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MHRA - Drug Safety Update, March 2024

28th March 2024

The monthly newsletter from the Medicines and Healthcare products Regulatory Agency and its independent advisor the Commission on Human Medicines

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MHRA - warning of unsafe counterfeit anti-choking devices

28th March 2024

Thousands of counterfeit or unbranded copies of LifeVac anti-choking devices are being sold across the UK. The public is reminded to check their product carefully against the images in MHRA guidance to identify whether it is a counterfeit.

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Veterinary Scientific Guidance Update

28th March 2024

EMA and VICH Adopted and Draft Guidance.

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WHO - Second Week of Quality Training Announced

28th March 2024

WHO is pleased to announce the second edition of its Week of Quality training program, focusing on In Vitro Diagnostics (IVDs) in 2024. Week of Quality for In Vitro Diagnostics (IVDs): April 15-18, 2024 Week of Quality for Medicines: May 13-16, 2024 Week of Quality for Vaccines & Biotherapeutics: June 10-13, 2024

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Gov UK - Disgraced company director convicted of falsifying medicine quality data

22nd March 2024

A company director and his pharmaceutical manufacturing company were sentenced in court today after pleading guilty to two charges of falsifying data that supported the shelf life of a medicine, adversely affecting its quality in order to obtain a licence to sell the medicine in the UK.

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EC - CTD to CTR Guidance

13th March 2024

Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation

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EMA - DARWIN EU® continues expanding its capacity to deliver real-world data studies

13th March 2024

The Data Analysis and Real World Interrogation Network DARWIN EU seeks ten new data partners in 2024.

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EMA - Human Medicines Newsletter 178

13th March 2024

Edition 178, March 2024

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EMA - Meeting highlights from the PRAC 4-7 March 2024

13th March 2024

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)

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FDA - Final Guideline: Q14 Analytical Procedure Development AND Q2(R2) Validation of Analytical Procedures

13th March 2024

Released March 2024

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