Consultations

Laatst bijgewerkt op: 28 november 2020, 19:48 uur

conect4children: Survey of research staff experience and knowledge in drug supplies management in delivering investigator-initiated paediatric clinical trials

Geen sluitingsdatum bekend

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EDPB: Recommendations 01/2020 on measures that supplement transfer tools to ensure compliance with the EU level of protection of personal data

Consultatie open tot 30 november 2020

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European Commission: Standard contractual clauses between controllers & processors located in the EU (implementing act)

Consultatie open tot 10 december 2020

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European Commission: Standard contractual clauses for transferring personal data to non-EU countries (implementing act)

Consultatie open tot 10 december 2020

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MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions

Consultatie open tot 12 december 2020

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EMA: Guideline on registry-based studies

Consultatie open tot 31 december 2020

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WHO: Good manufacturing practices for investigational products

Consultatie open tot 6 januari 2021

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EMA: Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) – Rev. 4

Consultatie open tot 13 januari 2021

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EMA: Draft guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) – Rev. 6

Consultatie open tot 13 januari 2021

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EMA: Draft guideline on the evaluation of anticancer medicinal products in man – Revision 6

Consultatie open tot 15 februari 2021

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EMA: Appendix 3 to the guideline on the clinical evaluation of anticancer medicinal products – Summary of Product Characteristics for an Anticancer medicinal product – mock-up of 4.8

Consultatie open tot 15 februari 2021

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