News Archive

RQA - Collaboration Agreements

14th November 2024

Collaboration is always high on the agenda; RQA has several initiatives in the pipeline, with many more under discussion.

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FDA - Roundup - 8th November 2024

8th November 2024

An at-a-glance summary of news from around the agency.

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MHRA - Statement of policy intent: relaunch of the Innovative Licensing and Access Pathway

6th November 2024

The Innovative Licensing and Access Pathway (ILAP) aims to get the most transformative new medicines to patients in the National Health Service (NHS) more quickly.

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EMA - CTIS Newsletter - 5th November 2024

5th November 2024

Latest CTIS newsletter released

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MHRA - Emerging Roadmap and transition provisions

1st November 2024

New MHRA Blog Post

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FDA - In September 2024, the U.S. FDA issued a Warning Letter to the Indian company MMC Healthcare Ltd.

17th October 2024

Inspected March 2024

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EMA - Veterinary Scientific Guidance Update

4th October 2024

EMA adopted and draft guidance

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VICH - Veterinary Scientific Guidance Update

4th October 2024

New Guidance

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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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