News Archive

EMA - Public Consultation - CTR and CTIS

21st June 2023

Public consultation on the transparency rules for the operation of the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS)

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EMA - Human Medicines Highlights Issue 170

20th June 2023

Issue 170, June 2023

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 June 2023

20th June 2023

Meeting Highlights

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 - 8 June 2023

20th June 2023

Meeting Highlights

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EMA - workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use

20th June 2023

Building upon the experience of the submission of real-world evidence for regulatory purpose and the conclusions of previous activities around data standardisation, metadata, data quality and DARWIN EU®.

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FDA - FDA Roundup: 16 June, 2023

20th June 2023

A roundup of FDA news

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FDA - Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry

20th June 2023

This guidance provides information to sponsors and nonclinical laboratories regarding the use and management of whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice (GLP)-compliant nonclinical toxicology studies using non-human specimens.

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MHRA - Implementation of medical devices future regime

20th June 2023

The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.

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MHRA - New lay commissioner appointed to the Commission on Human Medicines

20th June 2023

Mr David Crundwell joined the Commission on Human Medicines on 12 June 2023 as a lay representative.

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WHO - Countries set out way forward for continued negotiations on global agreement on pandemic prevention, preparedness, and response

20th June 2023

Countries of the World Health Organization (WHO) have moved forward negotiations on a global accord on pandemic prevention, preparedness and response, with a view to presenting a draft accord to the World Health Assembly in May 2024.

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