eNews August 2022

EUCROF held its Spring General Assembly on Thursday 9 and Friday 10 June 2022 in Prague (Czech Republic). The meeting was held as a hybrid event, and a great success with 18 attendees in person and 25 virtual participants, representing 18 countries. It was a great pleasure to finally meet in person many friends and colleagues, after the last General Assembly, dating back in 2019.

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

EUCROF Interim Progress Report (2022) (Executive Board)

EUCROF Conferences

EUCROF File Sharing

GDPR Code of Conduct

Presentation of Associations

EUCROF 2022 (Dec 2021 - Dec 2022) Objectives and Priorities

Revision of EUCROF Membership Fee

Presentation of Members at the GAs

Presentation of new potential Members

Working Groups’ Outcomes

EU Benchmarking 2023 planning

Clinical Research Workforce Demand & Constraints

Presentation of OCT – Clinical

Presentation of the Lithuanian GCP&RA Association

Ukraine & Russia – Discussion on the impact on clinical trials, sharing of experience

Fall General Assembly: Location Confirmation

EUCROF Conference in 2024 - location

Brexit – Discussion on any ongoing implications to clinicals trials

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 the EUCROF website.

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 bitesize talks

There have been a number of CTIS bitesize talks in recent months.

The EMA’s CTIS bitesize talk on 23 June 2022 focused on ‘Transitional trials’ and ‘Additional Member State concerned (MSC) application’ in CTIS.

Also, the video recording of the third talk on ‘Requests for information’ has been published on the Agency’s YouTube channel, with an embedded link to the recording on the event page.

Last month’s CTIS bitesize talk on 20 July, focused on Deferral rules and Public website in CTIS.

Through the regular events CTIS bitesize talks, sponsors are offered the opportunity to learn about different functionalities in CTIS and ask questions during live Q&A sessions. This public event is open to everyone and can be followed via live broadcast (link on event page, no registration required).

• EMA communication: Clinical Trials Information System (CTIS) information and support events

The EMA held a quarterly system demo on Tuesday 28 June.

The event was a live broadcast. The broadcast link is available on the event page on EMA website: Quarterly system demo - 2022 | European Medicines Agency (europa.eu).

A video recording was made available on the same page after the event.

This is the second system demo of 2022, the third ever held by EMA as part of its agile transformation. A system demo is an event held at the end of a programme increment (a three-month period of work) to demonstrate the developments achieved in that period and collect stakeholder feedback.

Participants have the opportunity to review what has been delivered, comment and ask questions on future product increments (planned chunks of work on the final system).

The recording of the first system demo which was held on 15 March 2022 is available here.

On 30 June 2022, EMA held the first Organisation Management Service (OMS) troubleshooting session for CTIS users to clarify outstanding questions reported by CTIS users and clinical trial sites.

These sessions are being held monthly for a period of six months. In the sessions, OMS experts will address issues and questions from CTIS users related to registering organisation and/or location data in OMS for use in clinical trial applications. CTIS users are invited to submit questions via Slido prior to each session. The sessions are a live broadcast, and a video recording is made available after each session. The event pages for subsequent troubleshooting sessions will be published in due course, interested stakeholders are advised to check the Training and information events section of the CTIS training and support page for information on future sessions.

On 1 July 2022, EMA hosted a CTIS webinar for clinical trial sponsors.

The event included presentations from Member States and a sponsor representative on their first experiences in CTIS, and will also provide an opportunity for users to look forward to the end of the first year of the transition from the Clinical Trials Directive to the Clinical Trials Regulation. In addition, information on CTIS usage, training and support will be provided. CTIS users are invited to submit questions via Slido prior to the webinar. The webinar was a live broadcast, and a video recording is available after the event.

• 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.

EUCROF’s Clinical Trial Legislation Working Group has reviewed and prepared comments to this consultation.

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) Webinar: 6 months of CTIS and looking forward

EMA hosted a CTIS-focused webinar on 1 July 2022, “Clinical Trials Information System (CTIS) Webinar: 6 months of CTIS and looking forward”.

 EMA organised this open event to share user perspectives on first experiences in CTIS and to provide a forward-looking view of CTIS usage, training, and support. In addition, the event reminded sponsors of the obligation to use CTIS to submit all initial clinical trial applications starting 31 January 2023, in accordance with the transition period outlined in the Clinical Trials Regulation.

This event was open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations, but please note that the presentation material is focused on the needs of clinical trial sponsors.

• Announcement of the release of a new version of the CTIS

EMA announced the release of CTIS version 1.0.3.2. 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.

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

On Thursday, 21 July 2022, EMA organised an event to support CTIS users with OMS-related questions. The event was broadcast live (details of the event page).

This was the second event in a series of 6 months. It aims at clarifying OMS outstanding questions reported by CTIS users and clinical trial sites. EMA is offering this dedicated support to address issues and questions related to registering the organisation and/or location data in OMS for use in CTIS clinical trial applications.

The calendar of the sessions is shown below:

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

EUCROF is pleased to announce that the Lithuanian GCP & RA Association has become a new Full Member, taking the overall tally to 14! The Association’s mission is to promote continuous innovations in drug development in cooperation with national and international research organisations, thus developing progress oriented Lithuanian clinical research and regulatory practices that improve patients’ health and ensure wellbeing.

 Members of The Lithuanian GCP & RA Association are contract research organisations (CROs) and data science companies that represent and encourage advancement, innovation, and the continued progress in the pharmaceutical, biotechnology, and medical device industries. The Association presented at the Spring GA in Prague.

EUCROF is pleased to announce that OCT Clinical Trials based in Latvia has become an Associate Member. They also presented at the Prague GA. OCT Clinical is one of the leading mid-size contract research organisations (CROs) in Eastern Europe, with a portfolio of 300+ clinical trials in 29 therapeutic areas. The team of 200 clinical research professionals provides a full range of CRO services for phase I to IV and bioequivalence studies: medical writing, consultancy, project management/monitoring, data management/biostatistics and turnkey service for clinical development.

A warm EUCROF welcome to both the Lithuanian GCP & RA Association and OCT Clinical Trials.

Our second EUCROF webinar for the year 2022 took place on Wednesday, 13th July. Its title was “EMA Clinical Trials Information System (CTIS) CRO / Sponsor Organisation Models in CTIS” and was hugely successful with 96 attendees. The presenter was Marieke (M.A.) Meulemans, M.Sc. CEO and Founder GCP Central B.V.

Overview:

As of January 31st, 2022, all research on human subjects with medicinal products in the EU need to be submitted via the EMA Clinical Trial Information System, the CTIS. In the current transition period, organisations focus on the setup of the optimal organisation model in CTIS, which ensures a smooth collaboration between CROs and Sponsors and enables optimal use of the standardised timelines of EU CTR.

In this Webinar, Marieke Meulemans, who was supported by Dagmara Kolalowska (Deloitte) and Laura Fuentes (Apices CRO), and was introduced by Ana Moreno (Apices CRO), explored the possible organisation models and discussed different scenarios around this topic. An organisation-centric model with a Sponsor Admin overseeing assignment of Clinical Trial Admins seems to be the most logical execution model for most of the (big) CROs and Sponsors. What is the best organisation model for small and mid-sized CROs? How will access be granted to CROs? And what Organisation model to propose to your Sponsor in a multi-CRO model? The sponsor would probably want to restrict access, without impacting the collaboration. Attending this webinar makes you aware of the possible organisation models in CTIS and what scenarios CROs can propose to their clients.

This Webinar was the second of a series of Webinars EUCROF is offering to facilitate the understanding and future operational work with the CTR and the Clinical Trial Information System (CTIS).

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..

• The first 6 months of 2022 have 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 Stakeholders' Group meeting (EMA virtual) on 11 May 2022, where Dr Martine Dehlinger-Kremer and Dagmar Chase represented EUCROF.
  • 1st face to face Meeting AI/ML joint team (EUCROF and eClinical Forum) + eClinical Forum Workshop on 16 – 19 May 2022 in Brussels (BEL) where Sofoklis Kyriazakos (BeCRO), Alan Yeomans (ASCRO) and Lina Gaggi (ASCRO) represented EUCROF
  • First Big Data Steering Group and Industry Stakeholders meeting on 30 May 2022 (EMA virtual) where Bart Scheerder (ACRON), Alexandre Malouvier (AFCROs), Peter Binish (ASCRO) and Lyle Wiemerslage (ASCRO) represented EUCROF
  • Approach for assignment of MAH Admin role in CTIS (EMA virtual) on 3 June 2022 where Dagmar Chase represented EUCROF.
  • General Assembly of c4c on 14-15 June 2022 in Ghent (BEL) where Dr Martine Dehlinger-Kremer was in attendance.
  • First Industry Standing Group Meeting (EMA virtual) on 21 June 2022 where Dr Martine Dehlinger-Kremer and Simon Lee represented EUCROF
  • Enpr-EMA Coordinating Group meeting EMA (virtual meeting) on 30 June where Dr Martine Dehlinger-Kremer represented EUCROF
  • Clinical Trials Information System Stakeholders' Meeting (EMA virtual) on 8 July 2022 where Dagmar Chase, Simon Lee and Martine Dehlinger-Kremer represented EUCROF
  • Approach for assignment of MAH Admin role in CTIS (EMA virtual) on 13 July attended by Dagmar Chase
  • Workshop on Draft Guidance Protection of Personal Data and CCI in CTIS (EMA virtual) ON 14 July 2022 where Mihaela David (PSI CRO), Cari Jacobs-Blom (CR2O B.V.) and Tineke de Boer (ICON, NL) represented EUCROF

  
  

  Our thanks to all those who have represented EUCROF so far in 2022.

• • 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 organised an info session to stakeholders, which took place on 3rd February.  

  The Joint Action has been set up to implement the EU Strategy on COVID-19 therapeutics.

  It will be financed under EU4Health managed by HADEA.

  The Guidance Document issued by the EMA encourages all Member States to adopt the provisions. The most up to date information can be found here.

  
  

  • EMA communication: Updates on COVID-19 vaccines

   Recent communications on COVID-19 vaccines and treatments:

  • EMA adopts first list of critical medicines for COVID-19
  • Safety of COVID-19 vaccines
  • EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
  • EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
  • Start of rolling review for adapted Spikevax COVID-19 vaccine
  • Start of rolling review for adapted Comirnaty COVID-19 vaccine
  • Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic

  • EMA has endorsed a statement for healthcare professionals jointly developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). The statement is aimed to help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines and to reassure medical staff about the safety of COVID-19 vaccines that undergo a robust scientific evaluation to determine their quality, safety, and efficacy.

  • ​ EMA communication: International regulators and WHO: support healthcare professionals to enhance public confidence in COVID-19 vaccines

  ICMRA and WHO also highlighted the measures put in place nationally and globally to continuously monitor the safety of COVID-19 vaccines that are used in countries worldwide.

  “The COVID-19 vaccination campaigns have generated the largest set of information on vaccines, including real-world data from clinical practice, that we, the international community of regulators, have ever received,” said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. “The data clearly show you can trust the science – these vaccines work.”

  The statement also contains up-to-date information as well as questions and answers on:

  • clinical trial data (including effectiveness studies);
  • COVID-19 virus variants;
  • commonly reported adverse events for each vaccine type;
  • the latest advice on vaccine boosters and vaccine safety in children and pregnant women.

  ICMRA and WHO will continue to monitor data on COVID-19 vaccines and their safety and provide any updates as they become available.

  The development of the joint statement, which was last updated in January 2021, followed a series of discussions among ICMRA members and WHO on the importance of public confidence in COVID-19 vaccines. The ICMRA-WHO statement is available in English and French on the ICMRA and WHO websites.

  This news and related content are published here.

  
  

  • EMA communication: Global regulators agree on key principles on adapting vaccines to tackle virus variants

   On 30th June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop co-chaired by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The meeting focused on identifying key principles to support the adaptation of COVID-19 vaccines to better match Omicron variants of concern, and on ensuring global regulatory alignment.

  Participants from 18 members and the World Health Organization (WHO), including the vice-chair of the WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC), engaged in the scientific discussions.

  More details on this announcement and related content can be found here.

• • EMA publishes its annual report 2021

  Annual reports and work programmes published recently provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU) and highlights EMA’s most significant achievements.

  These include the Agency’s activities to tackle the COVID-19 pandemic but also its work related to the scientific assessment and supervision of medicines in the EU. The digital report features main outcomes regarding the evaluation and monitoring of human and veterinary medicines and the European medicines regulatory network’s response to COVID-19 and includes a selection of key figures. It also contains an interactive timeline of important milestones in 2021, allowing readers to explore each topic in more depth through additional documents, audio-visual materials, and infographics.

  
  

  • EMA’s interaction with industry - biennial report 2020-2021

  We are pleased to share with you the 2020-2021 biennial report of EMA’s interaction with industry.

  The report describes EMA’s interaction with industry stakeholders during 2020-2021, two years which were characterised by global and European challenges, as well as ambitious regulatory changes.

  2020 was marked by events which substantially impacted EMA’s role and priorities most notably, WHO’s declaration of the COVID-19 pandemic in March. This resulted in the scope modification and extension of EMA’s Business Continuity Planning, which was already in place to manage the challenges created by Brexit and was adapted to the new pandemic crisis situation (European Medicines Regulatory Network COVID-19 Business Continuity Plan).

  
  

  • Statement by EMA Executive Director Emer Cooke on why vaccines contribute to a “Long Life for All”.

  The European Immunization Week, which takes place every year between 24 and 30 April, was a great opportunity to remind ourselves how lucky we are to be living in a world where vaccines exist. We have vaccines against more than 20 life-threatening diseases, including polio, diphtheria, tetanus, whooping cough, COVID-19, influenza, and measles. It is estimated that these vaccines prevent between two and three million deaths every year worldwide.

  Thanks to vaccines, people of all ages, from all continents, already have the chance to live longer, healthier, and more fulfilling lives.

   Please click here for the full statement and to look at some facts.

  
  

  • EMA communication: EMA recommends approval of Imvanex for the prevention of monkeypox disease

   EMA’s human medicines committee (CHMP) has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults from monkeypox disease.

   The medicine has been approved in the EU since 2013 for the prevention of smallpox. It contains an attenuated (weakened) form of the vaccinia virus called ‘modified vaccinia virus Ankara’, which is related to the smallpox virus. It was also considered a potential vaccine for monkeypox because of the similarity between the monkeypox virus and the smallpox virus. The marketing authorisation holder is Bavarian Nordic A/S.

  For more details on this announcement and related content, please click here.

  
  

  • 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) studies 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 antibodies 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: First gene therapy to treat severe haemophilia A

  EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) for the treatment of severe haemophilia A in adults who do not have factor VIII inhibitors (auto-antibodies produced by the immune system which make factor VIII medicines less effective) and no antibodies to adeno-associated virus serotype 5 (AAV5).

  Patients with haemophilia A cannot produce factor VIII (an essential protein required for blood to clot and stop bleeding); they are more prone to bleeding and have prolonged bleeding, e.g. after injury or surgery. Haemophilia A is a rare debilitating disease affecting approximately 0.7 in 10,000 people in the EU. It is life long and may be life threatening when bleeding occurs in the brain, the spinal cord, or the gut.

  Medicines currently authorised for treating haemophilia A mostly contain factor VIII, to replace the missing protein. Available treatments require one or more injections per week or per month and are lifelong. Therefore, there is an unmet medical need for new therapeutic approaches that might free patients from frequent injections.   

  Roctavian is the first gene therapy to treat haemophilia A.

  Patients treated with Roctavian will be monitored for 15 years, to ensure the long-term efficacy and safety of this gene therapy.

  Roctavian was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs.

  This communication and related content have been published here.

  
  

  • EMA communication: Facilitating global access to diabetes treatments for non-EU patients

  EMA’s human medicines committee (CHMP) has given a recommendation for two diabetes mellitus treatments, Actrapid and Insulatard, for use outside the European Union (EU).

  EMA is committed to supporting global regulatory capacity building and contributing to the protection and promotion of public health beyond the EU by assessing medicines for countries with limited regulatory resources. The two diabetes medicines were submitted to EMA under a regulatory procedure (Article 58 of Regulation (EC) No 726/2004) known as EU Medicines for all (EU-M4All).

  This allows the Agency to assess the quality, safety and efficacy of medicines that address unmet medical needs or are of major public health interest for use outside the EU and give an opinion on their benefit-risk balance, considering the context of their use in target populations and any specific requirement in certain low- and middle-income countries outside the EU. Medicines submitted under this programme are assessed by EMA in collaboration with experts from the World Health Organization (WHO) and the target countries. Any medicine assessed under this procedure must meet the same standards as medicines intended for EU citizens.

  Actrapid and Insulatard are the thirteenth and fourteenth medicines to receive an EMA recommendation under EU Medicines for all (EU-M4All). Experts from the WHO and regulators from Bangladesh, India, Iraq and Zambia were invited to follow the evaluation as observers. This helps to ensure that specific disease expertise and local knowledge are taken into account.

  National regulators can use the CHMP's scientific assessment to decide on the use of these medicines in their countries.

  This news announcement and related content have been published here.

  
  

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

  We are pleased to send you our latest edition of the monthly Newsletter which includes decisions by our 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.

  
  

  • EMA communication: First therapy for AADC deficiency, Niemann-Pick and Progeria diseases

   The EMA has recommended granting a marketing authorisation in the European Union for:

  • First therapy to treat rare genetic nervous system disorder AADC deficiency

   First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder

  First treatment for children with Progeria or progeroid like syndromes (rare premature aging syndromes). For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

  
  

  • EMA communication: Synchron Research Service: suspension of medicines over flawed studies

  EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of several generic medicines tested by Synchron Research Services, a contract research organisation (CRO) located in Ahmedabad, India.

  The recommendation comes after irregularities were found in how the CRO carried out bioequivalence studies, which raised serious concerns about the company’s quality management system and the reliability of data from that site. Bioequivalence studies are conducted to show that a generic medicine releases the same amount of active substance in the body as the reference medicine.

  The list of concerned medicines can be found in the list of medicines concerned by the procedure.

  The CHMP's recommendation will now be sent to the European Commission which will issue a legally binding decision in due course.

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

  
  

  • Stakeholder survey - Patient involvement in Health Technology Assessment (HTA)

  The International Society for Health Technology Assessment (HTAi), the European Patients Forum (EPF) and the European Patients’ Academy on Therapeutic Innovation (EUPATI) are conducting a survey among HTA stakeholders (such as researchers, patients, industry, academics, administrators, payers, HTA practitioners) as part of research into patient involvement in HTA interactions.

   Please click here for the link to the survey and further information:

  
  

  • EMA communication: EMA guidance supports development of new antibiotics

   As part of its efforts to support a global approach to the development of new antimicrobial medicines, EMA has published the final revised guideline on the evaluation of human medicines for the treatment of bacterial infections.

  Antimicrobial resistance (AMR), which is the ability of microorganisms to resist antimicrobial treatments, especially antibiotics, has a direct impact on the health of people and animals and carries a heavy economic burden worldwide. In the European Union (EU) alone, it is responsible for an estimated 33,000 deaths per year. It is also estimated that AMR costs the EU €1.5 billion per year in healthcare costs and productivity losses.

  EMA plays an important role in the fight against AMR by guiding and supporting the development of new medicines and treatment approaches, especially for patients with infections caused by multidrug-resistant bacteria, who currently have very few therapeutic options.

  The revised guideline is published together with an addendum aiming to steer clinical development programmes required to support the authorisation of medicines for treatment of bacterial infections in children.

  For the treatment of some infections, efficacy results can be extrapolated in certain children age groups by looking at efficacy data from adults. The addendum mentions that companies developing new antibiotics need to develop an extrapolation concept and provide details about it in an extrapolation plan.

  For some infections that occur only or mostly in children below a certain age, extrapolating efficacy data from adults is not possible. The addendum includes guidance on trials that may be conducted in these exceptional cases.

  The revised guideline was under public consultation for six months in 2019. The final document with all the updates implemented was adopted by EMA’s human medicines committee (CHMP) at its May 2022 meeting.

  This news and related content have been published here.

    

  • EMA Communication - Big Data Steering Group adopts final list of metadata for describing real-world data sources and studies

  In line with the EMRN Strategy to 2025 action on data discoverability, the Big Data Steering Group (BDSG) has a adopted a final list of metadata for describing real-world data (RWD) sources and studies.

  The metadata list was produced following extensive consultation via webinars and gathering feedback through surveys from various stakeholders including the industry, international regulators and EUNDB.

  The metadata will be included in an EU catalogue of data sources, to replace the current ENCePP catalogue and a catalogue of observational studies to replace the current EU PAS Register.

  Setting up a catalogue of data sources and a catalogue of studies aims to deliver enhanced transparency with regard to observational studies, enhanced discoverability of studies and data sources and contribute to increasing the ability to judge the evidentiary value of observational studies and real-world data sources when used to investigate the use, safety, and effectiveness of medicinal products.

  The catalogues will also promote the use of the FAIR principles (Findable, Accessible, Interoperable and Reusable) for data.

  Increasing data discoverability through the development on the metadata list and the establishment of a data quality framework will help signpost regulators, researchers, and industry to the relevant data sources to address a research question.

  Increased discoverability will ultimately improve the evidence available to assess the benefits and risks of medicines and facilitate getting better medicines to patients.

   Should you have any questions please contact the BDSG secretariat at This email address is being protected from spambots. You need JavaScript enabled to view it..

  
  

  • Call for Funding Task Force

  As discussed in the GA in June, EUCROF would want to apply for fundings 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 September 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.