News Archive

FDA - Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

2nd October 2024

This guidance provides information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs.

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MHRA - webinar on Implementing the new UK Clinical Trials regulations

30th September 2024

Registration now open.

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MHRA - Drug Safety Update Newsletter

27th September 2024

September 2024

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World Health Organization - 2024 Guidance for Best Practices in Clinical Trials

26th September 2024

The World Health Organisation (WHO) has developed some guidance on best practices for clinical trials was developed following extensive global input, including public consultations.

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MHRA - An update on our plans for Med Tech regulatory change

25th September 2024

New Blog Post

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MHRA - AI Airlock pilot call for applications

24th September 2024

Apply now to join the AI Airlock pilot by the MHRA. Benefit from industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.

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