EJPRD- ERICA 3rd Joint Workshop “Finding RD registry data in the Virtual Platform”

ERICA EJPRD Joint WS

This workshop is the third of the ERN data strategy workshop series. It is dedicated to the various stakeholders expected to interact with the EJP RD Virtual Platform.

In this workshop, the feedback received from the ERN registries on the level of discovery that should be authorised for either anonymous or authenticated users of the Virtual Platform will be discussed first. The practical use of the VP will be presented in a Demo session. Subsequently, a hands-on session will allow participants to test the Virtual Platform and provide their feedback. Researchers as well as stakeholders from industry, the member states [...]

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ERICA WP3 ‘Patient centred research’ Expert Working Group Kick-off Meeting 8-10 March 2-5 pm

WP3 PCEWG meeting

We are glad to start the new ‘ERICA year’ with the Kick-off meeting of WP3 Patient Centred Expert Working Group (PCEWG) that will be held in two consecutive sessions on Tuesday 8th and Thursday 10th March 2022 from 2 to 5 pm (CET).

Session I will be dedicated to present the work done so far for the identification and codification of instruments for the assessment of Patient Reported Outcomes (PRO) in rare diseases (RD). Session I will give the frame for an open discussion in Session II to better understand and define the RDs community needs in terms of building [...]

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EMA Virtual meeting Repurposing ‘WALK-IN’ CLINIC

EMA

The pilot project to support the repurposing of medicines was launched at the end of October 2021 by EMA and the Heads of Medicines Agencies (HMA)

To support not-for-profit organisations and academia ahead of the upcoming deadline for submission (28th February 2022), EMA is hosting a ‘walk-in’ clinic webinar on 17 February 17h-18h30. Representatives of the Repurposing Observatory Group leading the pilot will also participate to the webinar.

EMA together with representatives of the Repurposing Observatory Group (RepOG) is organising this open event to:

provide a brief reminder of the Repurposing pilot provide information on how EMA real-world evidence [...]

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EJPRD- ERICA Joint Workshop “Finding RD registry data in the Virtual Platform”

ERICA EJPRD Joint WS

A hands-on session will be held for you (as Virtual Platform (VP) end-users) to test the first version of the VP, provide feedback and address any further open questions.

This workshop is the second of the ERN data strategy workshop series. In this workshop, different approaches to making data and cases safely findable via the EJP RD Virtual Platform (VP) will be described, along with a short technical overview of how this is achieved.

This includes an elaboration of the difference between Resource Discovery (incorporating completely safe querying of very limited/obfuscated data fields) and far deeper Record Interrogation queries by [...]

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EMA Webinar for SMEs and Academia on the Clinical Trials Regulation and the Clinical Trials Information System

EMA webinar

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 [...]

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ERN Workshop on Endocrine cancer: A challenge in adults and children.

ERN Workshops (9)

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

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EMA is launching a pilot to support the repurposing of established medicines for use in new indications by NGOs and academia.

EMA medicines

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 Read