How a No-Deal Brexit Might Affect Medical Device Development: Legal Consequences and Risk Mitigation Strategies

How could a no-deal Brexit affect my medical device lifecycle?

Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is Image of Flag of Great Britain Overlapped with United Nations Flagpossible that there could be a “no-deal Brexit” scenario.

The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical devices as companies face harsh penalties for violating EU law if they don’t comply; yet they still need to meet business obligations to stakeholders, clients and patients. The political and legal situation is still evolving, and this uncertainty raises many questions for the device development pathway. Continue reading

The Role of Safety Management Plan (SMP) in Clinical Trials

Introduction

As Pharma companies outsource end-to-end clinical trial activities (tactical and strategic) to Contract Research Organizations worldwide, it is imperative to have well-defined and comprehensive documentation of trial management activities, including related drug safety activities. The Safety Management Plan (SMP) is the specific operational plan that drives the execution of the safety related activities during a trial. The SMP is thus a key operational document delineating the respective roles, responsibilities, processes and timelines for safety activities allocated between the Sponsor, the CRO or any other vendor involved in managing drug safety; and its appropriate design and content is critical to the smooth execution of clinical trial drug safety activities.

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