Programme

Parallel training courses

Course 1:
Pharmacovigilance in the Community and Healthcare
Explores pharmacovigilance in healthcare settings and role of healthcare professionals.
Ideal for enhancing clinical practice knowledge.

Course Coordinator:
Alem Zekarias (UMC, Sweden)

Course 2:
Advanced Course in Pharmacovigilance for the Industry
Aimed at PV professionals. Explores how to advance PV practice with the rapidly changing requirements.
Perfect for advancing industry expertise.

Course Coordinators:
Mayada Alkhakany (Chair of ISoP Pat-EG SIG & ISoP Board Member, Iraq)

Santiago Schiaffino (Senior Director, Patient Safety Biopharma at AstraZeneca, Spain)

Course 3:
Challenges and strategies for strengthening Pharmacovigilance of Vaccines

Essential for Pharmacovigilance centers, Immunization Programs and public health.

Course Coordinator:
Ghita Benabdallah (ISoP Board Member, National Pharmacovigilance Center, Morocco)

Course 4 &5:
Pharmacoepidemiology and Benefit/Risk Assessment

Essential for Industry, regulators and public health

Course 4 Coordinator:
Gianluca Trifirò (, Professor of Clinical Pharmacology, University of Verona, Italy)

Course 5 Coordinator
Adel Abou Ali (Vice President & Strategy Lead for Global Risk Management and REMS at Syneos Health, USA)

Full Day training 8:30 -17:30

8:30- 9:00 Registration
9:00- 10:00 Role of HCPs in the PV
10:00- 11:00 Human factors and safety of medicines and devices
11:00- 11:30 Break
11:30 - 12:30 Medication errors and Medication Safety Officer
12:30- 13:30 Spontaneous reporting
13:30- 14:30 Lunch
14:30- 15:30 Risk Management
15:30- 16:30 Real world evidence, healthcare research and epidemiology with the PV community
16:30- 16:45 Break
16:45 - 17:30 Plenary session: What is the way forward?

Full Day training 8:30- 17:30

8:30 -9:00 Registration
9:00- 10:00 Inspection vs. Auditing: Strengthening PV Compliance
10:00 - 11:00 Quality of Safety Data: New Technologies for Enhancement
11:00- 11:30 Break
11:30- 12:30 Medical Literature Review & Its Impact on Signal Detection
12:30- 13:30 Risk Minimization Measures: From Challenge to Opportunity
13:30- 14:30 Lunch
14:30- 15:30 Crisis Management in Pharmacovigilance
15:30- 16:30 Future of Pharmacovigilance: Leveraging Innovation & Digital Transformation
16:30- 16:45 Break
16:45- 17:30 | Interactive Case Study & Q&A

Full Day training 8:30- 17:30

8:30 -9:00 Registration
Introduction to pharmacovigilance of vaccines
11:00- 11:30 Break
Adverse events following immunisation
13:30- 14:30 Lunch
Methods of analysis
16:30- 16:45 Break
Strategies and prioritises for strengthening pharmacovigilance of vaccines systems

Half Day training 8:30- 13:00

8:30 -9:00 Registration
9:00- 9:45 Principles for Observational Real-World Studies including their Strengths and Weaknesses
9:45 - 10:30 Data sources and study design
10:30- 11:00 Sources of bias and confounding
11:00- 11:30 Break
11:30- 12:15 Continue Sources of bias and confounding
12:15- 13:00 Role of Observational Data in Regulatory Decision Making: The Drug Safety Paradigm