The way clinical trials are conducted in the EU will change when the Clinical Trials Regulation (Regulation (EU) No 536/2014) becomes applicable and the Clinical Trials Information System (CTIS) goes live on 31 January 2022.
The EMA is organising a webinar to remind SMEs and academic sponsors of clinical trials of the main changes brought by the Regulation and its impact on their trials-related activities.
The aim of the training is to give an overview of the Regulation and introduce the new process for submitting clinical trials information in the EU/EEA. In addition, it covers the functionalities of the Clinical Trials Information System (CTIS) as well as transparency aspects and safety reporting requirements. Guidance and training material available for sponsors are also presented.
Happy to announce that the ERICA Advisory Board is complete!
In the context of EJP RD’s ERN Workshops, a face-to-face workshop on “Endocrine cancer: A challenge in adults and children” aimed at giving an update on the molecular background and clinical management of rare endocrine malignancies is being organised by Prof. Barbara Jarzab of the M. Sklodowska-Curie National Research Institute.
The in-person event will take place on May 4th, 2022 at the M. Sklodowska-Curie National Research Institute in Gliwice, Poland.
Registration closes on January 28th, 2022 Read
EMA and the Heads of Medicines Agencies (HMA) are launching a pilot project to support the repurposing of medicines as a follow-up to the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) discussions on a proposal for a medicines repurposing framework.
The aim of this initiative is to support not-for-profit organisations and academia to gather or generate sufficient evidence on the use of an established medicine in a new indication with the view to have this new use formally authorised by a regulatory authority. This is a way of making new treatment options available to patients. Read
The European Commission (EC) has opened a new funding call titled “Tackling diseases (Two Stage – 2022) (HORIZON-HLTH-2022-DISEASE-06-two-stage)” in the context of the Horizon Europe Framework Programme on the development of new effective therapies for rare diseases.
Support for proposals from EJP RD
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In this meeting we will begin to curate the list of Domain specific Common Data Elements (DCDEs) compiled by the EJP RD FAIRification stewards from the data dictionaries provided by the ERN registries. The aim of the DCDEs is to be able to share domain specific data between ERNs, data that is not currently covered by the Common Data Elements (CDEs). Hence we would very much like to have your opinion in the curation of these data items to make sure it is maximally useful for you.
Please feel free to forward this invitation to anyone in your ERN or organisation who might be interested to join. We are particularly looking for clinicians and people with a medical background to join. We kindly remind you that the modelling work that will be undertaken by the EJP RD modelling experts will depend on the outcomes of this DCDEs curation, meaning that it is crucial to obtain an adequate picture of your needs. This will be the first of a short series of meeting to finalize the DCDEs.
Please fill in the Registration to receive the meeting link
This workshop will be the first of the ERN data strategy workshop series. During this first workshop, we will discuss the techniques and algorithms to anonymise and pseudonymise healthcare data from patients with rare diseases. A special focus will be given to the challenges associated with preserving the privacy of patients with rare diseases. The advantages and drawbacks of pseudonymised and anonymised data both in terms of research outcomes and privacy protection level will be discussed. Finally, in relation with the GDPR regulation, the legal implications of sharing anonymised and pseudonymised data with external stakeholders will be examined. Following these presentations, an open discussion and a Q & A session will be held to address open questions.
The Recording is viewable at the given Workshop Website below.
View this workshop
The European Joint Programme on Rare Diseases (EJP RD) announced the upcoming launch on December 14th of the fourth EJP RD Joint Transnational Call (JTC) 2022, aimed at funding multilateral research projects on rare diseases under the EJP-COFUND action.
The aim of the call is to enable scientists in different countries to build an effective collaboration on a common interdisciplinary research project, with the call topic being “Development of new analytic tools and pathways to accelerate diagnosis and facilitate diagnostic monitoring of rare diseases.”
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