The open consultation will close on 21 December 2022.

The open consultation can be accessed through this link: http://enquetes.agencerecherche.fr/index.php/survey/index/sid/976696/lang/en

This questionnaire will take around 30 min to complete.
More information here: https://www.icpermed.eu/en/EP-PerMed-SRIA-Consultation.php 

This report is based on scientific articles and press releases published between 2019 and 2021; it seeks to inform stakeholders and the rare diseases community about the developments and observed trends in the field of rare diseases research.

A chapter is dedicated to an update on the global rare diseases research landscape for the past ten years to celebrate IRDiRC’s 10th anniversary.

Read the report here: https://irdirc.org/resources-2/state-of-play/

She requests healthcare professionals (Medical doctors, Nurses, Physiotherapists, etc.) involved in the treatment of rare diseases to complete a questionnaire.

The results of this study will be used in future publications and in student’s PhD thesis.  

Access the questionnaire here:  https://ec.europa.eu/eusurvey/runner/hsr

This survey aims to identify factors that influence the process of obtaining a diagnosis and obstacles along the journey.

This is a global survey, available in 26 languages.

The ambition is to collect relevant responses at the national level and for specific disease areas, while developing an image of the diagnostic journey for our global community.

Following the survey, RDI members can access findings for their country or a disease area in a detailed digital dashboard with all results.

This is an excellent opportunity to ensure your organisation has significant data on diagnosis for the country or disease area you represent.

Deadline for the survey: 15 June

Start Survey

Additional Information

This study is part of a larger project funded by the National Human Genome Research Institute. The aims of this project are to:

• Study relevant factors that influence whether and how DACs implement workflow solutions that improve consistency and efficiency of data access review and to
• Develop procedural standards for DACs using an international, consensus deliberation approach

 Your participation in the survey is completely voluntary. No identifiable information about you, your institution, or your responses, will be shared outside of the study team. This study was approved by the Stanford University IRB.

The deadline for providing feedback to the Draft SRIA is October 29^th, 2021.

The draft SRIA was prepared by the Working Group on SRIA and the contribution by selected experts. In particular, ERA4Health and its SRIA aim at:

• Supporting relevant medical research including clinical fields and interventions area (prevention, diagnosis and treatment).
• Conducting large, multinational non-commercial/pragmatic clinical trials within the (new) regulatory framework for clinical trials. ERA4Health will connect clinical research capacities and research infrastructures of high public health interest.

Relevant stakeholders include: decision makers, research and innovation funding bodies, relevant national and regional stakeholders and experts (e.g. Health and Care providers, Public Health experts, researchers, Health and Care Innovators, enterprises, civic and patient associations, Health and Care professionals and formal and informal carers associations).

More information: https://ec.europa.eu/eusurvey/runner/era4healthopenconsultation

In this scenario, the European Paediatric Translational Research Infrastructure (EPTRI) and the EU-funded RESTORE project are collaborating to describe the map of competences available in the framework of the paediatric ATMP research in pan-European countries in order to have the chance to promote the development of tailored paediatric advanced drugs and facilitate collaborations.

To this aim, a survey has been developed and it is available at this link.

The survey is addressed to professionals involved in the development of ATMPs and it takes around 20 minutes to complete.

Complete the survey here to help us improve the Networking Support Scheme, the EJP RD funding opportunity for networking.

Please note: if you are a principal applicant or an evaluator of the Networking Support Scheme, you will receive another survey via e-mail.

To learn more about the Networking Support Scheme funding opportunity please click here.

If you are part of Patients’ & Healthcare Professionals’ organisations or a Learned Societies, the European Medicines Agency is seeking for expressions of interest from you to participate in this initiative by providing feedback through the survey and taking part in the virtual data standards workshop scheduled on 18 May.

In order to move forward quickly, you can provide them with the following information by the 23^rd of April close of business:

1. One completed survey per interested organisation: You will find attached the survey questions in a PDF document for ease of dissemination across your members. In addition, here is the link to the online survey (to be opened in Google Chrome)

Please note that the survey should be completed and submitted only once by a designated person for each organisation based on the consolidated input received from its interested members.

2. The names and contact details of up to 3 representatives (expert in the field of data standardisation/use, where possible) for each interested organisation to actively participate in the workshop scheduled in May. The number of participants in the virtual room is limited to ensure a smooth running of the virtual meeting. 

Note that the workshop will be broadcast live to provide the opportunity for any additional interested colleagues to listen to the discussions

The plan is to consult a wide range of stakeholders to better understand data standardisation needs related to the submission, receipt and (re-)use of scientific data at each stage of the lifecycle of medicinal products. The idea is to optimise the processing of such data by the different stakeholdersthanks to better structured submission formats tailored to their needs while ensuring data security. 

The first consultation phase will be done in writing via an online survey to collect feedback on needs and priorities from the different stakeholders’ perspectives. All the input and use cases received will be integrated into a draft Data Standards Strategy document, that will outline a roadmap for the development and implementation of data standards with estimated timelines. This strategy will then be presented and discussed during a virtual workshop on 18 of May 2021.

Important note: The Data Standards Strategy will take into account and align with ongoing projects related to standardisation of data submissions and publication in which you may already be involved (examples: ISO IDMP, ePI, eCTD).

If you have any question do not hesitate to contact DataStandardsStrategy@ema.europa.eu