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MHRA ramps up assessment capacity for in-vitro diagnostic devices

MHRA ramps up assessment capacity for in-vitro diagnostic devices

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the designation of UL International UK Ltd as an Approved Body.

30 Jan 2023
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EC adopts proposal to allow more time to certify medical devices

EC adopts proposal to allow more time to certify medical devices

Fears of a shortage of medical devices have led the European Commission (EC) to adopt a proposal to extend the transition period to new rules under the Medical Devices Regulation. The proposal was made at the EPSCO Council meeting on 9 December 2022 by EU health ministers.

23 Jan 2023
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EMA reminder that clinical trials must use CTIS

EMA reminder that clinical trials must use CTIS

The European Medicines Agency (EMA) has issued a reminder that from 31 January 2023 clinical trial sponsors must use the Clinical Trials Information System (CTIS) for initial trial applications.

9 Jan 2023
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Challenges and Trends in Medical Affairs

Challenges and Trends in Medical Affairs

Medical affairs is an increasingly complex discipline. It is vital that the team is highly trained and able to adapt to an evolving environment, liaising effectively with stakeholders to communicate value and bring new treatments to the market. Read on to discover some of the challenges and trends affecting the sector.

30 Nov 2022
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