The 42nd ISPE Annual Meeting brings together researchers, regulators, industry experts, and academics to discuss drug safety, real-world evidence, and healthcare outcomes, with a strong focus on improving public health through data-driven research and collaboration.
VAC4EU will be there with an exhibition booth and extensive presence in the scientific programme including contribution to a course, two symposia as well as several oral presentations and posters.
Exhibition: Booth #107
📅 29 Aug – 2 Sept
📍Exhibit Hall, #107
🗣️ Fabio Riefolo, Alba Ortega Flores, Taylor Brown, Ashton Babcock
Throughout the conference, representatives from the VAC4EU Secretariat and Business Development teams will be available at booth #107. Stop by for a cup of coffee, learn more about the network, discuss potential collaborations, pick up some swag, or simply say hello! We would be very happy to see you there.
Course: Intermediate/Advanced Topics in Vaccine Safety and Effectiveness
⏱️ 14:30 – 18:00
📅 Sunday, 30 August
📍Amber 1+2, Level 2
🗣️ Miriam Sturkenboom
On Sunday afternoon, VAC4EU President Miriam Sturkenboom will contribute to the intermediate/advanced course on vaccine safety and effectiveness. Her session will focus on emerging topics and methods in vaccine safety assessment, including rare adverse events of special interest, self-controlled designs and target trial emulation, with an emphasis on moving beyond temporal associations towards causal, absolute and contextual risk assessment.
Lightning: Validation of Algorithms for the Identification of Myocarditis and Pericarditis in Real-World Data to Evaluate the Safety of the Pfizer-BioNTech COVID-19 Vaccine (COMIRNATY): A Post-authorisation Safety Study in the VAC4EU Network
⏱️ 10:30 – 10:35
📅 Monday, 31 August
📍Space 3, Level 0
🗣️ Amirreza Dehghan Tarazjani
The lightning sessions will kick off on Monday, starting with three panels focused on methods. Amirreza Dehghan Tarazjani (VAC4EU and UMCU) will participate in the third one, ‘Know Your Data & Validate.’ The session will cover results from a VAC4EU validation study assessing how accurately real-world data algorithms identify myocarditis and pericarditis in a retrospective post-authorisation safety study of the Pfizer-BioNTech COVID-19 vaccine.
Monday Poster Session
⏱️ 12:00 – 13:30
📅 Monday, 31 August
📍Exhibit Hall
In this first poster presentation session, attendees can see three VAC4EU posters covering case validation, semantic harmonisation, diagnostic code lists, and more.
- How good is a Large Language Model in a validation study? Application to a screening phenotype for myocarditis using hospital discharge records validated with medical charts in the VAC4EU SeValid project (Giulia Hyeraci, et al)
- A Semantic Harmonisation Workflow for Multinational Vaccine Studies: The VAC4EU CodeMapper Approach (Sima Mohammadi, et al)
- Developing Sensitive Diagnostic Codelists Using Clinician Interviews: A Methodological Framework Illustrated by Myocarditis within the VAC4EU Sevalid study (Sima Mohammadi, et al)
Symposium: Data Are Not Enough – Communication Practices for Pharmacoepidemiologists in a Complex Information Ecosystem
⏱️ 17:15 – 18:45
📅 Monday, 31 August
📍Space 2, Level 0
🗣️ Debabrata Roy
Monday evening, Debabrata Roy (DSRU) will contribute to a symposium dedicated to communication practices. The symposium will seek practical guidance and best practices for communicating real-world evidence, bringing a behavioural science perspective to the issue alongside pharmacoepidemiological and other expertise.
Debs’ talk, entitled “Beyond the Study Report: The Pharmacoepidemiologist’s Role in Evidence Stewardship,” will explore how pharmacoepidemiologists can help maintain the integrity and interpretability of real-world evidence, and support its appropriate communication, as findings move beyond the study report.
Symposium: Identify, Quantify and Act: Advancing Methods for Reducing Bias from Measurement Error
⏱️ 17:15 – 18:45
📅 Monday, 31 August
📍Amber 1+2, Level 2
🗣️ Rosa Gini, et al
Also on Monday evening, Rosa Gini (ARS) will contribute to another symposium detailing findings from a 2025 workshop which brought together a diverse group of researchers to address measurement error. The purpose of the symposium is to identify key challenges and explore recent innovation in the field, contributing to the future of RWD validation.
Rosa’s session, entitled “Quantify Measurement Error,” will highlight opportunities emerging from AI tools to improve study variable validations. She will introduce the component strategy that leverages RWD diversity in multidatabase studies to quantify the share of true positives missed by phenotypes.
Lightning: Results from the Vaccine Monitoring Collaboration for Europe (VAC4EU) post-authorisation safety study for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty®) in Europe
⏱️ 08:20 – 08:25
📅 Tuesday, 1 September
📍Space 3, Level 0
🗣️ Alejandro Arana
Tuesday’s programme will feature three mini sessions dedicated to safety and effectiveness, including a panel for the final verdict on the COVID-19 vaccines. Alejandro Arana (RTI-HS) will present results from the VAC4EU network in this panel, each covering Pfizer-BioNTech COVID-19 vaccine safety.
Lightning: Interim results from Post-Authorisation Safety Study (PASS) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) Bivalent/Omicron BA.1 and BA.4-5 in Europe: A study in the VAC4EU network
⏱️ 08:30 – 08:35
📅 Tuesday, 1 September
📍Space 3, Level 0
🗣️ Constanza Andaur Navarro
Constanza Andaur Navarro (UMCU) will also contribute to the panel on the COVID-19 vaccines, presenting interim results from the Pfizer-BioNTech Bivalent/Omicron COVID-19 vaccine.
Tuesday Poster Session
⏱️ 11:30 – 13:00
📅 Tuesday, 1 September
📍Exhibit Hall
In the second poster presentation session, attendees can see 8 posters covering results, tools or workflows from the VAC4EU network or studies in which VAC4EU is a contributing partner:
- RWD-FIT: A Tool for Standardised Data Source Evaluation (Christina Read, et al)
- Identifying Flares of 10 Autoimmune Diseases in Electronic Healthcare Data: Operational Algorithms and Background Incidence Rates from 10 Pan-European data sources (Fabio Riefolo, et al)
- Immunocompromised Status Definition in Observational Studies using Electronic Health Records: A Scoping Review and a Proposal for a Phenotype Identification Algorithm (Judit Riera, et al)
- Estimating sensitivity of a highly specific algorithm for myocarditis using a sensitive screening algorithm: results from the VAC4EU SeValid project (Rosa Gini, et al)
- Interpreting measurement error in multi-database studies using the Component Algorithm Strategy: analysis of three clinical outcomes across four diverse data sources from the VAC4EU network (Paolo Pricoco, et al)
- Assessing the Impact of different data prompts on the identification of ulcerative colitis patients, time to cohort entry and occurrence of flares in four European healthcare data sources: the Component Algorithm Strategy (Giuseppe Roberto, et al)
- Maternal ABRYSVO vaccination in the VAC4EU European network: National recommendations and early uptake patterns (Vjola Hoxhaj, et al)
- The utilisation of antiseizure medications in pregnant women, and women and men of childbearing potential (ADEPT): a multi-database study from 6 European countries (Shahab Abtahi, et al)
Wednesday Poster Session
⏱️ 12:00 – 13:30
📅 Wednesday, 2 September
📍Exhibit Hall
The final poster session also includes VAC4EU results with a poster detailing myocarditis outcomes following vaccination with the Pfizer-BioNTech COVID-19 vaccine:
- Natural History and Clinical Outcomes of Myocarditis and Pericarditis Following Pfizer-BioNTech COVID-19 Vaccine (Comirnaty): A Multi-Database European Post-Authorisation Safety Study (PASS) in the VAC4EU network (Sima Mohammadi, et al)
We are very much looking forward to seeing you in Milan!