Explores pharmacovigilance in healthcare settings and role of healthcare professionals. 
Ideal for enhancing clinical practice knowledge.

08:30 - 09:30 Introduction: Place of HCPs in the system / Angela Caro
09:30 - 10:30 Human factors and safety of medicines and devices / Angela Caro and Brian Edwards

11:00 - 12:00 Medication errors and Medication Safety Officer / Loubna Alj
12:00 - 12:45 Spontaneous reporting / Monica Tarapues and Alem Zecarias
12:45 - 13:00 Questions and Answers

14:00 - 15:00 The Role of Pharmacoepidemiology and Real-World Studies in Pharmacovigilance / Saad Shakir
15:00 - 16:00 Managing risks around medicines and vaccines in clinical practice / Mark Perrott

16:30 - 16:55 ISoP-SIG Pharmacovigilance in the Community / Mohamed A. Elhawary
16:55 - 17:00 Conclusion / Alem Zecarias

09:00 - 10:00 Welcome Remarks
Inspection vs. Auditing: Strengthening PV Compliance

• Differences & Common Findings in Audits vs Inspections 
• Preparing for Regulatory Inspections & Industry Best Practices
• Case Studies: Lessons Learned from Recent Inspections

Speakers:
Mayada Alkhakany (Baghdad Heart & National / Health Factory – Iraq)
Santiago Schiaffino (AstraZeneca, Spain)

10:00 - 11:00 Quality of Safety Information Governance

• Quality Management for Real-World Evidence in Pharmacovigilance
• Governance of AI in Pharmacovigilance

Speakers:
Deborah Layton (Lane Clark & Peacock – United Kingdom)
Santiago Schiaffino (AstraZeneca – Spain)

11:30 - 12:30 Medical Literature Review & Its Impact on Signal Detection

• Challenges in Identifying Signals from Literature Data
• AI-Powered Literature Review for PV
• Best Practices for Integrating Literature into Signal Management

Speakers:
Nicole Baker (biologit – Republic of Ireland)
Deborah Layton (Lane Clark & Peacock – United Kingdom)
Ban Abdul Ameer (Iraq Pharmacovigilance Center – Iraq)

12:30 - 13:30 Risk Minimization Measures: From Challenge to Opportunity

• RMP: Innovations in Risk Mitigation Strategies
• Measuring the Effectiveness of Risk Minimization Plans
• Case Study: Transforming Regulatory Challenges into Business Opportunities

Speaker:
Dr Thamir Alshammari (WHO consultant, WHO Vaccine Advisory Member)

14:30 - 15:30 Crisis Management in Pharmacovigilance

• Handling Emerging Safety Issues & Rapid Risk Communication
• Best Practices in Product Recall & Safety Alerts
• Learnings and process improvements after managing a safety crisis 

Speaker:
Dr Thamir Alshammari (WHO consultant, WHO Vaccine Advisory Member)
15:30 - 16:30 Future of Pharmacovigilance: Leveraging Innovation & Digital Transformation

• Emerging Trends & Regulatory Expectations

Speaker:
Felix Arellano (Roche – Switzerland)

17:00 - 17:30 Interactive Case Study & Closing Remarks

• Practical Scenario: speed auditing 
• New ISOP group: Industry Community
• Discussion & Wrap-up

Speakers:
Maria Bantouna (Bristol Myers Squibb – Switzerland)
Santiago Schiaffino (AstraZeneca – Spain)
Joanne Holley (Esteve – Berlin)

Health care Professionals from Pharmacovigilance centres, Immunization programmes, Regulatory agency

09:00 - 11:00 Introduction to pharmacovigilance of vaccines: Key concepts and international frame

• 09:00 - 09:30 1. Definition and importance of pharmacovigilance of vaccines / Ghita Benabdallah
• 09:30 - 10:00 2. AEFI &AESI : Classification / Houda Sefiani
• 10:00 - 10:40 3.Overview of stakeholders involved in immunization safety and pharmacovigilance of vaccines / Rebecca Chandler
• 10:40 - 11:00 General discussion

11:30 - 13:30 Bridging tools for vaccine safety: MedDRA and Brighton collaboration

• 11:30 - 12:10 Brighton definitions: Strengthening the evaluation of AEFI / Miriam Strurkenboom
• 12:10 - 12:50 Harmonizing vaccine safety: Applicability of Brighton definitions for safety surveillance and background rates: / Andy Stergachis
• 12:50 - 13:20 MedDRA in Support of Pharmacovigilance / Heba Ibrahim
• 13:20 - 13:30 General discussion

14:30 - 16:30 AEFI investigation and causality assessment: strengthening evidence for vaccine safety

• 14:30 - 15:00 AEFI investigation / Ghita Benabdallah
• 15:00 - 15:30 WHO Causality assessment of AEFI / Houda Sefiani
• 15:30 - 16:30 Working Groups: investigation and causality assessment of a real case / Ghita Benabdallah, Houda Sefiani, Rebecca Chandler

16:45 - 17:30 Panel of discussion: AEFI management during health crisis

• 16:45 - 17:15 AEFI surveillance and communication in health crisis: preparedness strategies / All speakers
• 17:15 - 17:30 General discussion and Conclusion

Essential for Industry, regulators and public health

08:00 - 08:10 Welcome and introduction to the course / Gianluca Trifirò (Department of Diagnostics and Public Health, University of Verona - Verona, Italy)
08:10 - 08:55 Principles for Observational Real-World Studies including their Strengths and Weaknesses
Speaker: Saad Shakir (ADROITVIGILANCE - London, United Kingdom)
08:55 - 09:40 Data sources and study design
Speakers:
Gianluca Trifirò (Department of Diagnostics and Public Health, University of Verona - Verona, Italy)
Salvatore Crisafulli (Department of Diagnostics and Public Health, University of Verona - Verona, Italy)

10:10 - 11:10 - Sources of bias and confounding
Speakers:
Gianluca Trifirò (Department of Diagnostics and Public Health, University of Verona - Verona, Italy)
Salvatore Crisafulli (Department of Diagnostics and Public Health, University of Verona - Verona, Italy)

11:10 - 12:00 Role of Observational Data in Regulatory Decision Making: The Drug Safety Paradigm
Speaker: Tarek Hammad (Takeda Development Center Americas, Inc. - Cambridge, Massachusetts, USA)

Professionals in the pharmaceutical industry and regulatory agencies with basic to intermediate familiarity with BRA​

13:00 - 13:10 Welcome & Set-up

• Why structured BRA matters for transparency, traceability, and decision readiness.
• Overview of frameworks used today

Speaker: Adel Abou Ali (VP, Global Risk Management & REMS, Syneos Health - Illinois, United States)

13:10 - 13:40 Regulatory Landscape: What “Good” Looks Like

• ICH Recommendations and Implications
• FDA Benefit–Risk Framework
• EMA Adoption of BR Approaches
• Comprehension Checkpoint

​Speaker: Tarek Hammad (VP & Head, Plasma-Derived Therapy & Marketed Products, Takeda - Maryland, United States)

13:40 - 14:10 Methods Primer (with live demo)

• BRAT vs. PrOACT-URL: steps, artifacts, pros/cons; MCDA/qBRA.
• Visual tools: Value trees, effects tables, weighting, and sensitivity.
• Comprehension Checkpoint.

Speaker: Adel Abou Ali (VP, Global Risk Management & REMS, Syneos Health - Illinois, United States)

14:10 - 15:10 Hands-On Lab 1: Build the Framework 

• Exercise A - VALUE TREE: Understand BRA context and decision question, draft appropriate value tree (for a marketed product)
• Checkpoint: Are we considering all “key” benefits and risks?

Lead: Uwe Niehaus (Founder & Managing Director of BPI Learn - Madrid, Spain), All faculty 

15:40 - 16:45 Hands-On Lab 2: Build the Framework

• Exercise B – Effects table: Building/interpretation of an effects table and finalizing the value tree
• ​Exercise C – BRA outcome & communication: Determinate BRA outcome, and selecting regulator-ready narrative BRA document
• Checkpoint: Is the key BRA question well addressed?
• ​Checkpoint: Is our evidence decision-adequate?

Lead: Uwe Niehaus (Founder & Managing Director of BPI Learn - Madrid, Spain) / All faculty

16:45 - 17:15 Panel Q&A Take-Home Kit

• AI on BRA: emerging applications and potential impact - Uwe
• ​Panel Q&A – All Faculty