MODULE 1 | 18 September 2024
Pharmacovigilance Documents – Basic Concepts and Definitions for Pharmacovigilance Writing

“A never ending story (life cycle management in pharmacovigilance)”

  • The life cycle of a medicinal product from the pharmacovigilance perspective
  • Basic concepts and definitions for pharmacovigilance writing
  • Benefit-risk analysis
  • Breakout sessions and interactive discussion of the results
  • Interaction of the main pharmacovigilance documents through the life cycle of medicinal products.
  • Assessment and review of key concepts

MODULE 2 | 25 September 2024
Pharmacovigilance Documents – Focus on Signal Management and Development Safety Update Reports (DSUR)

“The early phases: Signals and Trials”

  • Focus on the Development Safety Update Report (DSUR)
    • Who, when, what and how.
  • Breakout sessions and interactive discussion of the results
  • Signal management
    • Evaluation of sources
    • Signal management and data collection
    • The Signal Detection and Management Report
  • Breakout sessions and interactive discussion of the results
  • Assessment and review of key concepts

MODULE 3 | 2 October 2024
Pharmacovigilance Documents – Focus on the Risk Management Plan (RMP)

“The life beyond submission, 1: Risks and Plans”

  • Focus on the RMP (Risk Management Plan)
    • Who, when, what and how.
  • Life cycle of the safety concerns in RMPs: not all risks are created equal
  • Review of the list of safety concerns according to the GVP V Rev.2 module
  • Examples from renewal assessment reports
  • Review of safety concerns: RMP and PSUR, align or not align?
  • Safety concerns in RMP and PSUR: from theory to practice
  • Breakout sessions and interactive discussion of the results
  • Assessment and review of key concepts

MODULE 4 | 9 October 2024
Pharmacovigilance Documents – Focus on the Periodic Safety Update Report  (PSUR)

“The life beyond submission 2: The PSUR (Periodic Safety Update Report)”

  • Focus on PSURs: requirements, structure and content
  • Breakout sessions and interactive discussion of the results
  • RMPs and PSURs: things to consider
  • Assessment and review of key concepts

MODULE 5 | 16 October 2024
Pharmacovigilance Documents – Focus on the Periodic Safety Update Report  (PSUR)

“The life beyond submission 3: The PSUR, again”

  • PSUR writing: challenges and pitfalls
  • Document assessment and evaluation
  • Experience from PSUR authority assessment reports: what really matters
  • Preparation for the role playing: “plan, plan, plan…!”
  • Role play: design your own PSUR
  • Assessment and review of key concepts

MODULE 6 | 23 October 2024
Pharmacovigilance Documents – Focus on Addendum to the Clinical Overview (AddCO) and Referrals

“The Expected and the Unexpected: AddCOs and Referrals”

  • The Addendum to the Clinical Overview : an important milestone
    • From the Module 2.5 to the AddCo
    • Breakout sessions and interactive discussion of the results
  • The Referral: the worst Pharmacovigilance nightmare…?
    • What could happen
    • What has happened
    • What should happen
  • Breakout sessions and interactive discussion of the results
  • Assessment and review of key concepts
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