eNews April 2021

Dear Members, Associate Members, Partners and All,

Together with the EUCROF Board, I am very happy to present our second EUCROF Newsletter of 2021. The Newsletter sets out to review activities since the start of the year and looks ahead at what is planned in the coming months. Even though we continue to be faced with a global pandemic with COVID-19 and its resultant challenges, EUCROF and its representatives continue to be active in many initiatives internally and with external stakeholders and groups. I hope that with the vaccine roll out starting to gather momentum across Europe and globally we can all start to feel safer and transition back to some form of normality both with our families and at work. The sector we work in will continue to play a significant part in helping us to all achieve this in the months ahead. 

I am pleased to highlight the increasingly positive activity associated with EUCROF’s Code of Conduct for the General Data Protection Regulation. After many years of hard work by the New Technologies Working Group led by EUCROF’s Executive Board member, Yoani Matsakis, the Code has been submitted for review to the relevant authorities and we are beginning to develop the plans to promote it to the broader industry and also to establish the required Monitoring Body ahead of its ultimate implementation. My thanks to all of my EUCROF colleagues involved in progressing this important initiative. 

You may have already heard that the EMA’s Clinical Trial Information System (CTIS) has successfully passed it independent audit and the EMA has subsequently announced this new IT system is now fully functional and on track to go live by 31 January 2022. EUCROF representatives continue to be heavily involved in the development of the system and establishing the necessary training packages to ensure its effective use by the industry post launch. To this end last month, we held our most successful webinar on this topic with over 190 registrants just confirming even more than ever the importance of being ready for next January! My thanks to all those who represent EUCROF in this work.

We are looking forward to EUCROF’s Spring General Assembly in June. Once again due to the restrictions associated with the COVID-19 pandemic, it will be a virtual meeting. However, it will still be a great opportunity for all EUCROF members and partners to meet and discuss progress and the future plans for each of our many initiatives.

Now, with less than one year to go, preparations for the next EUCROF Conference on Clinical Research in Madrid 2022 are gathering pace with each of the Committees increasing their activities related to developing the programme, the organisation, and communications for the Conference. As always, your involvement and participation in this Conference will be so important to its ultimate success.

Finally, I would like to personally thank everyone for their continued efforts and contributions to the success of EUCROF.

Good health and stay safe in the coming weeks and months. 


Dr Martine Dehlinger-Kremer

EUCROF President

EUCROF’S New Technologies Working Group has been developing the Code of Conduct for several years. In recent times, it has achieved a number of important milestones. For example, in March EUCROF issued a press release, announcing the submission for approval of the EUCROF GDPR Code of Conduct to the relevant Data Protection Authorities. This press release was published on the EUCROF website in the Latest News section (Latest News (eucrof.eu)). If interested, you can also find the link to "More about the EUCROF Code: download the full presentation note".

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 support and involvement.

A Promotion 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 within the industry.

Look out on EUCROF’s website for future updates on the important initiative.

Finally, European data protection board to strengthen sharing of health data between EU and UK.

For more information, CLICK HERE.

The New Technologies Working Group has recently developed and issued an eConsent Implementation Guide.

This is a significant step in an important area in clinical research and our thanks to the team for developing the guide.  To read the guide please CLICK HERE.

Also, the Guide was presented in a EUCROF webinar, the recording of which is still available in the Moodle platform. For more information please contact Assia Rosati via This email address is being protected from spambots. You need JavaScript enabled to view it..

These continue to be unprecedented times with the global outbreak of COVID-19 impacting all aspects of society and businesses. Given the widespread impact across Europe, undoubtedly all of EUCROF’s members will have been affected in some way over the last year. Throughout this time, EUCROF has continued to try to assist its members as follows: -

  • EUCROF supports COVID-19 Vaccine Distribution Access for Clinical Research Professionals - A letter for your respective National Health Authorities

The COVID-19 pandemic has a significant impact on our business and the continuation of clinical trials.

Now, with the approval of the first COVID-19 vaccines and commencement of their roll out, it is vitally important that we secure the role Clinical Research professionals play in clinical studies, not just those relating to COVID-19, but also critical research into other diseases and into life-threatening ones.

Communications with some of you and the clinical research sites, have highlighted a need to request that all those personnel directly involved in delivering clinical studies, at our hospitals and research centres, be considered the same as health care workers, in order to give them the same priority in the vaccination plans across each country.  This includes clinical staff, but also those staff in CROs such as CRAs who play a vital role in ensuring clinical studies are delivered in accordance with ICH GCP.

EUCROF and the global Society for Clinical Research Sites (SCRS) have prepared a letter for your respective National Health Authorities to request that your staff involved in clinical trials at sites get the possibility to be vaccinated with the first prioritised persons. Please submit the letter in your respective country to the relevant Health Authorities.

A copy of the letter was sent to the EMA (Emer Cooke, EMA Executive Director & Fergus Sweeney, Head of Clinical Studies, as well as to the European Commission (Stella Kyriakides, Commissioner Health & Food Safety), for them to be aware and support the request.

For those you do not know SCRS, it represents 10,000 research sites worldwide and serves as the unifying voice of the clinical research site community (https://myscrs.org).

Should you have any question, or need any further support, please do not hesitate to contact

EUCROF’s Secretariat at any time (This email address is being protected from spambots. You need JavaScript enabled to view it.).  

  • EUCROF Website

In order to help support our members during these challenging and difficult times, a specific section for COVID-19 pandemic has been set up on our website, which provides information on new guidance in Europe (EMA and further authorities (27 MS, UK), and US (https://www.eucrof.eu/legislations-and-regulations). We hope you are continuing to find this useful.

  • EMA Guidance on Covid-19

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


  • EMA communication: Updates on COVID-19 vaccines

 The EMA’s most recent communications on COVID-19 vaccines are as follows:

  • COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
  • 02 Public Safety Update_COVID-19 VACCINE JANSSEN_22 April 2021
  • COVID-19 Vaccine Janssen DHPC: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
  • EMA starts review of VIR-7831 for treating patients with COVID-19
  • AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets
  • AstraZeneca’s COVID-19 vaccine: benefits and risks in context
  • EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe

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

  • EMA communication: EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials

EMA has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials.

For more information CLICK HERE

  • Conduct of Clinical Trials of Medical Products during the COVID-19 Public Health Emergency

The updated FDA guidance on the Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency (version dated 27 January 2021). Click Here for more information.

The webinar programme organised by EUCROF’s Events & Training Working Group have continued to be highly successful since the start of 2021, riding on the back of a highly productive 2020. There was one webinar held so far this year, which turned out to be the most successful ever in terms of number of registrants.


As of January 2022, all scientific research with medicinal products in the EU need to be submitted via the Clinical Trial Information System, the CTIS. To make sure all future users of the CTIS system, both sponsors and member states, are familiar with the settings and way-of-working in the system, the EMA has setup a training programme - consisting of both free e-learning material and a Master Trainer Programme, instructing the company’s trainers to support implementation and use of the system. In this webinar, Marieke Meulemans showed what training material has been created, where to find it and supports your preparation in the use of the CTIS with useful tips and considerations. Attending this webinar makes you aware of the steps to take in the next 9 months to get ready.

Also, the recording of the webinar is available in the Moodle platform if they would like to enrol. For more information please contact Assia Rosati via This email address is being protected from spambots. You need JavaScript enabled to view it..

Despite the ongoing challenges presented by the COVID-19 pandemic, the start of 2021 has been busy with colleagues representing EUCROF at multiple meetings across a number of topics. Our thanks to all those who have represented EUCROF during the last few months.

  • Enpr-EMA Coordinating Group Meeting - Conference Call Meeting attended by EUCROF’s President Martine Dehlinger-Kremer on 2 March 2021
  • Technical workshop on real-world metadata for regulatory purposes – a virtual meeting attended by Sofoklis Kyriazakos and Alexandre Malouvier on 12 April 2021
  • Paediatrics Clinical Research Workshop organised by EU Commission, IMI and & paediatric clinical research networks. Aim was to prepare for revision of the Paediatric Medicines Regulation, the Horizon Europe programme. This virtual meeting was attended by Dr Martine Dehlinger-Kremer on 14 April 2021
  • SCRS European Site Solutions Summit on 20-22 April 2021– attended by Dr Martine Dehlinger-Kremer who presented “Clinical Trial Sites: Key Contributors to Optimal Pediatric Drug Developments”

CTIS meeting with EMA – a virtual meeting attended by Dr Martine Dehlinger-Kremer, Dagmar Chase, and Simon Lee on 23 April 2021

  • As you may be aware from previous Newsletters, the EU Clinical Trial Information System (CTIS) entered its planned audit in December 2020, after a very busy year of development by the EMA team and industry stakeholders, including representatives of EUCROF. The outcome was always going to determine whether the system is ready to enter the final stages of development ahead of its implementation in 2021/2022.

    On 21 April 2021, Fergus Sweeney, Head, Clinical Studies and Manufacturing at the European Medicines Agency, announced that the EMA Management Board during its extraordinary meeting confirmed that it had verified that the clinical trial EU Portal and Database (CTIS) had met the agreed requirements, following an independent audit of the IT system and that it was now fully functional and on track to go live by 31 January 2022. This is an important milestone for the CTIS and now it continues with the final phases of the systems development in the coming months.

    For further details, please see the news published on the EMA’s website, link: https://www.ema.europa.eu/en/news/clinical-trials-information-system-reaches-major-milestone-towards-go-live-application-clinical.

    The CTIS high level training programme continued to be progressed with EUCROF very much at the forefront of the ongoing work. To this end, Marieke Meulemans (from GCP Central, a member of ACRON) continues to lead activities representing EUCROF and also all the industry associations ACRO, EUCOPE, EuropaBio, EFPIA, and VE. Our continued thanks to Marieke for undertaking this role and continuing the hard work and giving time required.

    The programme is organised in batches, each encompassing several modules (ca. 20) with the last batch of training materials expected to be delivered by June 2021 in order to be ready for the 'Go Live', which is currently anticipated to be from July 2021 onwards, subject to the outcome of the audit and final confirmation of a definitive implementation date by the EMA.

    A summary of the Modules developed:

    Module 1: Introduction to Clinical Trials Regulations

    Module 2: Overview of main CTIS components and common system functionalities

    Module 3: User Access Management (self-registration, login, and user profile)

    Module 4: Support with workload management by workspace

    Module 5: How to manage a CT

    Module 6: How to evaluate a CT application (Validation)

    Module 7: Management of registered users & role matrix

    Module 8: How to evaluate an Initial Clinical Trial Application: Assessment and Decision

    Module 9: How to search, view and download a CT in the sponsor workspace.

    Module 10: How a Clinical Trial Application should be added to the CTIS and explains other application types such as adding a Member State and Substantial Modifications.

    Module 11: RFIs (new!)

    Module 12: Clinical Study Reports

    Module 13: Supervise a CT (MS)

    Module 14: MS Search, view and download a CT (MS)

    Following is an update on the achievements made in the CTIS eLearning development in the last month (March - April 2021):

    • The final 2 modules of Batch 3 have been evaluated by the CTIS Training Expert Group on Monday April 12. The contents of Batch 3 were modules 11 to 14:

    The quality of the modules was high, although there are some content updates required for both Module 13, which is essential to Sponsors: The module about the CSR may need reference to the Summary report as well, although this topic has been included in Module 5 as well.

    With the evaluation meeting, batch 3 of development has been finalized in time. The CTIS Training catalogue is now 61% complete.

    • Training materials of modules 1 to 12 are available for the users via the public EMA website. Module 13 and 14 will be added shortly.
    • Additionally, in Batch 3 the following actions were setup/completed:
      • o A List of acronyms has been created, including the acronyms used in the training materials and their definitions
      • o We endorsed the creation of a digital FAQ about the topics of all modules instead of having FAQs per module, as 1 central, searchable FAQ would be more end-user friendly. The EMA will look into this request.
      • o The way of working with Learning Goals / Objectives has been evaluated. There are still some inconsistencies that could be addressed to improve the user's learning experience. A well-written learning objective outlines the knowledge, skills and/or attitude the learners will gain from the educational activity and does so in a measurable way. I will work with the CT Training team to support improvement of the learning goals and ensure alignment with our members' needs.
    • Batch 4 development is planned for April to June 2021. All modules below in Batch 4 are addressed at the target audience Member States. No Sponsor modules will be developed in this batch, though the Sponsor representatives will be involved in the evaluation of the Modules. After finalisation of this batch, the EMA CTIS Training catalogue will be 78% complete.
      • o Module 15 - MS Search, view & download a CT/CTA
      • o Module 16 - Supervise a CT - Inspection records
      • o Module 17 - Supervise a CT - Ad hoc assessment
      • o Module 18 - Create and submit an ASR
    Please remember to find the online training modules here: s/clinical-trial-regulation/clinical-trials-information-system-ctis-training-programme. If you have any questions, please contact 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.
  • EMA communication: "Human Medicines Highlights" Newsletter – February 2021 issue

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

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

  • EMA consultation: Draft toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME (priority medicines) marketing authorisation applications

The European Medicines Agency has published for public consultation a draft toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications.

The EMA launched the PRIME scheme to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.

Experience to date has shown that applicants face challenges to complete quality and manufacturing development and data requirements during development of medicines for early access. This document provides guidance, in a ‘toolbox approach’, by summarising scientific elements and regulatory tools, available in the existing EU regulatory framework, that can be applied to support the development and completion of Module 3 quality data packages in the preparation of marketing authorisation applications of designated PRIME medicinal products.

The scope of this document is on medicinal products that have received PRIME designation by the Committee for Medicinal Products for Human Use and includes medicinal products containing chemical, biological and/or biotechnologically derived substances and Advanced Therapy Medicinal Products.

It is recognized that some of the tools described in this document may be considered on a case by case basis, and prior to agreement with regulators, for other products intended for early access that address an unmet medical need.

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 July 2021.

  • EMA consultation: Guideline on good pharmacovigilance practices on risk minimisation measures (Rev 3) and addendum II on methods for effectiveness evaluation

The European Medicines Agency has published for public consultation two different modules, both part of the Guideline on Good Pharmacovigilance Practices (GVP).

  • Guideline on good pharmacovigilance practices (GVP) - Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)

Revision 3 includes, among other updates, the clarification of the role of risk minimisation for risk management planning and for the impact on the risk-benefit balance of medicinal products, and the role of effectiveness evaluation of risk minimisation measures, and to delete/merge. It also gives more guidance about the criteria for applying/requesting additional risk minimisation measures; to give more details on the role of healthcare professionals and patients and to clarify possible strategies for their early engagement and role in risk minimisation development, dissemination and evaluation.

  • Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum II – Methods for effectiveness evaluation

This Addendum to GVP Module XVI provides additional guidance for marketing authorisation holders and competent authorities on data sources and methodologies for monitoring outcomes of risk minimisation measures (RMM) in line with the principles for RMM effectiveness evaluation laid down in GVP Module XVI. Depending on the risk minimisation objective, studies evaluating RMM effectiveness may integrate different quantitative measurements and qualitative research approaches to evaluate risk minimisation outcomes for individual tools or sets of RMM described in GVP Module XVI.

For more details, please click here.

  • Guidance for Paediatric Clinical Trials with Medicinal Products in Europe

The EMA published the document for Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe as Developed by Enpr-EMA’s Working Group on Ethics.


  • EMA Consultation:  Call for scientific data for 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 eight herbal monographs 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.

Deadline for comments: 30 June 2021. 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.

We are pleased to inform you that EUCROF, together with the eClinical Forum, have now published the Archiving Position Paper on their respective websites. See the following links:


Latest News - https://www.eucrof.eu/news-eucrof/latest-news/02-03-archiving-position-paper  

Publications - https://www.eucrof.eu/publications  

The paper itself - https://www.eucrof.eu/images/21_02_24_Archiving_Position_Paper_version_A.pdf

eClinical Forum

News - https://eclinicalforum.org/en-us

Publication - https://eclinicalforum.org/en-us/Download

The paper itself - https://eclinicalforum.org/DesktopModules/EasyDNNNews/DocumentDownload.ashx?portalid=0&moduleid=454&articleid=166&documentid=84&localeCode=en-US  

EUCROF has also published a news about the release on LinkedIn –


We would be happy if you could spread the information to your organisations and contacts.

Medical Devices Regulations will be one of the hot topics for 2021 and beyond.

As MDR will be effective by 26 May 2021, we would like to enhance our activities on that topic.

As a first step, we wish to enlarge the number of the Medical Devices Working Group Team Members.

EUCROF would like to invite whoever is interested in this WG to reach out to Şebnem Yaşaroğulları (This email address is being protected from spambots. You need JavaScript enabled to view it.) and/or Antoinette van Dijk (This email address is being protected from spambots. You need JavaScript enabled to view it.) as Chair/Co-chair as soon as possible in May.

Progress is being made with this research project with the goal of mapping the CRO landscape in Europe. The project lead is Gert-Jan Dossche, a pharmacist and currently undertaking an additional master’s in business economics, plus following the ECCRT Junior Clinical Researcher star programme.

Contact points and deputies have been obtained from 20 of our Members, Associate Members and Partners and the plan is to start preparing in the coming months with the project commencing in April and running through to June. 

 Details of the role being undertaken are as follows: -

  • Undertake research project, including a survey and analysis of the financial balances of the CRO companies to benchmark the CRO landscape in Europe. This could potentially form part of a master’s qualification.
  • Develop the survey, including timelines, under the instruction of the Executive Board or a delegated thereof.
  • Liaise with EUCROF Members to issue the survey for completion by their members and other CROs that are located in their respective countries.
  • Liaise with EUCROF Members in the countries to coordinate the collection of the financial balance sheets of the companies in a harmonised way.
  • Collate the data and prepare a draft report for review by the EUCROF Executive Board.
  • Present the final report to the EUCROF Members at a General Assembly.
  • Identify opportunities to publish the report in an appropriate journal.

Watch out for further updates in future Newsletters and EUCROF’s website. In the meantime, any queries should be sent to Assia Rosati at This email address is being protected from spambots. You need JavaScript enabled to view it..

As previously reported, EUCROF Affiliates suggested the setup of a repository of individual CRO companies and the proposed initiative was discussed and approved at the General Assembly in December 2019. Subsequently, the Platform has now been developed and Member companies have populated it with their details, enabling its launch in July 2020.

Since then over 260 companies out of the 385 affiliated member CROs are identified on the platform, but many more could be created with the support of our Member Associations. Already the CRO platform has triggered some requests for information from visitors, which is great news. Even so, this can be enhanced as too few companies on the CRO platform are still to fully complete their profiles, which reduces their chances of generating some business interest. Actions will be taken by the Communications WG to trigger the better completion of individual company profiles.

Overall, this is an exciting initiative which we believe will be beneficial to all those companies associated with EUCROF.  We wish to thank Christophe Golenvaux, chair of the Communication WG, who is leading this initiative.

Further update will be provided in the next Newsletter. In the meantime, contact 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. 

Due to the continued COVID-19 restrictions in place across Europe, the decision has been taken to hold the Spring General Assembly remotely, via GoToWebinar once again. The GA will take place on Thursday 3rd June to Friday 4th June. As always, this will be an important meeting to evaluate the status of current initiatives and agree future initiatives for the remainder of the year for the EUCROF team.

More information will be sent to all our Member Associations in May, but in the meantime, if you have any questions, please contact Assia Rosati via email on This email address is being protected from spambots. You need JavaScript enabled to view it..

The EUCROF next Conference will be in Madrid in February 2022 and planning has already commenced and is making good progress.

We have also established three committees to make the Conference happen and be a success. These are the Programme, Organising and Communications Committees. However, if there are still some volunteers who wish to join any of these Committees, they are still welcome to apply.

So, if you are interested and want to find out more, please do contact via email This email address is being protected from spambots. You need JavaScript enabled to view it..

Note - when applying, please keep in mind the following:

  • What matters above all, is the success of the Conference
  • Participation to the Committees means that the candidate commits to actively contribute to the activities of the related Committee.

Please see the link below to start promoting our Conference in Madrid in Feb 2022, by showing a video on our Conference in Amsterdam last February.

Please “like” and “share” with your LinkedIn account in order to widely distribute the information.


Thank you in advance for your support to the Conference!

The Events and Training Working Group has been busy finalising another exciting programme of webinars and Podcasts for 2021.

The next webinar planned is entitled ‘Staying Safe on the Way to Innovative Therapeutic Options - Phase I Trials in Research Clinics’. It is scheduled to take place on 17 May 2021 from 3:00 PM to 4:30 PM (CEST)

Overview:  In the light of a global pandemic, clinical research in early-stage development reached a new degree of interest as the world relies on scientists to find solutions for unmet medical needs. Under the pressure of this scenario all parties involved in clinical research have to re-organise the working floor and find to ensure the utmost safety of trial participants while in parallel improve the productivity and speed.

In drug development, the most sensitive part is the switch from non-clinical to clinical conduct, namely the First-in-Human/First-in-Patient (FIH/FIP) Phase I clinical trials.

To ensure utmost safety, a trial specific risk analysis and risk-minimizing measures are required for trial design and protocol, as well as for the translation into practical conduct for executing infrastructures in specialized Phase I research clinics.

The basic principles of safety arrangements in clinical trials are regulated by international guidelines and local laws and requirements. For the EU countries the Clinical Trials Regulation 536/2014 based on ICH GCP E6 is implemented as binding law for the conduct of clinical trials.

Since this law does not distinguish between the different phases of drug development starting with FIH/FIP Phase I up to confirmatory Phase III trials, the EMA took action in 2017 to update the guideline for FIH/FIP clinical trials which states that “the early clinical development of human medicinal products has an intrinsic element of uncertainty in relation to both the possible benefits and risks of a novel drug candidate”.

This webinar will help to understand more about the risks and benefits of early-stage clinical trials conducted in specialized Phase I research clinics. It will highlight the points to be considered for planning and conduct of Phase I trials:

  • safety management plan
  • adequate personal resources
  • adequate locations/wards
  • adequate technical equipment
  • processes for management of emergencies
  • adequate conditions for PK sample, collection, handling, and processing.

The presenters are Dr Angela Bischoff, Director Clinical Operations, and Dr Eugenia Prohin, MsC, Manager International Clinical Operations, ARENSIA Exploratory Medicine.

Attendance Fee:

€ 90, - for non-EUCROF members

€ 60, - for EUCROF members.

The second webinar scheduled for May is entitled “GDPR and Clinical Trials: Compliance and Harmonization” and will take place on 25 May 2021 from 10:00 AM to 11:30 AM (CEST).

Overview: The GDPR (General Data Protection Regulation) has been with us for three years now. Yet, the industry continues to struggle through the multiple legal interpretations of how the GDPR requirements apply to the clinical research. Ethics committees, data protection officers of the clinical sites and of study funding sponsors, as well as the other stakeholders, defend their approaches. This altogether expands the gap in how a CRO and therefore, a Sponsor should process personal data to state with confidence, “We are GDPR compliant”.

To enable mutual agreement on the rules of applying the GDPR requirements to clinical research and help CROs demonstrate compliance with the GDPR, the EUCROF task force initiated, developed and now is proud to introduce the first Code of Conduct in the industry. The Code is aimed to explain the application of the GDPR to the services delivered by the CROs.

If you are a data protection officer, you work in a regulatory or legal department, if you are a healthcare professional wishing to boost your awareness about protection of personal data in the trial-related domain and get some insightful tips, you are welcomed to join us on this webinar!

25 May 2021, on the day of the 3rd anniversary of the GDPR, we will guide you through the first clinical trial Code of Conduct. You will have the opportunity to ask questions about the Code and our reasons to trust in its value, as well as receive practical advice on adherence.

The presenters are Kate Smirnova, Data Protection Officer (DPO), PSI CRO, Victoria Watts, Vice President, Privacy and Global Data Protection Officer, Premier Research and Thierry Lepoutre, Manager Clinical Operations, Telemedicine Technologies.

Attendance Fee:

€ 90, - for non-EUCROF members

€ 60, - for EUCROF members.

Further webinars will be scheduled in the forthcoming year covering topics such as Regulation 536/2014 implementation, archiving of data and metadata from computerised systems, Focus on Patients, Clinical trials & new technologies/telemedicine (wearables, AI, etc)

So, there is a lot to look forward to in 2021. Keep looking at our website for future updates (https://www.eucrof.eu/webinars). Further details will be issued in the coming weeks, so look out for the email from This email address is being protected from spambots. You need JavaScript enabled to view it..

We expect to continue to be invited to represent EUCROF at major events and meetings across Europe in the coming year. So far, the following have been confirmed.

  • Face to Face Paediatric Training - “Essentials of Paediatric Clinical Research: What you need to know when preparing, conducting and monitoring paediatric clinical trials” - Munich (Germany) in October 2021 (subject to status of COVID-19 Restrictions) to be attended by members of EUCROF’s Paediatric Working Group.
  • Face to Face Personalised Medicines training, November 2021.