Course Agenda
Day 1 (8:30 AM - 4:05 PM)

8:00 – 8:30 AM: Registration

8:30 – 10:00AM:  What is Pharmacovigilance
  • Scope of pharmacovigilance
  • Sources of pharmacovigilance data
  • SAEs, SUSARs and ICSRs

10:00 – 10:15AM: Break

10:15 – 12:00 noon:  What is Pharmacovigilance...contd
  • Narratives; causality
  • Regulations governing pharmacovigilance
  • Regulatory reports

12:00 – 1:00PM: Lunch

1:00 – 1:45PM: Group exercise: Panalba Case Study

1:45 – 2:15PM: The Pharmacovigilance Function
  • Roles and responsibilities
  • Key SOPsGxP (GCP/GMP/GPvP/GPeP)
  • Signal detection

2:15 – 2:35PM: Break

2:35 – 4:05PM: The Pharmacovigilance Function...contd
  • Elements of a Safety Management Plan
  • Other key documents (e.g., IBs, SDEAs)
  • Drug Safety Databases
  • Ethics SOP
 
Day 2 (8:30 AM - 4:00 PM)

8:30 – 10:00AM: Coding Systems
  • MedDRA
  • WHO Drug Dictionary
  • ICH, CIOMS

10:00 – 10:15AM: Break
10:15 – 12:00 noon:  REMS
  • Elements of a REMS
  • Uses of a REMS
  • Examples of successful and unsuccessful REMS

12:00 – 12:45PM: Lunch

12:45 – 1:30 PM: Group exercise: Safety signals/NSF

1:30 – 2:15PM: Pharmacoepidemiology
  • What is pharmacoepidemiology
  • Sources/uses of pharmacoepidemiology data
  • Some examples of using pharmacoepidemiology

2:15 – 2:30PM: Break

2:30 – 4:00 PM: Miscellaneous and Wrap-up
  • The ISS
  • "Special" adverse events
  • Wrap-up