Adverse Event & Safety Reporting – Clinical Trial Pharmacovigilance

Start Date/Time:
04 November 2020 09:30
End Date/Time:
04 November 2020 12:30
NIHR/Wellcome Trust Birmingham CRF, Birmingham
Seminar Room, Wellcome Trust Birmingham CRF, Heritage Building, Queen Elizabeth Hospital, Birmingham

Target Audience:           Research Nurses, Data Managers and Investigators

Aims and Objectives:  To recognise the importance of pharmacovigilance in clinical trials, be able to recognise different types of adverse events, be aware of legal requirements with regard to reporting adverse events and be able to implement local SAE reporting procedures

Course Summary:       Introduction, different types of adverse events, EU Legislation, UK Legislation,  EU Detailed Guidance Document, Complying with the legislation, Site specific Standard Operation Procedures

On 12 December 2019