MODULE 1 | 13 September 2023
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 | 20 September 2023
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)
- 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 | 26 September 2023
Pharmacovigilance Documents – Focus on the Risk Management Plan (RMP)
“The life beyond submission, 1: Risks and Plans”
- Focus on the RMP (Risk Management Plan)
- 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 | 28 September 2023
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 | 11 October 2023
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 | 18 October 2023
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
Professionals involved in the planning, preparation, coordination and review of aggregated safety reports.
In particular:
Drug Safety and Pharmacovigilance department, Regulatory Affairs department and Quality and Compliance department (e.g. medical writers, pharmacovigilance writers, pharmacovigilance officers, pharmacovigilance managers, QPPVs, safety physicians, managers regulatory affairs and medical evaluators/advisors, document quality and compliance managers).
Participant experience
Basic knowledge of drug development and pharmacovigilance.
Presentation, hands-on exercises, group, and class discussions with a limited number of attendees.
