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ISoP Mid-Year Symposium Barcelona 2024 Handouts
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Day 1 – Monday, June 3
Real-World Evidence (RWE)
Session 1.A | 09.00-09.10
Welcome and Introduction to the symposium
Session 1.B | 09.10-09.35
Use of Real-World Evidence in medicines regulation: how RWE is transforming regulatory decision making?
Session 1.C | 09.35-10.00
Harmonization of safety assessments of vaccines and medicines from SPEAC to VAC4EU/ConcePTION
Session 1.D | 10.00-10.25
Regulatory driven studies in the European landscape
Questions and discussion | 10.25-10.30
Session 2.A | 11.00-11.25
Real-World Data to improve pharmacovigilance: perspective from a regulatory agency
Session 2.B | 11.25-11.50
Using Real-World Data for signal validation and prioritisation: experiences from a European network study
Questions and discussion | 11.50-12.00
Session 2.C | 12.00-12.15
Abstract presentation: #40 TheShinISS-Vax: post-marketing active surveillance of the safety of COVID-19 and influenza vaccines in Italy
Session 2.D | 12.15-12.30
Abstract presentation: #55 A way towards reliable research: mapping data quality assessments in multi-database pharmacoepidemiologic studies
Session 3.A | 13.30-13.55
Ensuring appropriate quantitative signal detection: Routine Use, Challenges, and Industry Insights
Session 3.B | 13.55-14.20
The REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV): development and statement
Session 3.C | 14.30-14.40
Abstract presentation: #7 Using Real-World Data (RWD) for Rapid Safety Signal Assessment
Session 3.D | 14.40-14.50
Abstract presentation: #51 Antipsychotics and risk of relevant weight gain in naïve patients: a nested Case-Control study from the ICARO study
Questions and discussion | 14.50-15.00
Session 4.A | 15.30-15.55
Adapting to change through innovation and collaboration
Session 4.B | 15.55-16.20
ADR coding in pharmacovigilance: usefulness of generative AI and large language models
Session 4.C | 16.30-16.45
Abstract presentation: #17 Integrating Risk Minimization Measures of Medications into Hospital Information Systems: Insights from three Hospitals in Saudi Arabia
Session 4.D | 16.45-17.00
Abstract presentation: #25 Analysis of the teaching-learning process of pharmacovigilance in Portugal
Questions and discussion | 17.00-17.15
Day 2 – Tuesday, June 4
Primary care and clinical aspects of pharmacovigilance
Session 5.A | 09.00-09.40
The promise of pharmacogenomics: where are we now and where are we going?
Session 5.B | 09.40-10.00
Pharmacovigilance challenges in personalized medicine
Session 5.C | 10.00-10.20
The Yellow Card Biobank: Strengthening Pharmacovigilance through Pharmacogenomics
Session 5.D | 10.30-10.40
ISoP Fellowship – What is an ISoP fellow?
Session 6.A | 11.00-11.25
Pharmacovigilance and Patient Safety Strategy in Catalonia
Session 6.B | 11.25-11.50
Pharmacovigilance in Primary Care: Challenges and Opportunities
Session 6.C | 11.50-12.15
Antimicrobial Resistance and Pharmacovigilance – Mapping the Venn Diagram
Questions and discussion | 12.15-12.30
Session 7.A | 13.30-13.55
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally
Session 7.B | 13.55-14.20
Effectiveness of one dose of MVA-BN vaccine against mpox: a multicountry target trial emulation study
Questions and discussion | 14.20-14.30
Session 7.C | 14.30-14.45
Abstract presentation: #43 Integrating spontaneous reporting with real world data for signal detection processing: the example of acquired haemophilia A and COVID-19 Vaccines
Session 7.D | 14.45-15.00
Abstract presentation: #11 GP consultations for menstrual disorders after COVID-19 – a self-controlled cohort study based on routine healthcare data from the Netherlands
Session 8.A | 15.30-15.55
Pharmacovigilance in the age of fake news
Session 8.B | 15.55-16.20
How to improve the impact of communication in pharmacovigilance
Session 8.C | 16.20-16.45
Patient behaviour in response to medicine safety communications
Questions and discussion | 16.45-17.00
