About the ISPE European Meeting
The International Society for Pharmacoepidemiology (ISPE) ↗ European Annual Meeting is a 3-day scientific conference focused on drug utilisation, pharmacovigilance, and real-world evidence methodology. The 2027 edition takes place in Amsterdam — a fitting location given the Netherlands' strong tradition of pharmacoepidemiology and the proximity of the European Medicines Agency (EMA) ↗ headquarters in Amsterdam.
Key stakeholders include researchers from the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) ↗, the DARWIN EU ↗ regulatory science infrastructure, and the European Health Data and Evidence Network (EHDEN) ↗.
Scientific tracks (2027)
EMA's DARWIN EU ↗ as a regulatory RWE infrastructure; fit-for-purpose RWE studies for post-marketing requirements; PASS and PAES study design under the EMA PASS guidance ↗.
Methods for designing observational studies to emulate RCTs — counterfactual frameworks, estimands, active comparator new-user designs. Applications from the Hernán & Robins target trial emulation framework (NCBI) ↗.
Disproportionality analysis in EudraVigilance ↗ and WHO VigiBase ↗; SCCS, case series, and near real-time surveillance for vaccine and drug safety.
EU Joint Clinical Assessment (EU-HTA Regulation 2021/2282) implementation; PICO framework for HTA dossiers; network meta-analysis; indirect treatment comparisons. EUnetHTA 21 methods guidance. EMA–HTA collaboration ↗.
OMOP CDM adoption across European data networks; EHDEN OMOP mapping ↗; FAIR (Findable, Accessible, Interoperable, Reusable) principles for health data under the European Health Data Space (EHDS) ↗.
AI/ML for confounding control (propensity scores, HDPS), natural language processing for EHR phenotyping, federated learning across data networks. Validation requirements for ML-derived safety signals. Pharmacoepidemiology & Drug Safety journal ↗.
The European pharmacovigilance system
The EU pharmacovigilance framework is established under Directive 2010/84/EU and Regulation 1235/2010 ↗, administered by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) ↗.
EudraVigilance
The European database of suspected adverse drug reaction reports. Contains ~30 million reports from 50+ countries. Public access via the ADR Reports portal ↗. Signal detection is performed using EVDAS (EudraVigilance Data Analysis System) with Bayesian methods (IC025) and frequentist disproportionality (PRR, ROR).
PRAC signal evaluation
PRAC meets monthly to review safety signals from EudraVigilance, published literature, and company-submitted PSURs. Recommendations can include label updates, DHPC letters, PASS requirements, or market suspension. All PRAC meeting minutes and outcomes are published on EMA's PRAC page ↗.
DARWIN EU
EMA's real-world evidence service, launched 2022. Provides rapid, fit-for-purpose studies using EU health data from 30+ data sources across 10 member states. Supports regulatory decisions including benefit-risk assessments and HTA. All protocols and results are published. DARWIN EU study catalogue ↗.
European pharmacoepidemiology data sources
| Database | Country | Type | Approx. records |
|---|---|---|---|
| CPRD ↗ | UK | Primary care EHR | ~60M patients |
| SIDIAP ↗ | Spain (Catalonia) | Primary care + dispensing | ~7M patients |
| GePaRD | Germany | Health insurance claims | ~20M insured persons |
| NIVEL-PCD ↗ | Netherlands | Primary care EHR | ~1.8M patients |
| Health-Searchdb (HSD) | Italy | Primary care EHR | ~1.5M patients |
| Danish National Registers ↗ | Denmark | National linked registers | Full population (~6M) |
OMOP CDM harmonisation across these networks is coordinated by EHDEN ↗ and the OHDSI community ↗.
Frequently asked questions
What is ISPE and the European Annual Meeting?
ISPE (International Society for Pharmacoepidemiology) is the leading global organisation for pharmacoepidemiology — the science of studying drug use and effects in large human populations. The European Annual Meeting is the continent's premier forum for real-world evidence (RWE), pharmacovigilance methods, drug safety, and health technology assessment (HTA). It typically attracts 600–900 specialists from academia, regulatory agencies (EMA, national competent authorities), HTA bodies, and industry.
What is pharmacoepidemiology and how does it differ from clinical trials?
Pharmacoepidemiology studies drug effects using observational data from real-world populations — electronic health records, claims databases, registries, and wearable devices. Unlike RCTs, pharmacoepidemiological studies capture rare adverse events, long-term outcomes, and use in patient populations often excluded from trials. Key designs include cohort studies, case-control studies, self-controlled case series (SCCS), and target trial emulation.
What is the EMA's role in pharmacovigilance in Europe?
The European Medicines Agency (EMA) coordinates pharmacovigilance across EU member states. Key systems include EudraVigilance (the European adverse drug reaction database), PSUR (Periodic Safety Update Reports), and PASS (Post-Authorisation Safety Studies) requirements. EMA also convenes the Pharmacovigilance Risk Assessment Committee (PRAC), which assesses safety signals and recommends regulatory action.
What database infrastructures support European pharmacoepidemiology?
Major European data networks include the DARWIN EU initiative (regulatory RWE at EMA), the EHDEN network (OMOP-standardised EHR data across 30+ data partners), the ENCePP network (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance), and national databases such as CPRD (UK), SIDIAP (Spain), and GePaRD (Germany).
Is the ISPE European Meeting open to non-members?
Yes. Non-members can register for the meeting, though ISPE members receive a registration discount. Membership categories include Full Member, Associate Member (early career), and Institutional Member. Abstract submission and trainee-specific sessions are open to all registrants. See ispe.pharmacoepi.org for registration details.