News Archive

ICH - ICH Q9(R1) IWG Updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers

12th December 2024

Now available on the ICH website

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MHRA - MedRegs Blog, December 2024

12th December 2024

Festive reflections on Med Tech

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MHRA - new clinical trials framework being laid in parliament today

12th December 2024

Patients, the NHS and the Life Sciences sector set to benefit from new clinical trials framework being laid in parliament today

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EMA - Data Quality Framework for EU medicines regulation: application to Real-World Data Public Consultation

11th December 2024

The European Medicines Agency has published for public consultation a new document: Data Quality Framework for EU medicines regulation: application to Real-World Data.

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EMA - HMA-EMA Real-World Data (RWD) Catalogues Survey

11th December 2024

Following their launch in February we are interested to know about your experience with the RWD Catalogues and how we could further improve them.

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EMA - The European Medicines Agency has published for public consultation the ICH Guideline for Good Clinical Practice E6(R3) Annex 2

11th December 2024

Comments by 28th February 2025

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EMA - public consultation the ICH M15 Guideline on general principles for model-informed drug development

11th December 2024

This guideline provides general recommendations for planning, model evaluation, and documentation of evidence derived from Model-Informed Drug Development (MIDD).

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