News Archive

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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EMA - CTIS Newsflash, 3rd December 2024

5th December 2024

New edition out now.

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EMA - Veterinary Medicines Highlights, December 2024

5th December 2024

Quarterly news, activities and interviews from EMA Veterinary Medicines Division

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MHRA - Five Innovative AI Technology Trials

5th December 2024

MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach

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MHRA - Final Call to Comply with Windsor Framework

2nd December 2024

The MHRA issues final call to comply with Windsor Framework arrangements for medicines from January 2025

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OECD - Position Paper on Good Laboratory Practice and IT Security

2nd December 2024

This position paper was developed by the OECD Working Party on Good Laboratory Practice (GLP) via a drafting group led by Denmark (Medical Products) and consisting of Austria, Belgium, Canada, France (Medical Products), Germany and Switzerland.

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