eNews March 2023

The Conference Task Force and the agency to support the Conference were selected at the end of last year so that activities could commence at the start of 2023.

The Agency is Delegant, based in the UK, and the Task Force is chaired by Simon Lee, EUCROF’s Board Secretary, and currently has the following members: -

Martine Dehlinger-Kremer – EUCROF President and member of the Programme Committee

Dagmar Chase – Co-Chair of the Programme Committee

Benedikt Van Nieuwenhove - Co-Chair of the Programme Committee

Darina Hrdlickova – Chair of the Organisation Committee

Yvonne Rollinger – member of Programme Committee

Donato Bonifazi – Chair and representative of the Events and Training Working Group

If you wish to contribute to either the organisational aspects or programme development, please contact the EUCROF Secretariat (This email address is being protected from spambots. You need JavaScript enabled to view it.).

 The venue and date have been confirmed as 19 & 20 February 2024 at the Marriott Hotel in central Prague (Czech Republic).

Social media activities have started and are gathering momentum via LinkedIn, including a Call for Abstracts, and various announcements which will continue throughout the coming year. 

So please SAVE the DATE and let your colleagues and network know about the conference. All of EUCROF’s members and affiliates have an important part to play in its ultimate success.

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 2002 and there have been subsequent calls 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.

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.

We are very pleased to inform you that Hedda Magnusson (ASCRO – Sweden) is the internal lead for the Benchmarking Project, that has been approved by the 2022 Spring General Assembly for the year 2023.

The lead will be supported both by Benedikt van Nieuwenhove, who led the first project in 2021, as well as by a trainee, currently being recruited.  

In order to support the Benchmarking project EUCROF is planning to develop, we invite Members who have not done so far to identify a Contact Point person + a backup and convey their details (mobile phone + email address) to the EUCROF Secretariat (This email address is being protected from spambots. You need JavaScript enabled to view it.).

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

The recently established 3Rs working party (3RsWP) will take over the activities of the former Joint CVMP/CHMP Working Group on the Application of the 3Rs in Regulatory Testing of Medicinal Products (J3RsWG). The 3RsWP is composed of 6 European experts nominated by CHMP and CVMP members. It advises EMA Committees on all matters concerning the use of animals in the regulatory testing of medicines, with particular focus on the application of the so-called 3Rs principles - replace, reduce, and refine.

The annual stakeholders meeting with the newly formed 3RsWP was held on the 28th of February 2023 and EUCROF was represented by Jana Brajdih Čendak (Slovenia) with the presentation “Adverse Outcome Pathways (AOPs) - Tool for developing and assessing non-animal data”. We thank Jana for her great contribution.

The final months of 2022 and first few months 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. In the last few months EUCROF has been represented at the following meetings: -

• 2nd Bi-annual Big Data Steering Group and industry stakeholders meeting on 3 November attended by Lyle Wiemerslage (Viedoc - ASCRO) - EMA (virtual meeting)
• SCRS European Site Solutions Summit on 13 - 15 November 2022 in Lisbon, Portugal. EUCROF’s President, Dr Martine Dehlinger-Kremer, provided a presentation on “Inclusion of Adolescents into Adult Trials” in the plenary session and co-chaired the panel discussion on Paediatrics.
• Annual Clinical Trials Symposium on 18 November 2022 in Bucharest, Romania attended by Martine Dehlinger-Kremer – presenting on Introduction of the Symposium (Reshaping the Clinical Research Landscape)
• EFGCP/EFPIA - Cross Border Clinical Trials Initiative, KOM, an EFPIA, Virtual event on 24 November 2022 attended Helena Luning and Darina Hrdlickova
• Duchenne Patient Academy – a virtual conference on 2 December 2022 attended by Dr Martine Dehlinger-Kremer as speaker and panellist.
• EMA Risk Management Virtual Information Day on 9 December 2022 – an EMA virtual meeting attended by Marco Anelli (Chair of PV WG).

With the above meetings this meant that EUCROF attended 26 meetings in 2022, which is an excellent outcome for the year. Thank you to all those who represented EUCROF last year!

Moving onto 2023, it has already started to be busy with several meetings attended.

• ACRP Workforce Development Global Roundtable on 12 January 2023 – a hybrid meeting based in Herndon, VA - USA attended by Martine Dehlinger-Kremer, Sárka Blažková and Sue Fitzpatrick
• Brocher Foundation Paediatric Conference on 24 - 25 January 2023 in Hermance (Switzerland) attended by Martine Dehlinger-Kremer as Co-chair with Lynne Yao (FDA) of session "Newer Study Designs and Other Methods of Generating Data"
•  3Rs Working Party Annual Stakeholders Meeting on 28 February 2023, attended by Jana Brajdih Čendak, presenting “Adverse Outcome Pathways (AOPs) - Tool for developing and assessing non-animal data”

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

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 of 2022

In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 41 had a new active substance which had never been authorised in the European Union (EU) before. The overview of the 2022 key recommendations published today includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.

Public health emergencies remained a key priority for EMA in 2022. The highlights document summarises the most important recommendations on vaccines and treatments for COVID-19 and for mpox (monkeypox).

Once a medicine is authorised by the European Commission and prescribed to patients, EMA and the EU Member States continuously monitor its quality and benefit-risk balance and take regulatory action when needed. Measures can include a change to the product information, the suspension or withdrawal of a medicine, or a recall of a limited number of batches. An overview of some of the most notable safety-related recommendations is also included in the document.

For more details, please click here.

• Latest News on the EU-X-CT Multi-stakeholder Initiative

EUCROF is participating in the EU Cross-border Trials initiative, EU-X-CT, represented by Darina Hrdlickova (ACRO-CZ) and Helena Lüning (ASCRO). As soon as you have a moment, have a look at the info posted on our Latest News section on the EUCROF website (Latest News (eucrof.eu)).

Short background: There is no EU legal framework that defines the conditions to access clinical trials in another EU country. To support patients, investigators, and sponsors in enabling cross-border access to clinical trials, EFGCP and EFPIA has launched this initiative and representatives from patient organizations, industry, academia, CRO and medical society will work together with the objective of “Borders are no longer Barriers” to make cross-border access a reality for patients.

The initiative will run over 2 years and will be presenting final recommendations in 2025.

Currently we are working under 3 Task Forces

• Legal/regulatory aspects
• Financial aspects
• People/operational aspects

Message from Helena: I am participating in TF 1 (Legal/regulatory aspects) and we have had our first meeting. We are aiming to have a survey out to a limited group of experts in this field, legal/regulatory, in mid-March. I am now taking the advantage of EUCROF and asking for any feedback from your respective countries.

Please provide any contact information of organizations and people in your subsidiaries and networks in your country (name, contact details). At this time point the authorities are not involved.

If you have any questions, please reach out. Thank you for supporting this important initiative.

• EMA communication: PRAC starts safety review of pseudoephedrine-containing medicines

EMA’s Safety Committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain. Pseudoephedrine is taken by mouth and is used alone or in combination with other medicines to treat nasal congestion (a blocked nose) resulting from a cold, flu, or allergy.

PRES and RCVS can involve reduced blood supply (ischaemia) to the brain and may cause major and life-threatening complications in some cases. Common symptoms associated with PRES and RCVS include headache, nausea, and seizures.

The review follows new data from a small number of cases of PRES and RCVS in people using pseudoephedrine-containing medicines which were reported in pharmacovigilance databases and the medical literature.

Pseudoephedrine-containing medicines have a known risk of cardiovascular and cerebrovascular ischaemic events (side effects involving ischaemia in the heart and brain), including stroke and heart attack. Restrictions and warnings are already included in the medicines’ product information to reduce these risks.

Considering the seriousness of PRES and RCVS, the overall safety profile of pseudoephedrine and the indications for which the medicines are approved, the PRAC will review available evidence and decide whether the marketing authorisations for pseudoephedrine-containing medicines should be maintained, varied, suspended, or withdrawn across the EU.

This communication and related content are published here.

• EMA communication: Actions to support the development of medicines for children

Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and boost the development of medicines for children. These achievements are highlighted in the closing report of the EMA and European Commission (EC) action plan on paediatrics. Some of the key improvements brought by the paediatric action plan include:

• Strengthened focus on unmet medical needs: over the last four years, EMA and relevant stakeholders systematically got together to better identify and raise awareness on the areas where medicines for children are particularly needed, with a goal to shift the research agenda to these areas. For example, multi-stakeholder strategy fora to discuss and agree the needs of children with cancer, and of children with inflammatory bowel disease have taken place. The learnings from these meetings involving clinicians, paediatric patients and their representatives, academia, regulators, HTAs bodies, and developers are being considered by EMA when discussing paediatric investigation plans (PIPs) for new medicines.
• Adapting regulatory processes to better support innovation: to facilitate the establishment of PIPs, regulatory processes have been adapted and processes overall simplified. A major outcome of this work is the launch of a pilot phase for a ‘stepwise PIP’ agreement: under this framework, it will be possible in certain cases to agree on a partial development programme, conditional on the development of a full PIP once evidence becomes available over time. This will allow agreeing on PIPs for innovative medicines where crucial information needed to define certain parts of the plan is not yet available, while planning the conditions and milestones for companies to return to EMA’s paediatric committee (PDCO) and discuss the uncertainties once more data are available. More information on this newly developed framework, launched today, is provided in the guidance for a stepwise PIP pilot.
• Increased alignment of data requirements between decision-makers: to facilitate the compatibility of paediatric requirements between regulators, EMA has strengthened its collaboration with international partners, and notably within its paediatric cluster with the US Food and Drug Administration (FDA) and other international regulators. Work was also carried out through the European network of paediatric research at EMA (Enpr-EMA) to align international requirements for paediatric clinical trials authorisation and standards.

 For more details please click here.

• EMA communication: Publication on "The therapeutical potential of psychedelics: The European regulatory perspective"

The EMA shared an article on “The Therapeutical Potential of Psychedelics: The European regulatory perspective”, co-authored by EMA. This joint publication was written in collaboration with the European College of NeuroPsychopharmacology (ECNP) and the EMA’s Central Nervous System Working Party (CNSWP). It acknowledges the therapeutics potential of psychedelics and provides a scientific and regulatory perspective of EU bodies on the development and ultimately the approval of psychotherapies in the EU.

• EMA consultation: Launch of public consultation on ACT EU multi-stakeholder platform until 3rd March 2023 - Deadline: 3 March 2023

The EMA launched a public consultation concerning the development of a multi-stakeholder platform to promote collaboration for improving clinical trials in the EU as foreseen by Accelerating Clinical Trials in the EU (ACT EU) priority action 3.

This platform will enable regular dialogue between all EU stakeholders on clinical trials and facilitate the evolution of the clinical trials environment by helping to identify key advances in clinical trial methodologies, technology, and science. The platform will serve as a neutral space for the discussion of challenges and the development of practical solutions to enable and drive change. It is envisaged that there will be several phases of development before reaching its final design.

A concept paper outlining the proposal for the creation of the platform has been published together with the public consultation. The objective of which is to gauge interest in the platform, get feedback on priority topics for discussion, and provide comments on the proposal. The multi-stakeholder platform will have its kick-off meeting in Q2 2023.

The public consultation accessed using this link: EUSurvey - Survey (europa.eu) and remained open until 03 March 2023 at midnight CET.

 For more information please consult the web page Accelerating Clinical Trials in the EU (ACT EU).

EUCROF submitted feedback to this survey ahead of the deadline. For more information please contact the EUCROF Secretariat on This email address is being protected from spambots. You need JavaScript enabled to view it..

• EMA communication: "Human Medicines Highlights" Newsletter March 2023 issue

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

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

• EMA communication: Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines

EMA, the European Commission and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), are closely monitoring and responding to current shortages of antibiotics affecting the EU.

Shortages of medicines have been an ongoing public health concern and the situation in the EU has been exacerbated by geopolitical events or trends such as the war in Ukraine, the energy crisis and high inflation rates.

A recent surge in respiratory infections has led to an increase in demand for antibiotics such as amoxicillin (alone and in combination with clavulanic acid), especially as paediatric formulations. In addition, manufacturing delays and production capacity issues have led to supply problems affecting the majority of Member States. The supply issues also affect countries outside the EU, and EMA has exchanged key information with other international regulators. Various measures have been implemented at Member State level to ensure that patients can receive appropriate treatment.

MSSG and its working party, the SPOC working party, have been closely monitoring the situation since November 2022 and have been engaging with key players in the supply chain of amoxicillin to agree possible mitigating measures such as increasing manufacturing capacity. Through EMA’s engagement with its stakeholders, MSSG has received up-to-date information from community pharmacists on the situation in pharmacies across the EU.

National Competent Authorities, as encouraged by the MSSG, are making use of the regulatory flexibilities available, such as allowing the exceptional supply of certain medicines or presentations that may not be authorised in a particular Member State or granting full or partial exemptions to  certain labelling and packaging requirements to ensure that patients can receive appropriate treatment. In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding.

The European Commission, HMA and EMA are cooperating closely, to investigate whether additional measures could be undertaken to mitigate the impact of these shortages.

MSSG will continue to cooperate with  stakeholders, and the SPOC working party will continue to engage with  companies to provide regulatory support to increase supplies.

MSSG and the SPOC working party will continue to closely monitor the situation together with the European Commission and EU Member States. Based on current information from companies and stakeholders, it is expected that the situation will improve in the coming months. Patients and healthcare professionals are reminded that alternatives are available in case of shortages.

It is important that antibiotics are used prudently to  maintain their efficacy and avoid antimicrobial resistance. Antibiotics, including amoxicillin, should only be prescribed to treat bacterial infections. They are not suitable for treating viral infections such as cold and flu, where they are not effective.

MSSG stresses the importance of transparency in relation to shortages and highlights the need for all stakeholders to communicate in an objective and responsible way to avoid any undue public concern.

This communication and the related content are published here.