Pharmacovigilance and Safety Reporting in Clinical Research
This one-day workshop will cover the principles of pharmacovigilance as well as the reporting requirements for both sponsors and investigator sites. The scientific justification for pharmacovigilance will be described as will the importance of benefit-risk assessment in clinical trials.
Who Should Attend
This workshop is designed for NHS / academic staff whose role involves pharmacovigilance governed by the regulations required for clinical trials of medicinal products. For example, sponsor representatives, investigators, research nurses, trial managers, project managers, QA staff or R&D staff. Management staff who supervise staff responsible for pharmacovigilance reporting, or clinical research staff preparing for GCP audit or GCP inspection, will also find this workshop of interest.
- It will be an interactive day with a combination of presentations, discussions and workshop. By the end of this workshop, participants will be able to:
- Define the scientific principles of pharmacovigilance and benefit-risk assessment in clinical trials
- Describe the requirements of adverse event recording and medical evaluation and assessment
- Define serious adverse events (SAEs), a serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARs)
- State the reporting requirements at the investigator site and sponsor level
- Develop a development safety update report (DSUR)
- Understand the requirements of EudraVigilance
- Be aware of the changes to pharmacovigilance legislation and the impact on clinical research
- State at least 3 examples of non-compliance around adverse event and serious adverse event reporting
As it is only 1 day pre reading is required prior to attendance.
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