Adverse Event & Safety Reporting -Clinical Trial Pharmacovigilance

Start Date/Time:
05 November 2019 13:30
End Date/Time:
05 November 2019 15:30
NIHR/Wellcome Trust Birmingham CRF, Birmingham
Seminar Room, Wellcome Trust Birmingham CRF, Heritage Building, Queen Elizabeth Hospital, Birmingham

Target Audience: Research Nurses, Data Managers, Investigators

Aims & Objectives: As a result of this course, participants should-

  • 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
  • Be able to implement local SAE reporting procedures

Course Summary: Using short presentations, demonstrations and discussion, the programme will include-

  • Introduction
  • Different types of adverse event
  • EU legislation
  • UK legislation
  • EU Detailed guidance document
  • Complying with the legislation
  • Site specific Standard Operating Procedures
  • Workshop



On 05 November 2018