ERC PROOF OF CONCEPT GRANTS

Published by European Commission (EC)

Proof of ConceptERC

Size of ERC Proof of Concept GrantsThe financial contribution will be awarded as a lump sum of EUR 150 000 for a period of 18 months. The ERC expects that normally proof of concept activities should be completed within 12 months. However, to allow for those projects that require more preparation time, the grant agreements will be signed for 18 months. Extensions of the duration of proof of concept projects may be granted only exceptionally.

The lump sum will cover the beneficiaries’ direct and indirect eligible costs for the project: if the project is implemented properly the amounts will be paid regardless of the costs actually incurred. The lump sum has been designed to cover the beneficiaries’ personnel costs, subcontracting, purchase costs, other cost categories and indirect costs.

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DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

Published by European Commission (EC)

ProcessingDonationQuality and SafetyDistributionHuman Tissues and CellsPreservation

This Directive sets the standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

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Long-term access and preservation infrastructure development for EOSC, including data quality aspects

Published by European Commission (EC)

CloudOpen Science

In the digital and data driven paradigm promoted by Open Science, data is at the core of the scientific process and its production grows at ever increasing rates. The volume of data currently is many-fold larger compared to just two years ago. In science there are many intermediate data objects being created through the phases of research activities and they are managed within the research data lifecycle in which curation and preservation are key elements to make accessible data that are interoperable and reusable. Costs and physical limitations of storage and service capacity lead to the difficult question of what is worth long term preserving narrowing the selection to data and other digital objects that will have long-term benefits to science and society.

Coordination to harmonise practices and standards within and across the different scientific fields and adequate infrastructures are necessary to implement the level of curation and preservation needed and to offer the related services that differ in practice and effort per discipline ant type of data.

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Commission Notice Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another 2022/C 440/02

Published by European Commission (EC)

Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another

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COMMISSION DIRECTIVE (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance)

Published by European Commission (EC)

human cellshuman tissuesTechnical Requirements

This Comission Directive sets up measures concerning traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.

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EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

Published by European Commission (EC)ECRIN

Clinical Trials Toolkit

Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level. The Annex also includes guidance on ordering, shipping, and returning clinical supplies, which are at the interface with, and complementary to, guidelines on Good Clinical Practice.

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