Dear Members, Associate Members, Partners and All,
Together with the EUCROF Board, I am very happy to present our fourth EUCROF Newsletter of 2021, reviewing activities since July 2021 and looking ahead at what is planned in the coming months. Since our last Newsletter, the last months have been very rich in activities and initiatives, despite the continued challenges we all face with the COVID-19 pandemic.
The first topic I wish to highlight to you all is our 6th European Conference on Clinical Research to be held in Madrid on 7 and 8 February 2022. Registration is now open. The programme for “Clinical Research in a New Era”, as always, is very strong, covering important hot topics and with excellent and well-recognised speakers from the authorities, pharma/ biotech, Ethic Committees, and patient representatives. Your involvement and participation in this Conference will be so important to its ultimate success. Please consult the information about how to register and participate, as well as become a sponsor and advertise your company at this Conference. We are looking forward to meeting you there.
I am so pleased to see that our webinars have continued to be a success with an average of 50 attendees participating to each one organised so far, on important topics such as Decentralised Clinical Trials, Trial Master File Archiving, Navigating Complexities to Increase Investigator Satisfaction, and the Decommissioning of Computerised Systems. My thanks to the speakers, the Events & Training Working Group team and to you all for your increasing interest in these valuable training opportunities.
Also, I am pleased to inform you that ASCRO, the Swedish CRO national association have re-joined the EUCROF family as a Full Member. A warm welcome back to our Scandinavian colleagues and congratulations on their 10th anniversary as an association!
I continue to be pleased by the progress being made with the establishment of the EUCROF Code of Conduct for the EU General Data Protection Regulation. The New Technologies Working Group Task Force continues to work with the relevant authorities and is taking the first steps in forming the required Monitoring Body ahead of its ultimate implementation in 2022. My thanks to all of my EUCROF colleagues involved in progressing this important initiative.
EUCROF continues to extensively collaborate with the EMA on the development of its Clinical Trial Information System (CTIS). With the Go Live date of 31 January 2022, in conjunction with the EU Clinical Trial Regulation, the next few months will be vital in completing the final steps of development and preparations of the necessary training packages to ensure its effective use by the industry post launch. My thanks to all those who represent EUCROF in this important work.
A new area where EUCROF is taking a keen interest is in the increasing demand for CRAs and other industry related roles, which our CRO members and the industry as a whole are finding very difficult to meet. Talking to many colleagues, this seems to be an issue impacting across Europe and even worldwide and EUCROF has set up a new task force to investigate ways in which EUCROF can help, for example, supporting training and development initiatives. This will be a long-term programme of work but it is key that we start to take action now, so look out for more on this important area in future newsletters.
Finally, the General Assembly on 2nd and 3rd December will soon be upon us all and I, together with my fellow Executive Board Members, very much look forward to meeting many of you in Munich for 2 days of discussion and debate. My thanks to our German colleagues of BVMA for organising the event and making all of the arrangements for what will be our first face to face meeting for 2 years, due to the restrictions of the COVID-19 pandemic.
EUCROF’s influence is growing across many aspects of Clinical Research and thank you in advance for your continued contribution to our success.
I wish you a healthy and successful end to 2021!
Dr Martine Dehlinger-Kremer
EUCROF President
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. The Code is currently in co-review phase and comments have been received from the 2 DPAs (Belgium and the Land of Bavaria in Germany) and all the rework that needs to be done will soon be accomplished by the Task Force. The lead DPA, CNIL, agreed that the revised Code (considering the comments resulting from the co-review phase) was ready to be distributed to all 27 EU Member States’ DPA for review during the remainder of 2021 and early 2022. This distribution took place on 19 October and the Cooperation phase has therefore started. The whole process should be completed by March 2022.
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 to members, to increase awareness and understanding ahead of launch, are scheduled for the coming months. The CRO Platform is being updated and, at the end of October, the companies wishing to adhere to the Code may start the adherence process.
Consult EUCROF website for future updates on the important initiative.
The New Technologies Working Group has recently developed and issued an eConsent Implementation Guide.
We are pleased to inform you that the “eConsent Implementation Guide developed and published by EUCROF and eClinical Forum earlier this year has been recognised by TOPRA and is a finalist at this year’s TOPRA Awards within the Innovation Category. This is really a great achievement. Congratulations to all those who contributed to the paper. The Award Ceremony will take place in London on November 18th, 2021 We are also pleased to inform you that the “eConsent” Podcast has been published on our website (https://www.eucrof.eu/news-eucrof/latest-news/03-09-eucrof-podcast-n-3-econsent).
In addition, EUCROF was invited to present at the EMA/GCP IWG workshop on AI in Clinical Research. A big thank you to Fiona for her great presentation.
Please consult the EUCROF website for more details (https://www.eucrof.eu/news-eucrof/latest-news).
There 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 the EUCROF 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.
With the approval of the first COVID-19 vaccines and commencement of their roll out, it was vitally important that we secured 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 EUCROF affiliated members 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 the respective National Health Authorities to request that staff involved in clinical trials at sites get the possibility to be vaccinated with the first prioritised persons.
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 of you who 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 the challenging and difficult times during the pandemic, a specific section for COVID-19 pandemic was set up on EUCROF 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:
- Safety updates of COVID-19 vaccines
- EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG
- EMA starts rolling review of Evusheld (tixagevimab and cilgavimab) developed for the prevention of COVID-19 in adults
- EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
- EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19 | European Medicines Agency (europa.eu)
Please check EMA’s dedicated webpage on COVID-19 for the latest updates.
All the latest updates on COVID-19 vaccines and treatments are available by clicking here.
The webinar programme organised by EUCROF’s Events & Training Working Group has continued to be highly successful in 2021 so far, continuing the trend of a highly productive 2021.
The fifth webinar held this year on 31 August 2021 was titled "The Home Care Services - Useful Tool for Decentralised Clinical Trials" The presenters was be Dr Cristina Florescu Moraid, MD, MSc, CEO Avantyo Institute of Clinical Research and Dr Janusz Kabata, MD, PhD, MBA, CEO GP4Research. Although this covered quite a niche topic, we had 21 participants, which is very good.
Overview
Clinical trials are research studies that use a group of participants to test health-related treatments or interventions. Historically, those studies have occurred mostly in centralised settings. This means that clinical trial visits involved the participant going to where the study principal investigators were practicing their regular duties, i.e. in clinics, hospitals, or physician offices. Sometimes, some patients travelled long distances to participate in a clinical trial. But as society in general is adapting to online interactions and home-based services, research studies are implementing new ways of engaging patients through telemedicine and home visits. In light of the COVID-19 emergency, home health providers have been presented with the chance to participate in such research. Decentralised clinical trials have been on the rise even before the pandemic of COVID-19. In many cases of ongoing hybrid trials, patients have been receiving medication at home as an emergency solution. The result? They like it and are now reaching out to the clinical trials sponsors asking for continued supply at their home. Home health visits enhance clinical trial participation and retention, which leads to the more rapid collection of data necessary for the drug development.
During this webinar questions regarding what specific opportunities exist to deliver home care services in clinical trials or why does HHC services make sense for clinical trials were answered and many more. We believe that the future of clinical trials will be decentralised, with home-based care providers set to play an important role in making it all possible.
Our sixth webinar for the year 2021 took place on 5 October. It was titled “Future of Clinical Trials: Navigating Complexities to Increase Investigator Satisfaction”. The presenters were Kelly Frend, Specialty Services Manager, WEMEA, World Courier and Stewart Black. There were 11 attendees on this occasion.
Overview
Since the outbreak of COVID-19, clinical trials have become even more complex and competitive. In order to ensure success and meet patient enrolment targets, sponsors not only need to attract the best investigator sites, but also need to focus firmly on the patient through new ways of working, such as utilising new routes and adjusting study protocols, including a rise in demand for direct-to-patient delivery.
This webinar on the future of clinical trials gave attendees the tools to navigate complexities while increasing investigator satisfaction.
Starting with an analysis of how the shift to decentralised trials enhances investigator’s accountability, it examined how to ensure your approach brings the needed support to investigators to enrol and retain patients.
The session covered how to reduce trial costs while improving quality and compliance, highlighting what are the sponsors’ requirements and what really matters to investigators.
Some of the topics addressed during the webinar included:
- Principal Investigators’ responsibilities in a decentralised trial
- Ensuring investigator oversight, drug integrity and protocol compliance from the patient’s home
- Boosting recruitment and retention for better clinical trials
- The cost of incidents
- What matters to investigators and sponsors?
- A new era of collaboration and innovation – how to keep investigators happy – case study
Our seventh webinar for the year 2021 took place on Wednesday, the 20 October titled “Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials”.
The presenters were Dr Dagmar Chase, GCP Consultant and Trainer, Clinrex Munich (Germany) and Alan Yeomans, Regulatory Affairs Manager, Viedoc Technologies AB. There were 40 participants which is excellent.
Overview
The archiving of clinical trial records is a required process that is in need of future direction to meet current business models as well as regulatory and legal expectations. A group of industry experts coalesced under EUCROF and the eClinical Forum to formulate a position paper discussing the needs and proposed practical directions for archiving of clinical research.
The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities.
Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators, and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper.
This position paper highlights 11 key positions about archiving given the distributed nature of the TMF, and the archiving of data from computerised systems to allow those systems to be decommissioned when they are no longer required in the trial. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices. The paper can be downloaded from:
EUCROF – https://www.eucrof.eu/publications
eClinical Forum – https://eclinicalforum.org/en-us/Downloads
The position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO eConsortium, Medicines for Europe and the RQA. The task force has included representatives from the pharmaceutical industry, investigator and institution sites, contract research organisations and vendors of computerised systems to the clinical trial industry.
Note, the recording of each of the above webinars is available in the eLearnIN Platform if you wish to listen to it. 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, 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.
- EMA-GCP IWG virtual meeting with interested parties on AI in clinical trials on 14 September 2021. Attendees for EUCROF will be Sofoklis Kyriazakos & Yoani Matsakis.
- EMA CTIS Stakeholder Meeting – Virtual meeting on 22 September 2021 attended by Dr Martine Dehlinger-Kremer, Dagmar Chase, and Simon Lee
- EMA Clinical Trials Information System Joint Controllership Arrangement meeting on 22 September 2021 – Virtual meeting attended by Yoani Matsakis and Kate Smirnova.
- Enpr-EMA Coordinating Group Meeting on 23 September 2021 - Virtual meeting attended by Dr Martine Dehlinger-Kremer
- EFGCP/DIA Paediatric Conference "Better Medicines for Children" on 18 - 19 October 2021 attended by Dr Martine Dehlinger-Kremer. She opened, closed and moderated the conference.
The EMA’s CTIS team have published the fourth issue of the Clinical Trials Information System newsletter “CTIS Highlights”. The newsletter provides you with insights on CTIS and how organisations can prepare for CTIS go-live.
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. At the most recent Stakeholder meeting, the EMA confirmed that the implementation of the CTIS was still on track for this date.
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, Marieke Meulemans, who, is currently representing, on behalf of EUCROF, EFPIA, Vaccines Europe, ACRO, EUCOPE, EuropaBio, and EFPIA, the commercial sponsors in the CTIS Training Expert Group for Modules 19 and 20 recently provided the following update to EUCROF members.
“With the last module for Sponsors (19) created, the Sponsor training catalogue is 100% complete (up to further notices/developments currently not foreseen).
A recap / current status of CTIS learning development:
- In Batch 5 the following modules were developed: Module 19: CTIS for SMEs and academia (for Sponsors) and Module 20: Assess an Annual Safety Report (for Member States).
- With Batch 5 finalised, only 3 additional modules are to be developed by EMA:
-
- Module 21: Introduction to CTIS for Public Users
- Module 22: Manage Union Controls
- Module 23: Business Intelligence Reporting
- A Training Guide / overview of CTIS elearning modules was developed, and a Sponsors handbook.
- CTIS Training programme evaluations will be communicated initially through the CTIS stakeholders group (part of CTIS governance) and subsequently other channels the outcome of the sponsor Master Trainer program.
CTIS Sandbox access: Around October 15th, the MS Master Trainers received a number of generic accounts that allows them to better organise training for colleagues within their [MS: NCA, ethics committees] organisations with support of the CTIS Sandbox. The rollout will thereafter follow for sponsor Master Trainers and their related users Mid-November as they finish their [theoretical] CTIS sponsor MT training programme, and thereafter to a wider user community including sponsors and any additional MS users in a third wave.
Marieke is part of the Dutch CTR/CTIS implementation Steering Group (including stakeholders from the Dutch Member State, Academia, Sponsors and Hospitals), who are still facing challenges in the dissemination of CTIS knowledge to the end-user. To facilitate dissemination and encourage the use of the EMA CTIS e-learning modules, Marieke provided several webinars to CRO and Sponsor staff in collaboration with the Dutch Association of CROs (ACRON), which was well received.
If you would like Marieke to present a similar webinar to your association, please don’t hesitate to contact Marieke directly via This email address is being protected from spambots. You need JavaScript enabled to view it..
Please remember to find the online training modules here.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 - September 2021 issue
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.
- The European Medicines Agency has published for public consultation a “Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells”.
This guideline describes the information to be included in the Summary of Products Characteristics (SmPC), Labelling and Package Leaflet for Advanced Therapy Medicinal Products (ATMPs) containing genetically modified cells.
The purpose of this core SmPC, Labelling and Package Leaflet (hereby referred to as core SmPC) is to provide applicants and regulators with harmonised guidance on the information to be included in the Product Information (PI) of ATMPs containing genetically modified cells.
This core SmPC only covers medicinal products containing genetically modified cells, allogeneic or autologous, including viral vector modified and genome edited cells.
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 October 2021.
- The European Medicines Agency has published for public consultation the ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b.
This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.
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 20 December 2021.
- The Clinical Trial Information System (CTIS) Sponsor Handbook is now available on the EMA website.
The handbook provides clinical trial sponsors with simple guidance on topics related to sponsor preparedness and use of CTIS, including links to reference material.
The handbook, developed in collaboration with sponsor user representatives, can be used by pharmaceutical companies, contract research organisations, small and medium-sized enterprises, academic sponsors, and other organisations working on clinical trials.
A set of prioritised topics has been defined for the first version, but additional topics will be added to next versions.
The European Commission has confirmed that the entry into application of the Clinical Trial Regulation and hence the go-live date for the CTIS will be on 31 January 2022. More information can be found in EMA’s news item here.
EMA has created an extensive training programme to help clinical trial sponsors prepare for using CTIS. Modules are available for use on the CTIS online modular training programme webpage on the EMA website.
- New regulatory framework for veterinary medicines (Regulations 2019/6 and 2021/16, Article 9(h)) requires the following changes to the EudraGMDP database which will come into effect from 28 January 2022:
- Integration of EudraGMDP with EMA’s Organisation Management Service (OMS);
- Extension of the two following modules of EudraGMDP to the veterinary domain:
- Wholesale Distribution Authorisations (WDA)
- Active Pharmaceutical Ingredients Registration (API-Reg).
The most notable change is the integration of EudraGMDP with OMS. From 28 January 2022, users of EudraGMDP from national competent authorities will no longer introduce organisational data (organisation name and location address details) directly into the relevant fields on the EudraGMDP database. Instead, they will select the relevant organisation name and location address details, including the legally registered address, of the manufacturers/importers/distributors from the Agency’s organisation dictionary (so-called OMS). This change will be reflected in the associated human and veterinary associated documents (including MIAs, WDAs, GMP Certificates, GDP certificates, API Registration) and investigational medicinal products (including MIAs, GMP Certificates). This change will ensure more reliable data in the system through the consistent use of organisation master data in EudraGMDP, reduce the need for data entry and cleansing, and enhance consistency of these master data across other EU IT systems and projects, e.g. Clinical Trials Information System and Union Product Database.
It will only be possible for a national authority to issue a document on EudraGMDP from 28th January 2022 if the relevant organisation master data is available in OMS. This applies whether the document is being issued on EudraGMDP for the first time following a new application (e.g. new MIA, WDA, Active Substance Registration) or where a document is being re-issued (e.g. a new version of the MIA following a variation to the existing information). The same applies for certificates issued on EudraGMDP following an inspection process.
It is therefore necessary that all organisations currently regulated through EudraGMDP (which appear on documents within EudraGMDP, including EU and non-EU manufacturers, importers and distributors of human and veterinary medicinal products and active substances) are registered in OMS.
In order to assist in populating data into OMS, EMA has undertaken a project to map existing organisation data associated with sites which are listed on various documents within EudraGMDP to OMS. As the data is introduced into OMS, it is checked for accuracy and cleansed through a standardised process. As a result of the standardisation used by OMS, it is possible that this could result in minor changes to the organisation data currently in EudraGMDP. This process will not affect existing documents on EudraGMDP (e.g. MIA, GMP Certificates, WDA etc.).
As of 28 January 2022, before applying for a new/updated manufacturing or wholesale distribution authorisation with national competent authorities, please check whether your organisation is correctly registered in OMS.
- HMA-EMA joint Big Data Steering Group we are pleased to announce two upcoming stakeholder events.
On 30 November 2021, the Agency will host a webinar on Learnings Initiative for Optimal Use of Big Data.
The objectives of this workshop include to:
- review lessons learned from submissions of real-world data in regulatory applications and discuss future perspectives for big data submission;
- discuss challenges of using innovative methods in the use of big data for regulatory purpose;
- discuss mechanisms for stakeholders’ input on future developments.
On 7 December 2021, the 2nd EU Big Data Stakeholder Forum will take place.
The objectives of this Forum include to:
- inform on current achievements and future plans;
- listen to stakeholders’ views;
- discuss areas for collaboration.
Both events will be held as virtual meetings. To enable wide participation, the events will be broadcast and a recording made public. We anticipate space for a broad representation of stakeholders, and attendance will be organised through EU associations and by direct invitations.
- The European Medicines Agency has published for public consultation the ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – addendum.
- 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 8 December 2021.
The GA will take place on Thursday 2nd to Friday 3rd December 2021, face to face in Munich, Germany. As always, this will be an important meeting to evaluate the status of current initiatives and agree on future initiatives for 2022 and beyond for EUCROF.
More information will be sent to all our Member Associations in the coming weeks, 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 on 7 and 8 February 2022, so only 3 months to go! Planning is making good progress with the programme being almost final. There will be distinguished speakers, all recognised experts in their field, as well as representatives from the EMA, the EU commission, Ethic Committees, Industry and Patients’ Associations.
The three committees (Programme, Organising and Communications Committees) are working to make the Conference happen and be a success. Our thanks and recognition to all Committee members for their effort and commitment so far and in the coming months.
Please see the link below to start promoting our Conference in Madrid in Feb 2022, by showing a video on our Conference in Amsterdam in February 2020.
Please “like” and “share” with your LinkedIn account in order to widely distribute the information.
(https://www.linkedin.com/feed/update/urn:li:activity:6671711457748504576).
Thank you in advance for your support and participation to the Conference!
The Events and Training Working Group has worked on finalising another exciting new initiative:
- “Personalised Medicine - Current applications in clinical practice and regulatory framework” -– virtual training on 2nd November 2021 from 10,00 to 15,30.
Training Objectives:
- Provide an overview of Personalised Medicine and its current applications in clinical research.
- Explain personalised medicine principles, the development and use of biomarkers and the impact of pharmacogenomics that will be illustrated by a series of case studies.
- Allow participants to be more familiar with clinical trial design, the EU regulatory framework and the ethical challenges in the era of personalised medicine.
Attendance Fee: € 225 - for non-EUCROF members and € 150 - for EUCROF members
Registration deadline: 31 October 2021
Keep consulting our website for 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..
Attendance Fee: € 90 - for non-EUCROF members and € 60 - for EUCROF members
Keep consulting our website for 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.
Workshop - “Personalised Medicine - Current applications in clinical practice and regulatory framework” – virtual meeting in Munich (Germany), on 2nd November 2021.
- 1st International Conference on Rare Diseases and Paediatric Research, 95, Rare Alliance Greece, CVBF, Athena Research and innovation centre on 18-19 November 2021 to be virtually attended by Dr Martine Dehlinger-Kremer. Member of Programme Committee & Presentation on "Clinical Trial Readiness: The patients’ contribution"
- Clinical Trials Symposium 2021, Romania 19 November 2021 to be attended by Dr Martine Dehlinger-Kremer providing the Opening Remarks of the conference and Panellist for "Deep dive into decentralised clinical trials"
- Gianni Benzi Foundation, XIV Foresight Training Course: The health emergency: regulatory crash and future perspectives –Virtual Meeting on 10 December 2021 and will be attended by Dr Martine Dehlinger-Kremer presenting "Clinical research after the COVID-19 era: the current scenario and the upcoming application of the Clinical Trials Regulation"
- Face to Face Paediatric Training - “Essentials of Paediatric Clinical Research: What you need to know when preparing, conducting and monitoring paediatric clinical trials” in Spring 2022 (TBC), to be attended by Authorities, PDCO members, Industry, Members PWG of EUCROF.
