Essential pharmacovigilance training for those who need greater detail.
This 60 min* ‘Step 2’ online training covers essential PV in more depth. It is ideal for those who need a more detailed knowledge of PV.
• What is and what governs PV
• Roles and responsibilities
• Key PV process steps; safety information and its capture
• Product safety oversight
• ADRs – basic facts, solicited v unsolicited reports
• Expedited individual case safety reporting
• MedDRA coding
• Periodic safety reporting, PSURs, PBRERs, DSURs
• Risk management planning
• Safety signals
• Reference safety information
• PV system master file
For details of packages for training larger groups contact us at firstname.lastname@example.org