About Nicola Gover

Nicola joined JensonR+ in October 2022 and has 11 years of experience in Global Regulatory function, primarily within medicines, but also has an understanding of borderline with medical devices and non-medical classifications.

The Windsor Framework: UK Licensing Guidance

2024-01-22T13:52:03+00:00October 19th, 2023|

The MHRA issued new UK-wide licensing guidance on 29th September 2023. This provides information on how licensing changes will be implemented when the Windsor Framework takes effect on 1st January 2025. Regulatory Team Leader Nicola Gover captures the key findings from the guidance to help clients with existing or planned UK, GB or NI licences understand their next steps.

Medicinal product clinical trials review

2024-01-18T14:42:07+00:00May 2nd, 2023|

In 2022 the UK government consulted on planned revisions to the regulatory environment for medicinal product clinical trials, focusing on a more streamlined regulatory regime whilst still protecting the interests of patients. The consultation results have been published, and the resulting proposals will be taken forwards into legislation.

UK Reliance Procedure

2024-01-18T14:35:53+00:00February 2nd, 2023|

On 24th January 2023, the MHRA announced that further to the recent extension of the European Commission Decision Reliance Procedure (ECDRP) route to 31 December 2023 , from 1stJanuary 2024 there will be a new international recognition framework in place to replace it.

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