Pharmacovigilance is science relating to detection, assessment and prevention of adverse effects of drugs. Improving drug safety is a task concerning not only regulatory authorities and pharmaceutical industry but also prescribing physicians. This is done right from the drug research and development stage to post marketing drug surveillance.
This course will provide extensive theoretical & training in Pharmacovigilance. All the topics will be presented by team of real time professionals. It incorporates end-to-end theoretical & practical training on Pharmacovigilance processes including case assessment practical’s (seriousness of the events, reportablity of case, expectedness of the event), Data Entry, Case Processing, meddra & WHODD coding & Narrative Writing.
- Introduction to Pharmacovigilance
- Clinical Development process
- Drug Safety in clinical trials and post marketed drugs
- Different sources of Adverse events reporting
- Different types of AE reporting Forms
Adverse events and its types.
- Expedited reporting and its timelines
- Four minimum information for a reportable case.
Seriousness criteria of adverse event.
- Expectedness (Listedness) of adverse event
- Causality assessment of the adverse event
- Case Narrative writing
- Case processing
- Roles & Responsibilities in a CROs & Sponsor in Pharmacovigilance
- Medical Dictionary for Drug Regulatory Activities – Medora
- Overview of Oracle Argus
- Periodic Safety Update Report (PSUR) and its submission time lines.
- Development Safety Update Report (DSUR).
COURSE DURATION- 45 hours (45 days)