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 industry 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)

Course 1

Pharmacovigilance in the community and healthcare
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?
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Course 2

Advanced pharmacovigilance for the industry: Mastering Inspections, Data Quality & Risk Management in the Digital Age
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
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Course 3

Challenges and strategies for strengthening Pharmacovigilance of Vaccines
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
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Course 4

Introduction to pharmacoepidemiology
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
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Course 5

Benefit Risk Assessment
Half Day training 13:00- 17:30
  • Details soon
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18:30- 20:30    Welcome Reception 

 19:30- 20:30   Transportation from the conference venue to the dinner

  20:30- 23:30    Conference Dinner

23:30 – 24:00  Transportation back to the conference venue

Conference Dinner

Join us for that special dinner of ISoP 2025 Cairo.

Venue: Pyramids, Giza

Ticket sold at 50 USD 

Dress code: Smart casual

Transfer to and from dinner venue will be provided. 

Purchasing tickets is available for ISoP 2025 Cairo participants and accompanying persons here

 

For inquires contact us at [email protected] 

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10:00- 11:00

10:00- 11:00

S3- Parallel session: What’s new from North America and EU?

 
Chair:
Viola Macolic-Sarinic

Scientific adviser on safety of medicines at the European Medicines Agency (EMA), Netherlands

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10:00- 11:00

S3.1- Parallel session: What’s ne
 Viola Macolic-Sarinic

Scientific adviser on safety of medicines at the European Medicines Agency (EMA), Netherlands

S3.1- Parallel session: What’s ne

  10:00- 11:00

Viola Macolic-Sarinic

Scientific adviser on safety of medicines at the European Medicines Agency (EMA), Netherlands

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