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 [...]

Read

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 [...]

Read

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 [...]

Read

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 [...]

Read

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

Read

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

Domain specific Common Data Elements (DCDEs) Curation

CDE

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 [...]

Read