial sponsors’. The handbook provides useful information on how sponsors can navigate CTIS to create and submit clinical trial information to the member states of the European Union as required by the Clinical Trial Regulation (EU) No 536/2014.

• • EMA communication: Human Medicines Highlights June 2023

  The EMA’s latest edition of the monthly Newsletter which includes decisions by its Scientific Committees and updates on medicines safety.

  For more details, please click here.

  Newsletters | European Medicines Agency (europa.eu)

  • EMA public consultation on the revision of the transparency rules of the Clinical TrialsInformation System (CTIS) - Deadline: 28 June 2023

  The European Medicines Agency has launched a public consultation on the revision of the transparency rules of the Clinical Trials Information System (CTIS), the IT platform supporting the implementation of the Clinical Trials Regulation (EU) No 536/2014 (CTR). This initiative is carried out under Accelerating Clinical Trials in the EU (ACT EU) Priority Action 2, which is focused on the successful implementation of the CTR.

  The consultation on the CTIS transparency rules intends to collect views from system users and stakeholders and stimulate discussions on the best possible approaches to balance transparency of clinical trials data in CTIS with confidentiality requirements, while also simplifying the modalities of use of the new system.

  In addition to the public consultation an interim guidance document and its annex have also been published Review of Transparency Rules for the EU Clinical Trials Information System (CTIS) | European Medicines Agency (europa.eu). The interim guidance document and the annex are intended for CTIS users and have been revised following the public consultation carried out in 2022.

  EUCROF’s Clinical Trial Legislation Work Group reviewed the transparency rules and submitted comments on behalf of EUCROF. If you require any information on this topic, please email the EUCROF Secretariat on This email address is being protected from spambots. You need JavaScript enabled to view it.

  • EMA communication: Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants

  International regulators have published a report highlighting the outcomes of their discussions on COVID-19 vaccines and the need for and strategy to update their composition, based on the emerging evidence on coronavirus SARS-CoV-2 variants and lessons learned from previous vaccine updates. The workshop, co-chaired by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), was organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) and took place on 8 May 2023.

  ICMRA COVID-19 Omicron variant workshop | International Coalition of Medicines Regulatory Authorities (ICMRA)

  Currently authorised vaccines continue to be effective at preventing hospitalisation, severe disease, and death due to COVID-19. However, protection against infection wanes over time and new SARS-CoV-2 variants emerge. Preliminary data show that COVID-19 vaccines adapted to the currently circulating strains improve immunity to recently emerged variants, such as XBB descendent lineages. 

  Meeting participants discussed the available scientific evidence on epidemiology, seroprevalence (i.e. the number of persons in a population who test positive for a specific disease based on blood serum measurements) and vaccine performance, and key regulatory considerations related to the adaptation of authorised or new COVID-19 vaccines against emerging coronavirus variants. There is a broad agreement that vaccine formulations for the upcoming winter season in the Northern hemisphere should include only one virus strain and be based on the XBB family of Omicron subvariants (such as XBB.1.5). International regulators also highlighted that such monovalent vaccines could be used for both booster and primary vaccinations (the latter, for example, only in young children below 4-5 years of age). They noted that only data on manufacturing and quality of the vaccine and laboratory data would be required for the authorisation or approval of strain changes for the already authorised COVID-19 vaccines, provided that post-authorisation data regarding vaccine quality, effectiveness, immunogenicity, and safety data are collected. 

  The meeting built on the experience and knowledge gained from a series of ICMRA workshops on COVID-19 vaccine development and virus variants held over the past three years. Participants included representatives of international regulators as well as experts from the World Health Organization (WHO).

  The workshop was co-chaired by Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at US FDA, and Marco Cavaleri, Head of Health Threats and Vaccines Strategy at EMA.

  This communication and related content are published here.

  Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants | European Medicines Agency (europa.eu)

  Please check EMA’s dedicated webpage on COVID-19 for the latest updates.

  Coronavirus disease (COVID-19) | European Medicines Agency (europa.eu)

  • EMA consultation: Draft ICH E6 (R3) guideline on good clinical practice – step 2b

  The European Medicines Agency has published for public consultation a “Draft ICH E6 (R3) guideline on good clinical practice – step 2b”.

  ICH E6 (R3) Guideline on good clinical practice (GCP)_Step 2b (europa.eu)

  The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.

  This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. This includes fostering a quality culture and proactively designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and engaging stakeholders, as appropriate, using a proportionate risk-based approach.

  Clinical trials vary widely in scale, complexity, and cost. Careful evaluation of the priorities involved in each trial and the risks associated with the priorities will help ensure efficiency by focusing on activities critical to achieving the trial objectives

  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 26 September 2023.

  template-submission-comments-ich-e6-r3-guideline_en.xlsx (live.com)

  • EMA communication: Use of real-world evidence in regulatory decision making – EMA publishes review of its studies

  Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources, including clinical trials. RWE can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties and national competent authorities. However, more effort is needed to better anticipate the need for such studies and to speed up their initiation to ensure that regulators have access to RWE in a timely manner.

  These are some of the findings of a report published today on the experience EMA has gained in conducting studies with real-world data (RWD) in the past year and a half. The report is part of the Agency’s efforts, alongside the European Medicines Regulatory Network (EMRN), to enable use of RWD in regulatory decision-making.

  In pharmacovigilance, it has become mainstay to use routinely collected data about a patient’s health status or the delivery of healthcare from a variety of sources other than traditional clinical trials to support decision-making. However, the use of RWE is less established in earlier stages of medicines development.

  Overseen by the EMA-HMA Big Data Steering Group, EMA and EMRN are working towards setting up a sustainable framework that enables the use and establishes the value of RWE in decision-making across the entire product lifecycle.

  Since the completion of an earlier pilot with the Pharmacovigilance Risk Assessment Committee (PRAC) in 2021, EMA has engaged in various pilots with its other scientific committees and working parties. The pilots aim to explore the need for, and usefulness of RWE generated by EMA to support regulatory decisions. While the pilots continue, the report takes stock of the experience gained so far with regulator led RWD studies. It focuses on studies conducted in addition to those performed in response to the COVID-19 public health emergency and the Pharmacovigilance impact strategy.

  The report covers the period from September 2021 until the first anniversary of the Data Analysis and Real-World Interrogation Network DARWIN EU® on 7 February 2023. During this period, 61 RWD research opportunities were identified, 30 studies initiated and 27 completed.

  The news announcement and the report has been published here.

  Use of real-world evidence in regulatory decision making – EMA publishes review of its studies | European Medicines Agency (europa.eu)

  • EMA consultation: Call for scientific data for use in HMPC assessment work on Maydis stigma

  The European Medicines Agency has published the following call for scientific data:

  • Call for scientific data for use in HMPC assessment work on Maydis stigma

  Scientific contributions should be sent by email to This email address is being protected from spambots. You need JavaScript enabled to view it. by 15 September 2023.

  Maydis stigma - call for scientific data (europa.eu)

  • EMA consultation: Concept Paper on the development of a guideline on the quality aspects of mRNA vaccines

  The European Medicines Agency has published for public consultation a concept Paper on the development of a Guideline on the quality aspects of mRNA vaccines.

  Concept paper on the development of a guideline on the quality aspects of mRNA vaccines (europa.eu)

  This concept paper addresses the need to establish a guideline on the quality aspects of mRNA vaccines. The number of clinical trial applications for human products and marketing authorisation applications for mRNA containing products significantly increased over the last few years and is expected to increase further in the future. Furthermore, a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. From an analytical and regulatory perspective, mRNA vaccines are interesting since their classification depends on the target and/or whether they are obtained chemically or biologically.

  Comments should be provided using this EU Survey form by 30 September 2023.

  EU Survey - Survey (europa.eu)

  • EMA consultation: ICH Reflection Paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data

  The European Medicines Agency has published for public consultation an ICH Reflection Paper on “Proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines”, co-authored by EMA, US FDA and Health Canada.

  ich-reflection-paper-proposed-international-harmonisation-real-world-evidence-terminology_en.pdf (europa.eu)

  This Reflection Paper builds on the 2022 statement from the International Coalition of Medicines Regulatory Authorities (ICMRA), offering a strategic approach for future ICH guidelines on the assessment of real-world data (RWD) and real-world evidence (RWE). It constitutes the first step towards international harmonisation of the following focus areas:

  • Convergence on terminology for RWD and RWE
  • Format for protocols and reports of study results based on RWD submitted to regulatory agencies throughout the lifecycle of medicines
  • Registration of study protocols and reports

  EMA is coordinating the public consultation in Europe in parallel with a consultation run by ICH, to ensure European stakeholders have the opportunity to comment.

  Your input is crucial to help shape the future ICH guidelines that will address the complexity of use and impact of RWD/RWE in medicines regulation.

  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 30 September 2023.

  submission-comments-ich-guidelines_en.xlsx (live.com)

  For more details on this topic, please click here.

  International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) | European Medicines Agency (europa.eu)