eNews April 2022

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

CTIS newsflash #11 - 22 April 2022.

Welcome to the 11^th and final CTIS newsflash. This newsflash provides updates on key facts and figures regarding CTIS usage, as well as links to useful reference materials.

Note on the CTIS newsflash

As of May 2022, the weekly CTIS newsflash will be replaced with a monthly clinical trials metrics report, which will be available on the EMA website.

Key metrics

Metrics reported cover the period 11/04/2022-17/04/2022.

• Total number of logins to CTIS: 13,503
  • This metric represents the total sum of unique logins by individual users per day at the end of the period
• Number of draft applications in CTIS: 366
  • This metric counts the number of applications with status “Draft” in CTIS at the end of the period
• Number of submitted applications in CTIS: 31
• Number of authorised applications in CTIS: 2

News spotlight

The second clinical trial has been authorised through CTIS. It is the first clinical trial initiated via CTIS, i.e. a trial that was not previously ongoing under the Clinical Trials Directive which has begun under the regime of the Clinical Trials Regulation via submission to CTIS. The Member State concerned in the trial is Denmark. Patients, healthcare professionals and members of the public can see relevant information about the clinical trial in the CTIS public search such as the estimated recruitment start date, inclusion and exclusion criteria and sponsor details.

View Clinical Trial - EMA (euclinicaltrials.eu)

More information about CTIS and the CTIS public search is available at https://euclinicaltrials.eu/home.

Did you know?

CTIS allows sponsors to upload ‘for publication’ and ‘not for publication’ versions of certain documents, including the protocol and the investigator brochure. This functionality allows sponsors to protect personal data and Commercially Confidential Information (CCI) in CTIS by only providing such information in the ‘not for publication’ versions of the documents. Draft guidance on the protection of personal data and CCI in CTIS can be found below.

Protection of personal data and Commercially Confidential Information in CTIS – open consultation

To assist sponsors and authority users in fulfilling the transparency requirements set out in the Clinical Trials Regulation, EMA is preparing a dedicated guidance on the protection of personal data and CCI in CTIS.

EMA has published a draft of the guidance for open consultation to allow for wider stakeholder input and to account for experience gained in working with CTIS. The draft guidance and details on how to provide feedback can be found on the CTIS training and support page. The deadline to comment is 8 September 2022.

Clinical Trials Information System: training and support | European Medicines Agency (europa.eu)

A stakeholder workshop will be held during the public consultation period, further details will be shared in the Clinical Trials Highlights newsletter when available.

CTIS April bitesize talk topic changed to RFIs

The third CTIS bitesize talk took place on 28 April. The topic of the bitesize talk has been changed to requests for information (RFIs) to provide sponsors with practical guidance on how to respond to requests for information received from Member States when they are evaluating an initial clinical trial application.

Clinical Trials Information System (CTIS) bitesize talk: Requests for information | European Medicines Agency (europa.eu)

More information

Users can review Module 22 – Introduction to CTIS for public users for more information on the searching CTIS as a public user.

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

Would you like to unsubscribe from the CTIS newsflash? Please write to This email address is being protected from spambots. You need JavaScript enabled to view it. with the subject line ‘Unsubscribe from CTIS newsflash’. This will also unsubscribe you from the Clinical Trials Highlights Newsletter.

EMA is committed to personal data protection. Any personal data is processed in line with the Regulation (EU) 2018/1725. For more information you may consult the European Medicines Agency’s privacy statement for electronic newsletters. DRAFT_EMA Privacy statement on newsletters (europa.eu)

• Note on CTIS: CTIS and related systems planned maintenance

CTIS has regular maintenance windows to ensure technical updates to the system can be implemented in a timely manner. In addition to this, systems that CTIS interacts with undergo regular and ad-hoc maintenance which may affect CTIS usage.

Please find below updates on the regular CTIS maintenance windows, and scheduled maintenance of OMS and EudraCT which will affect CTIS usage for a limited period of time.

These updates will be reflected shortly on the Website outages and system releases page on the Clinical Trials website.

Website outages and system releases - EMA (euclinicaltrials.eu)

Each Tuesday: 18:00 – 21:00 Amsterdam time

During this maintenance period, CTIS may be intermittently unavailable.

In addition, EMA’s Organisation Management System (OMS) undergoes weekly maintenance in the same period. During the OMS maintenance, CTIS users cannot perform the below actions. Error messages will be displayed for many of these actions indicating that OMS is not available.

• User administration:
• Updating your employer data
• Assigning or requesting a role
• Assigning a role to a Member State National Organisation Administrator (NOA)
• Clinical trial application:
• Creating a new clinical trial initial application
• Adding a sponsor to a clinical trial initial application
• Adding a contact point for Scientific Advice, or as a Legal Representative or Third Party
• Adding a trial site to part II of the application
• Other:
• Adding a site to an inspection
• Creating a new Annual Safety Report

Each Thursday: 18:00 – 21:00 Amsterdam time

During this maintenance period, CTIS may be intermittently unavailable.

Each first Saturday of the month, starting in March, from 10:00 – 14:00 Amsterdam time

During this maintenance period, CTIS may be intermittently unavailable.

Friday 4 March 18:00-Saturday 5 March 12:30 Amsterdam time

During this maintenance period, EudraCT will undergo scheduled maintenance. During this maintenance period, CTIS users cannot perform the below actions in CTIS. No error message will be displayed in CTIS for these actions.

• Linking the EudraCT clinical trial application to the clinical trial application in CTIS in the case of transition trials

• Adding EudraCT trials using the associated clinical trials functionality, in the CTIS clinical trial application

• MA communication: "Clinical Trial Information System (CTIS) walk-in clinics"

EMA is introducing 'CTIS walk-in clinics', a series of short, regular events that provide an opportunity for the Clinical Trial Information System (CTIS) sponsors to consult EMA's CTIS experts and ask them questions about CTIS functionalities in a live forum. Questions about the interpretation of the Clinical Trials Regulation and/or national processes are out of the scope of this event.

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. It will be live broadcast and no registration is required.

These one-hour clinics will happen every two weeks. A video recording will be made available after each event. To make the best out of the walk-in clinics, attendees are highly recommended to first consult the available CTIS online training and support materials, including the CTIS Sponsor Handbook.

Clinical Trials Information System: training and support | European Medicines Agency (europa.eu)

Clinical Trials Information System: training and support | European Medicines Agency (europa.eu)

• Open consultation on guidance document for the protection of personal data and Commercially Confidential Information (CCI) in CTIS

To assist sponsors and authority users in fulfilling the transparency requirements set out in the Clinical Trials Regulation, EMA is preparing a dedicated guidance on the protection of personal data and CCI in CTIS.

EMA has published a draft of the guidance for open consultation to allow for wider stakeholder input and to account for experience gained in working with CTIS. The draft guidance is available on the EMA open consultations page. The consultation on the draft guidance will remain open until 8 September 2022.

Open consultations | European Medicines Agency (europa.eu)

A stakeholder workshop will be held during the open consultation period, further details will be shared when available.

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.

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

The new Clinical Trials Logistics Working Group, promoted by our Associated Member, Michael Shumilin, has been formally launched.

In summary, 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 specialized 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! For more details on the goals and planned activities of the CTLog WG. 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 Michael Shumilin directly via his email address: (This email address is being protected from spambots. You need JavaScript enabled to view it.).

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 2022, thereafter the companies wishing to adhere to the Code may start the adherence process.

Consult the EUCROF website for future updates on this important initiative where you will see a press release that was published on our website entitled:

“The European CRO Federation (EUCROF) announces the launch of its electronic submission and approval platform for future adherents to the EUCROF GDPR Code of Conduct for Service Providers in Clinical Research (the EUCROF Code)” (Latest News (eucrof.eu)).

The start of 2022 has been remarkably busy with colleagues representing EUCROF at multiple meetings across a number of topics. In the last few months EUCROF has been represented at the following meetings: -

• CTIS Expert Group and Stakeholders Meeting (virtual) on 3 February 2022, where Dr Dehlinger-Kremer, Simon Lee and Dagmar Chase represented EUCROF in what will probably be the last CTIS Meeting
• EUCROF President, Dr Martine Dehlinger-Kremer, has been invited to ACRO’s 20^th anniversary celebration, which was held in Washington DC on 16 March 2022. EUCROF is thankful to ACRO for the opportunity to attend that wonderful event.
• 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 gave 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 were invited guests by the Ministry of Health, and presented respectively on "International regulations: impactful news from the last 3 years" and “"GDPR Code of Conduct" respectively.

Our thanks to all those who have represented EUCROF so far in 2022. It is anticipated that 2022 could be a busy year for meetings post the COVID-19 pandemic, so look out in Forthcoming Events, in this and future newsletters, for information on these events.

• EMA Guidance on Covid-19

An EU4Health Joint action for expedited assessment of multinational COVID19 trials started from February 2022.

In order to provide potential developers and clinical trial sponsors with information about this joint action, the coordinators and the steering committee organized an info session to stakeholders, which took place between on 3 February.  

EU4H-2021-JA-01

Link: https://scic.ec.europa.eu/ew/register/dgscic/JA_02_22/e/lk/g/36170/k/

The Joint Action has been set up to implement the EU Strategy on COVID19 therapeutics: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021DC0355R(01)&from=EN

It will be financed under EU4Health managed by HADEA:  https://ec.europa.eu/health/funding/eu4health-2021-2027-vision-healthier-european-union_en

The Guidance Document issued by the EMA encourages all Member States to adopt the provisions.

The most up to date information can be found at

https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/covid-19-whats-new.

• EMA communication: Updates on COVID-19 vaccines

 All the latest updates on COVID-19 vaccines and treatments are available by clicking here.

• EMA Consultation:  Call for scientific data for the periodic review of herbal monographs

• The Committee on Herbal Medicinal Products (HMPC) invites all interested parties to submit any scientific data that the HMPC should consider at the periodic review of the 8 monographs listed below towards a possible revision of the monographs and its supporting documents. The publication of this call is the first step in the procedure established by the committee so that adopted monographs remain up to date:

  • Matricariae flos, Helichrysi flos, Ginkgo folium, Eschscholziae herba, Epilobii herba, Crataegi folium cum flore, Capsici fructus & Agrimoniae herba

  Scientific contributions should be sent by email to This email address is being protected from spambots. You need JavaScript enabled to view it. by 14 May 2022.

   

• EMA communication: EMA starts safety review of Janus kinase inhibitors for inflammatory disorders

• EMA’s safety committee, PRAC, has started a review of the safety of Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis and atopic dermatitis).

  The review was prompted by the final results from a clinical trial (study A3921133) of the JAK inhibitor Xeljanz (tofacitinib). The results showed that patients taking Xeljanz for rheumatoid arthritis and who were at risk of heart disease were more likely to experience a major cardiovascular problem (such as heart attack, stroke or death due to cardiovascular disease) and had a higher risk of developing cancer than those treated with medicines belonging to the class of TNF-alpha inhibitors. The study also showed that compared with TNF-alpha inhibitors, Xeljanz was associated with a higher risk of death due to any cause, serious infections, and blood clots in the lungs and in deep veins (venous thromboembolism, VTE).

  In addition, preliminary findings from an observational study involving another JAK inhibitor, Olumiant (baricitinib), also suggest an increased risk of major cardiovascular problems and VTE in patients with rheumatoid arthritis treated with Olumiant compared with those treated with TNF-alpha inhibitors.

  In the treatment of inflammatory disorders, Olumiant and other JAK inhibitors work in a similar way to Xeljanz. PRAC will therefore carry out a review to determine whether these risks are associated with all JAK inhibitors authorised in the EU for the treatment of inflammatory disorders and whether the marketing authorisations for these medicines should be amended.

  Some measures to minimise these risks are already in place for Xeljanz as result of a review finalised in 2020, which analysed the interim results of study A3921133. In addition, the product information for Xeljanz was further updated in 2021 to reflect the increased risk of major cardiovascular problems and cancer observed after the release of additional data from this study.

  This communication and related content have been published here.

   

• MA communication: Launch of the establishment phase of DARWIN EU® and the initiation of the Coordination Centre

• EMA is initiating the establishment of the Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®) – see EMA press release Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU | European Medicines Agency (europa.eu).

  Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU | European Medicines Agency (europa.eu)

  The vision of DARWIN EU® is to support EU regulatory decision-making on the development, authorisation and surveillance of medicines, by giving EU medicines regulators access to valid and trustworthy real-world evidence, for example on diseases, patient populations, and the use, safety and effectiveness of medicines including vaccines throughout the lifecycle of a medicinal product.

  By supporting decision-making on medicines, a wide range of stakeholders will benefit, from patients and healthcare professionals to health technology assessment bodies, payers, and the pharmaceutical industry. Additionally, DARWIN EU® will provide an invaluable resource to prepare for and respond to future healthcare crises and pandemics.

  DARWIN EU® will also act as a pathfinder for the European Health Data Space (EHDS) and will ultimately connect to the EHDS services, enabling the use of the EHDS in the context of medicines regulation in Europe. https://ec.europa.eu/health/ehealth-digital-health-and-care/european-health-data-space_en.

  ABOUT THE COORDINATION CENTRE

  The role of the Coordination Centre is to develop and manage a network of real-world healthcare data sources across the EU and to conduct scientific studies requested by medicines regulators and, at a later stage, requested by other stakeholders.

  EMA will be working with Erasmus University Medical Center Rotterdam to establish the DARWIN EU® Coordination Centre. The contract was awarded to them following a call for tender published in June 2021.

  ABOUT THE ESTABLISHMENT PHASE

  EMA will begin working with the Coordination Centre to ensure that the first DARWIN EU® pilot studies are delivered in 2022. EMA will set standards, oversee the Coordination Centre, connect it to the work of the EMA medicines committees and monitor its performance. 

   

• EMA communication: EU recommendations for 2022-2023 seasonal flu vaccine composition

• EMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2022.

  Please click here for details on the virus strains and related content.

   

• EMA consultation: ICH guidelines Q2(R2) and Q14 on analytical procedures

• The European Medicines Agency has published for public consultation two ICH guidelines:

  • ICH guideline Q2(R2) on validation of analytical procedures

  ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf (europa.eu)

  This guideline applies to new or revised analytical procedures used for release and stability ICH Q2(R2) Guideline testing of commercial drug substances and products (chemical and biological/biotechnological). The guideline can also be applied to other analytical procedures used as part of the control strategy (ICH Q8-Q10) following a risk-based approach. The scientific principles described in this guideline can be applied in a phase-appropriate manner during clinical development. This guideline may also be applicable to other types of products, with appropriate regulatory authority consultation as needed.

  • ICH guideline Q14 on analytical procedure development

  ich-guideline-q14-analytical-procedure-development-step-2b_en.pdf (europa.eu)

  This guideline applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological/biotechnological). The guideline can also be applied to other analytical procedures used as part of the control strategy (ICH Q10, Pharmaceutical Quality System) following a risk-based approach. The scientific principles described in this guideline can be applied in a phase-appropriate manner during clinical development. This guideline may also be applicable to other types of products, with appropriate regulatory authority consultation as needed. Development of pharmacopoeial analytical procedures is out of scope.

  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. 31 July 2022.

  ​Launch of GCP inspections management in IRIS platform

• The management of GCP inspections in IRIS went live on 6 April 2022 (see Good Clinical Practice | European Medicines Agency (Europa.eu) and Pharmaceutical industry | European Medicines Agency (europa.eu)). 

  The new system is a key milestone within the Agency’s digital transformation programme and is expected to streamline the EMA inspection co-ordination process, improving efficiency, transparency, and security.

  IRIS GCP inspections management will have key benefits for all users of the system: EMA, EU/EEA regulatory medicines network and Industry stakeholders (Applicants/MAHs). The benefits relevant and/or specific to Industry stakeholders are listed below: 

   

  1.    Efficiency gains  

  • Harmonisation across different inspections types (GMP, GCP and later in 2022 PhV inspections will be managed through the IRIS platform); 
  • Automation of notifications to Applicants/MAHs (all notifications will now be sent through the IRIS platform); 
  • Increased data quality through integration with other EMA systems, making use of already available SPOR (Substances, Products, Organisations and Referentials) master data.

  2.    Increased security, reducing the risk of unintentional disclosure of confidential information

  •             Streamlined and secured processes for information exchange.

  3.    Better knowledge management

  • Easier access to and retrieval of all inspections data in the context of Centralised Procedure available from one single platform, also providing users with search functionalities.

   

  Change management:

  A recording from the training session on GMP and GCP for Industry users is available from the IRIS portal section “Additional guidance & training videos”.

  Access and contacts for GCP Inspections:

  The contact person receiving the notification of a GCP inspection is the “Person authorised for communication on behalf of the applicant during the procedure in the EU/EEA” as indicated in section 2.4.2 of the eAF for Marketing Authorisation Applications and “Person authorised for communication between the marketing authorisation holder and the competent authorities after authorisation” as indicated in section 2.4.3 of the eAF for any type of inspection linked to a variation.

  For each Inspection, a new “submission” is created. To access this submission, and provide documents when requested, all product contacts must have an IRIS Industry Manager role, affiliated to the Marketing Authorisation Holder/Applicant of the product.

   

  If you already have access to IRIS and are affiliated as Industry Manager to the organisation location of the product, no further action is requested from your side.

  If you do not have access to IRIS, or you do not have an affiliation to the Marketing Authorisation Holder / Applicant, you should request it as soon as possible.

   

  Further information:

  As you may already know, EMA is currently working on the onboarding of Pharmacovigilance (PhV) inspections in IRIS, which are expected to go live later in 2022. 

  More information on the use of the system can be found in the updated IRIS guide for applicants and in the Guidance for applicants/MAHs involved in GMP and GCP inspections co-ordinated by EMA. 

   

• EMA consultation: Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6

• The European Medicines Agency has published for public consultation the “Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6”.

  Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances are associated with specific concerns because of their persistence, their ability to accumulate in the environment and in living organisms, as well as their toxicity. Due to the combination of these intrinsic properties and possible redistribution across environmental compartments, PBT/vPvB substances can give rise to toxic effects over a longer time and a greater spatial scale than substances without these properties. The effects of persistence/bioaccumulation are unpredictable in the long-term. In the case of vPvB substances specifically, even if limited toxicity is demonstrated in laboratory testing, there is a concern that long-term effects may be possible since, over time, high concentrations may be reached in the environment or in animals at the top of the food chain.

  The purpose of this reflection paper is to establish criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6.

  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 31 May 2022.

  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.

• EMA communication: Hydroxyethyl-starch solutions for infusion recommended for suspension from the market

• On 11 February 2022, EMA’s safety committee, PRAC, recommended that the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union. These products were authorised as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss.

  The safety of HES solutions for infusion was reviewed in two separate procedures in 2013, and a number of restrictions and measures to minimise the risk of kidney injury and death in certain patients (those critically ill, with burn injuries or with sepsis, a bacterial infection in the blood) were put in place at the time.

  As a result of a third review conducted in 2018, the use of HES solutions for infusion was further restricted to accredited hospitals, and healthcare professionals prescribing or administering the medicines had to be trained in their appropriate use. Additionally, further warnings were introduced in the product information to remind healthcare professionals that these medicines must not be used in patients with sepsis or kidney impairment or in other vulnerable patients such as the critically ill. These measures were put in place to ensure that HES solutions for infusion were not used in patients who were at increased risk of harm. Companies marketing HES solutions for infusion were also requested to conduct a drug utilisation study to check whether these restrictions were adhered to in clinical practice, and to submit the results of this study to EMA.

  The PRAC reviewed the results from this study, which show that HES solutions for infusion are still being used outside the recommendations included in the product information. The Committee concluded that the further restrictions introduced in 2018 have not sufficiently ensured that the medicines are used safely, and that HES solutions continue to be used in certain groups of patients in whom serious harm has been demonstrated.

  Since adherence to the set of measures agreed in 2018 was a condition for the safe use of HES solutions for infusion, and the study has shown this has not happened, the benefits of these medicines are no longer considered to outweigh their risks. The PRAC explored the possibility of introducing additional measures to ensure HES solutions are used according to the product information but concluded that there were no other measures, or combination of measures, that would be feasible and sufficient to protect patients. In view of the serious risks that certain patient populations are still exposed to, the PRAC therefore recommended the suspension of the marketing authorisations for HES solutions for infusion in the EU.

  The PRAC recommendation was sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which adopted its position on 23 February 2022. As the CMDh position was adopted by majority vote, it will now be sent to the European Commission, which will take an EU-wide legally binding decision in due course.

  For more details including information for patients and healthcare professionals, please click here.

• EMA communication: "Human Medicines Highlights" Newsletter - April 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.

  • Public consultation: Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum III – Pregnancy prevention programme and other pregnancy-specific risk minimisation measures

  The European Medicines Agency has published for public consultation a “Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum III – Pregnancy prevention programme and other pregnancy-specific risk minimisation measures”.

  This new guidance defines the elements of a pregnancy prevention programme and provides for deciding when such programme is needed or other risk minimisation measures are considered appropriate to avoid adverse pregnancy outcomes due to use of medicines and to preserve health of both the mother and the child.

  If you are interested in participating in the public consultation, please submit your comments via the EU survey tool linked here by 31 May 2022.

• The “Site Collaboration Group” was created towards the end of 2021 by the Working Group Clinical Trial Centres with the objective to involve sites in the discussion  on various topics relevant to Research Sites/ Clinical Trial Centers.

  Its objectives are multiple: to be a liaison and profiling of the EUCROF WG CTC towards Pharmaceutical and Medical Device Industry, to bring synergies between CROs and Research Sites / Clinical Trial Centers / Units, to define the Clinical Trial Centers’ expectations and classification, to map the problems encountered during Ethics Committee reviews, to see how to prepare them according to lessons learned, to link with European Ethics Committee organizations, to consider Safety definitions and reporting requirements, to see the impact on the research sites, the approaches in pre-and post-market setting, to look for needs, exchange and standardizations for Trainings, to help in Contracts timelines, negotiation and budget issues.

  Ideally, there should be a strong emphasis on cooperation and linking with the other existing working groups within EUCROF (e.g., Pharmacovigilance, Medical Devices, Education & Training, New Technologies, Innovative Medicine, etc.).

  The first meeting was held on February the 24th 2022; the second one on March the 24th 2022. Frequency of sites meetings should be on a monthly basis.

  Countries involved at the moment are Poland, UK, France, Austria, Italy, Netherlands and Turkey.

  But of course we look forward welcoming more countries and more sites for a more profitable brainstorming leading to profitable ideas and actions to the sites in their clinical trials activity.

  Creating a team of European Sites, we need to obtain the site perspective on various topics. The biggest challenge we have discovered is that the landscape of sites is very diverse. Not only are there the stand-alone, fully dedicated research sites, but also not fully dedicated sites, GPs, hospitals, national networks, international networks. And on top of that there are the differences between countries. Setting up a ‘team’ of site representatives from different kinds of sites from various countries would lead the sites to be able to provide their input on other initiatives from EUCROF, providing a site perspective. We have experienced this in the Working Group by participating to the Task Force on ‘remote SDV’. This ‘team’ of sites will also be able to suggest issues that could be addressed by EUCROF and its working groups. Topic Ideas are:

  • Training; needs and exchange, standardizations
  • Jobs at sites, site structure
  • Contracts; timelines, negotiation, budget issues
  • Decentralised trials
  • GDPR
  • e-Consent

     

   EUCROF Clinical Trial Centre Working Group – Members

  Atoinette van Dijk (CH) Chair Clinical & Medical Affairs Director D.O. Research	Vivienne van de Walle (NL) Co-Chair Medical Director PTR&NU	Şebnem Yaşaroğulları (TUR) VP Clinical Operations MENE Health Group	Ornela Cullufe (Alb) Project Manager CVBF	Claudine Richon (F) Business Development Director Ennov