Save the date: ECRIN CTU Day 26 November 2021
Friday, October 1, 2021,
ECRIN aims to strengthen collaboration and open the dialogue among the CTUs from the CTU networks in ECRIN’s Observer/Member countries. For this reason, we are pleased to announce the first ECRIN CTU day will be held from 10:00-13:00 CET 26 November 2021 online. It is open to personnel from CTUs of ECRIN’s national partners. Details on ECRIN’s activities and its regular collaboration with CTUs and national hubs will be highlighted. A practical use case will cover a variety of aspects related to the setup and management of a multinational clinical trial. Stay tuned for more details and visit ECRIN CTU Day page.
PedCRIN final event
Friday, June 4, 2021,
The PedCRIN (Paediatric Clinical Research Infrastructure Network) consortium will host a final event “Fostering International Paediatric Clinical Research” on June 16th 2021, from 9:30 to 13:00 CEST. The free online event will bring together stakeholders in paediatric and neonatal clinical research to discuss the key outcomes and accomplishments. PedCRIN comes to an end on June 30th 2021 and there is much to share from this project which includes direct support to clinical trials and the development of tools to facilitate clinical research in the paediatric and neonatal communities.
For more information on PedCRIN or the Final Event: Fostering International Paediatric Clinical Research, visit the PedCRIN website or contact PedCRIN via mail at firstname.lastname@example.org
PedCRIN website: http://www.pedcrin.org
Registrations for the final event: Link
Don't miss International Clinical Trials Day: 20 May 2021
Wednesday, April 14, 2021,
In light of the current pandemic, ECRIN is organising a virtual event for International Clinical Trials Day (ICTD) on May 20th, 2021.
ICTD 2021 will bring together stakeholders from across Europe and the globe to discuss the growing interest in platform trials from best practices to challenges in the European context. ICTD is open to research organisations, clinical research professionals, patient organisations, regulatory and ethics bodies, funders and industry.
The theme of this year's event is Platform Trials: Shift in Treatment, Testing and Collaboration. This new trial format raises many questions, changes our approach to conducting clinical trials and testing for appropriate treatments.
The virtual event (10:00 – 16:00 CEST) is free and open to all.
REGISTRATION IS NOW OPEN on the ECRIN website
JOIN US! May 20th 2021 is International Clinical Trials Day
Thursday, February 18, 2021,
On this day we commemorate the launch of James Lind's clinical trial which laid the groundwork for modern-day clinical research. This year we will bring together stakeholders from across Europe and the globe to discuss the growing interest in platform trials from best practices to challenges in the European context.
Registration opening soon 👉 https://ecrin.org/events/ictd2021
EMA two-part CTIS training event targeted at SME and academia
Wednesday, January 20, 2021,
A two-part CTIS training event targeted at SME and academia clinical trial sponsors (future CTIS users and their organisations).
Day 1: 22 Feb 2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 1 | European Medicines Agency (europa.eu)
Day 2: 4 Mar 2021 SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 2 | European Medicines Agency (europa.eu)
The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation and will be used by clinical trial sponsors as a single entry point in the EU to obtain approval for clinical trials based on applications and for monitoring clinical trials during their life cycle, including the submission of summary of results.
CTIS will centralise the submission process for clinical trial applications and the assessment and authorisation by Member States in a single unique platform. It will facilitate day-to-day business processes of Member States and sponsors of clinical trials throughout the lifecycle of a clinical trial harmonising submission and maintenance of trial applications, assessment and supervision of trials and promoting patient safety and transparency.
The Clinical Trials Regulation, Regulation (EU) No 536/2014, will become applicable as CTIS goes live, which is anticipated in December 2021. Once launched, CTIS will be immediately available for authorities and for clinical trial sponsors, while a three-year phased transition period from the current Directive 2001/20/EC to the Regulation will apply.
To facilitate preparedness for use of CTIS users, the European Medicines Agency has developed a training programme to provide future CTIS users with the skills and knowledge to successfully use CTIS into their business. A wide array of comprehensive online training material will be made available gradually in 2021.
For Micro, Small to Medium Enterprises (SMEs) and academia, EMA is organising a targeted webinar to provide training on CTIS and its functionalities. The webinar is divided into two parts (Day 1 and Day 2) and participants are advised to attend both. This two-part event is free of charge.
As per current planning, Day 1 on 22nd February 2021 will present CTIS access management, user management and different roles in CTIS. Day 2 on 4th March 2021 will focus on CTIS functionalities - how to submit and manage a clinical trial application. Transparency of reporting of results will also be presented on Day 2.
The webinar will include presentations by speakers from EMA system experts and presenters from SME and academic institutions, demonstration of the system, and opportunities for questions and answers. The webinar will be recorded and published for future perusal.
❗️❗️Steps to take:
1) Express your initial interest in this two-part CTIS training event aimed at SMEs and academia by completing the expression of interest questions: EUSurvey - Survey (europa.eu). This initial expression of interest should be made by the 29th January 2021 but is not yet the registration to the training.
2) Based on expressions of interest, you will receive a separate email from EMA including a link to register for the training in the week commencing on 1st February 2021. Registrations will close on 7th February 2021. You will need to register for both dates individually.
Due to the platform used, this two-part CTIS training event is limited to 950 participants. Should more participants express interest to participate, preference will be given to those representing academic institutions and SMEs. The criteria for being classified as an SME can be found here.
- EMA support for SMEs, please see https://www.ema.europa.eu/en/human-regulatory/overview/supporting-smes
- EMA engagement with academia, please see https://www.ema.europa.eu/en/partners-networks/academia
Research Data Management and Open Data Course
Thursday, June 4, 2020, Webinar
APRE training programmes provide potential applicants/eligible participants in the European Commission programmes with support throughout the entire project life cycle: from project idea to management, reporting and exploitation of project results.
The training course on "Research Data Management and Open Data" is divided into 4 webinars.
The aim of the course is to provide tools for the correct management of research data and open science cloud (EOSC).
For more information, please visit APRE website.
Workhsop - Roadmap Initiative to Good Lay Summary Practices
Wednesday, January 15, 2020, Crowne Plaza Le Palace, Brussels, Belgium
Learn about the draft Lay Summary Best-Practice Guideline elaborated in response to the Clinical Trial Regulation and take the opportunity to impact the version that will be disseminated for public consultation
The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical study results from commercial and non-commercial sponsors. Several large companies have already generated experience with creation of Lay Summaries and in the USA guidance on Lay Summary content have already been developed.
Also, EMA has released an Expert Group Recommendation on the content of Lay Summaries. However, there is no guidance for all types of sponsors on how best to handle the development process of Lay Summaries and how best to ensure reliable dissemination so that the ultimate goals can be achieved: increase of clinical research transparency, patients’ and public’s understanding of clinical research, as well as feedback to study participants about the results of their study.
To create a suitable, mutually acceptable framework for Lay Summaries a consorted effort of all involved stakeholders is required.
Some of our keynote speakers and faculty will be:
Edit Szepessy, DG SANTE, EU Commission
Till Bruckner, TranspariMed
Kaisa Immonen, EPF
Barbara Bierer, MRCT Center, Harvard Medical School
Debra Gueirrero, Janssen
Nicola Ruperto, Ospedale Pediatrico Istituto Gaslini
Sabine Kläger, ECRIN
Thomas Schindler, Boehringer Ingelheim
Begonya Nafria Escalera, San Juan de Deu Hospital
Lotte Klim, EUPATI Fellow
Amanda Hunn, AJ Associates
Behtash Bahador, CISCRP
Sini Eskola, EFPIA.
Still time to register! Click here: https://form.jotformeu.com/93291775221358
Facilitating High Quality Multinational Clinical Research in Europe: ECRIN Mission and Vision
Wednesday, October 23, 2019, Istituto Superiore di Sanità
A meeting entitled 'Facilitating high-quality multinational clinical research in Europe: ECRIN mission and vision' will be held at the Istituto Superiore di Sanità (ISS) on 23 October 2019.
ISS coordinates the Italian Clinical Research Infrastructure Network (ItaCRIN), which aims to sustain independent clinical research and help investigators/sponsors promote (and join) multinational trials supported by ECRIN.
The purpose of the event is to improve knowledge of ECRIN and to encourage Italian participation in international trials, by promoting high-level, non-profit clinical research focused on the identification of innovati ve therapetuic strategies for the the benefit of public health.
The conference is aimed at researchers and clinical investigators, medical doctors, grant office staff, clinical research organisations (CROs), and clinical trial unit (CTU) staff.
Participation is free-of-charge, but registration is required.
Learn more on the ISS website, or contact Maria Buoncervello.
Giornata di lancio bandi H2020 – Infrastrutture di ricerca: last call 2020
Tuesday, October 22, 2019, MIUR, Viale Trastevere 76/A Sala Aldo Moro (Ex Sala della Comunicazione), Rome
Organized by APRE, MIUR