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Explanation for animal owners and veterinary health professionals on how the VMD calculates adverse event incidence rates for veterinary medicines
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
This Adverse Weather and Health Plan (AWHP) equity review and impact assessment reviews existing evidence of the risks posed by adverse weather to different populations. It outlines next steps to improve understanding of these risks.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Urgent and clinically significant safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Organisational definitions of terms concerned with risk and risk-related matters.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
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