eNews November 2022

EUCROF is pleased to announce that Medidee Services SA, a consulting company based in Lausanne (Switzerland), has become an Associate Member. The company’s services cover all steps of product development, from initial project idea to certification or regulatory clearance. With sites in Switzerland, Germany, Denmark, Belgium, and USA, Medidee is a global services supplier serving companies of all sizes ranging from academic start-ups to majors.

Another Associate Member which joined the EUCROF family is PHA Farmed D.O.O. Based in Ljubljana (Slovenia), in alliance with investigators in clinics in Slovenia and Croatia, it is specialised in patients’ recruitment, as well as in providing bioanalytical testing and contract research support.

A warm EUCROF welcome to both Medidee Services SA and PHA Farmed D.O.O.!

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 and have been 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 September 2022 and there will be a call in November with CNIL to resolve the final mainly administrative points. Thereafter the intention is for CNIL to submit the final draft of the Code to the European Data Protection Board for approval at its December meeting, and subject to the outcome, a launch of the Code early next year. 

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’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.

Presentations of the Code of Conduct continue to be given 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)).

Our third EUCROF webinar for the year took place on Wednesday, 5 October. Its title was “Person-Centric Clinical Trials” and was successful with 30 attendees. The presenters were Ana Stojković, Vice President Clinical Operations at Optimapharm and Franck Devaux, Ethicist and Chair of the Ethics Committee.

Overview:  

A person-centric approach is a new developing concept in Clinical Trials, where all the different participating groups perspectives are considered in order to improve efficiency and overall experience.

Ethics of care provides us with applied tools to ensure human-centred perspective in the clinical trials. Perspective should be centred on patient's voices as essential discourse to reframe the way we conceive and perform CT which are overlapping with care in day-to-day practice.

 The main aim of the person centricity approach is to widen essential Patient perspective, by considering all actors in the process: Investigators, Research Nurses, Study Teams, Sponsors, CROs, especially CRAs as connecting role, Regulatory and Ethics authorities and others.

In this webinar, presenters addressed some of present perspectives model limitations with review of new tools, options, and bio-psycho-social models as gatekeeper of humanity in clinical Trials.

The fourth webinar this year took place on Tuesday, 25 October. Its title was “The Data Privacy and Regulatory Compliance Learning Curve”. The presenter was Eric Klaver, DCT Regulatory Director, IQVIA. Again, the webinar was successful with 21 attendees.

Overview:

The pandemic accelerated many sponsors to embrace decentralised clinical trial (DCT) elements for their studies faster than originally intended, demonstrating real benefits to patients, sites, and sponsors. For all the benefits DCT technology and services bring, they present additional complexities related to patient data privacy and regulatory compliance adherence that are critical align.

This webinar analysed and focused on the three following key points:

•      Build trials and protocols that meet regulatory and legal frameworks that follow data privacy laws and Good Clinical Practice (GCP) standards

 •        Understand how regulatory and privacy laws improve patient centricity impact on DCT

•         Foster a relationship with sites and give sponsors confidence that their CRO can uphold the trust of participants that is so crucial to patient centricity trials

Note, the recording of our 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..

Decentralised Clinical Trials (DCT) is an area of great interest throughout the industry at present. EUCROF have decided to join forces with the eClinical Forum and set up a Decentralised Clinical Trials Team to consider the strategic, regulatory, process and technology environment for DCT by evaluating the state-of-the-art technology, together with emerging trends. The goal of the group is to document challenges and best practices for selected individual components. Fiona Maini (Medidata) is now leading the group and although the team continues to grow, it is still open to others to apply to join.

EUCROF was invited as stakeholder to participate to the Multi-stakeholder Workshop on Decentralised Clinical Trials (DCT) on behalf of the EU DCT Project at the EMA, Amsterdam, on 4 October 2022. Collaborating Fiona Maini, represented ACRO, while Yoani Matsakis presented for EUCROF.

 The plenary session was recorded and can be found via this link.

If you are interested and wish to receive more information, contact the EUCROF Secretariat (Assia Rosati) via This email address is being protected from spambots. You need JavaScript enabled to view it..

• As part of the Real-World Data & Digital Health Working Group, this Task Force has been established in response to the increasing resourcing challenges being faced by the CROs and the Clinical Research industry as a whole, in recruiting individuals with the experience and skills required to fill the many vacancies available and attracting sufficient newly trained talent into the sector. This global situation is particularly highlighted by the shortage of Clinical Research Associates in Europe at this time but there are also recruitment challenges being seen in many other job categories within the industry, such as regulatory and quality.

   

  The Task Force currently has representatives from several countries ((Belgium, Czech Republic, France, the Netherlands, Romania, Sweden, and the UK), and each person acts as the country coordinator. The Task Force would be pleased to welcome new representatives from countries currently not covered. The overall purpose of the Task Force is to get a better understanding of the reasons creating the challenges with the lack of resource in the industry and identify ways in which EUCROF could assist in the future in areas such as training and collaboration with, for example, universities to facilitate an increase in the talent pool available.

   

  If you are interested and wish to receive more information, contact the EUCROF Secretariat (Assia Rosati) via This email address is being protected from spambots. You need JavaScript enabled to view it..

• • 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 been recently issued by the EMA to help all stakeholders to effectively use the new CTIS.

    • Announcement of the CTIS release version

    EMA is pleased to announce the release of CTIS version 1.0.6.0. Please find below more information on this announcement.

     

    EMA regularly performs technical updates to CTIS to improve its features and functionality. When significant updates are made to CTIS, EMA publishes release notes that outline what has changed in the system. Updates may include improvements to existing features and functionality, the addition of new features and functionality and technical improvements.

    An improvement to role assignment has been implemented in CTIS. The Administrators have now to indicate both the user ID and the email address of the user to whom they wish to assign a role. This is effective only for new roles being assigned.

    In addition, EMA publishes known issues that sponsor, and authority users may encounter when using the CTIS secure workspaces. Where possible, workarounds to apply are proposed.

    The latest version of the release notes and known issues documents can be found on the ‘Website outages and system releases’ page of euclinicaltrials.eu

     

    • Organisation Management System (OMS) Trouble Shooting Sessions for CTIS users

     

    The EMA has organised several events during the year to support CTIS users with OMS-related questions. Events are broadcast live, the most recent one being on 22 September (details of the event page).

     

    The calendar of the sessions is shown below:

    Session	Event Date	Due date for questions	Event page link	Time (one hour)
    2nd	21 July 2022	14 July 2022	Event page	14:00 – 15:00
    3rd	22 September 2022	15 September 2022	Event page	14:00 – 15:00
    4th	19 October 2022	12 October 2022	Event page	14:00 – 15:00
    5th	24 November 2022	17 November 2022	Event page	14:00 – 15:00

    
    

  • In preparation for this session, the EMA captured questions via Slido. Questions were answered by speakers during the panel session.

• EMA communications on Monkeypox and COVID-19 vaccines 

• We would like to share with you the EMA’s recent communications on Monkeypox and COVID-19 vaccines:

   

  • EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against monkeypox
  • EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine

    

  • Updates on Scientific Advice and Clinical Trials to respond to the ongoing monkeypox outbreak

   

  The European Medicines Agency (EMA) has initiated a series of actions to respond to the ongoing monkeypox outbreak, which has been escalated by the World Health Organization (WHO) to a Public Health Emergency of International Concern (PHEIC) on Saturday 23 July. This is the first new PHEIC to be declared since the regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices has become applicable (press release).

   

  Please find here the links to the latest updates on the EMA Scientific Advice and protocol assistance and the Clinical Trials webpages.

   

  • Publication of the revised EU GMP Annex 1 on Manufacture of Sterile Medicinal Products

   

  Following extensive review and consultation, the European Commission has published the revised good manufacturing practice Annex 1 on the manufacture of sterile medicinal products for human and veterinary use.

  The guideline was reviewed by EMA in collaboration with the Pharmaceutical Inspection Co-operation Scheme (PICs) and WHO. Important changes to the new guideline include new sections on Pharmaceutical Quality System (PQS), utilities and technologies, and the introduction of a requirement for companies manufacturing sterile product to apply the principles application of quality risk management (QRM), and to have a contamination control strategy (CCS) across their facilities. In addition, the guideline has further been restructured to include a detailed roadmap for manufacturers, providing a more logical flow of information and guidance for the use of new technologies, which may increase efficiency and reduce the risk of contamination or quality defects. The new guideline will come into effect on 25 August 2023, with the exception of point 8.123 which has been postponed until 25 August 2024.

  The revised EU GMP Annex 1 can be found here.

    

  • EMA public consultation on herbal medicines

   

  The European Medicines Agency has published for public consultation the following documents on herbal medicines:

   

  • European Union herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus
  • List of references supporting the assessment of Juniperus communis L., pseudo-fructus (galbulus)
  • Assessment report on Juniperus communis L., pseudo-fructus (galbulus)
  • European Union herbal monograph on Juniperus communis L., pseudo-fructus (galbulus)
  • List of references supporting the assessment of Foeniculum vulgare Miller subsp. vulgare var. vulgare and var. dulce (Mill.) Batt. & Trab., fructus
  • Assessment report on Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Mill.) Batt. & Trab., fructus
  • European Union herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. dulce (Mill.) Batt. & Trab., fructus
  • List of references supporting the assessment of Foeniculum vulgare Miller subsp. vulgare var. vulgare, aetheroleum
  • Assessment report on Foeniculum vulgare Miller subsp. vulgare var. vulgare, aetheroleum
  • Public statement on Foeniculum vulgare Miller subsp. vulgare var. vulgare, aetheroleum

   

  Deadline for comments: 30 November 2022. Please send your comments to This email address is being protected from spambots. You need JavaScript enabled to view it. by using the standard template.

    

  • CIOMS report on patient involvement in the development, regulation, and safe use of medicines

   

  The EMA has shared the CIOMS report on “patient involvement in the development, regulation and safe use of medicines”, which is available as a free download.

    

  The report is the result of four years of work with patient group leaders, academics, industry experts, regulators, and other stakeholders, and EMA is pleased to have been involved.

  It describes the importance of systematically involving patients throughout a medicine’s lifecycle, from early development through the regulatory process to ongoing monitoring and safe use in everyday healthcare and provides a comprehensive overview of current knowledge about the benefits of patient involvement and existing initiatives, with examples and recommendations, and addresses the remaining challenges and practice gaps. The aim of the report is to prompt readers to implement its best practice recommendations according to how well they fit in with their organisational and national needs.

   

  • SAVE THE DATE: 3rd EU Big Data Stakeholder Forum - 1 December 2022

   

  HMA-EMA Big Data Steering Group will hold the 3rd EU Big Data Stakeholder Forum” on Thursday, 1 December 2022.

   

  The objectives of this meeting include to:

  • inform stakeholders on the delivery of data activities of the Network Strategy 2025.
  • continue engagement with stakeholders and strengthen collaboration.
  • look to the future including new legal proposals.

   

  We anticipate space for a broad representation of stakeholders, and attendance will be organised through EU associations and by direct invitation. To enable wide participation the Forum will be broadcast, and a recording made public.

  An outline of the agenda and details on the registration process will be available closer to the date.

  Please do not hesitate to contact This email address is being protected from spambots. You need JavaScript enabled to view it. should you have any queries.

   

  • EMA consultation: Draft ICH Guideline M12 on drug interaction studies

   

  The European Medicines Agency has published for public consultation a “Draft ICH Guideline M12 on drug interaction studies”.

   

  This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical pharmacokinetic drug-drug interaction (DDI) stu-dies during the development of a therapeutic product. These aspects in general apply to the development of small chemical molecules. DDI evaluation of biologics is only covered briefly, with focus on monoclonal antibo-dies and antibody-drug conjugates. Guidance is provided on how to investigate interactions mediated by inhibition or induction of enzymes or transporters, both in vitro and in vivo, and on how to translate the results to appropriate treatment recommendations. The guideline also includes recommendations on how to address metabolite-mediated interactions. The use of model-based data evaluation and DDI predictions are also covered.

  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 21 November 2022.

   

  • EMA communication: "Human Medicines Highlights" Newsletter – October 2022 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 consultation: Draft Qualification opinion for the iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating novel immunosuppressive medicines in kidney transplant patients

   

  The European Medicines Agency has published for public consultation a “draft qualification opinion for the iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating novel immunosuppressive medicines in kidney transplant patients”.

   

  CHMP qualifies the iBox Scoring System (Composite Biomarker Panel) as a secondary endpoint prognostic for death-censored allograft loss (allograft failure) in kidney transplant recipients to be used in clinical trials to support the evaluation of novel immunosuppressive therapy applications.

  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 17 November 2022.

   

  • EMA communication: Follow-up of workshop on Patient Experience Data in EU medicines development and regulatory decision-making held on 21 Sept 2022

   

  The European Medicines Agency organised a “workshop on Patient Experience Data in EU medicines development and regulatory decision-making” on 21 September 2022.

  This multistakeholder workshop brought together patients, healthcare professionals, academia, regulators, and industry to discuss ways to improve the collection and use of patient experience data to achieve patient-centred medicine development and regulation.

  We are pleased to share with you the presentations, video recording and the report of the workshop which summarises the outcome of the discussions and the actions agreed to progress on Patient Experience Data in the European Union. The documents have been published here.

    

The task force is working on drafting the article “The importance of CROs in Clinical Research”, based on the results of a survey which has been distributed (52 CROs answered). The survey will be implemented in the article, which should be ready by the end of the year 2022, so keep looking at EUCROF’s website for this news! 

As discussed in the GA in June, EUCROF would want to apply for funding in order to support its growth and the numerous activities undertaken. Examples of activities are the conference, GDPR CoC, task forces, etc.

In that respect, we are looking for volunteers to create a Funding Task Force who would look into possible funding for EUCROF. The task force would look at potential opportunities and identify a possible company specialised in funding to support the funding applications.

Please send your kind willingness to contribute by end of November 2022. 

Should you have any further question, please do not hesitate to contact This email address is being protected from spambots. You need JavaScript enabled to view it. or the members of the EUCROF Executive Board.