Courses, masterclasses, and audio companion courses in Real-World Evidence — designed for the professionals who need to use it, defend it, and build with it.
A unique conversational audio course companion to Real-World Evidence: Principles and Practice — where two world-class experts dissect every chapter in a format that makes the science genuinely engaging.
Bespoke, expert-led training designed for pharma, biotech, CRO, regulatory, and HTA teams. From a half-day introduction to a three-day methodology intensive — delivered in-person or online and tailored to your team's level and focus.
| Module | Key Topics | Format |
|---|---|---|
| T1.1What is Real-World Evidence? | RWE vs RCTs · Evidence pluralism · Applications in pharma, devices, HTA | Half-day |
| T1.2The RWE Ecosystem | Stakeholders · Data providers · Regulators · Ethical and legal context | Half-day |
| T1.3Where RWE is Used Today | FDA, EMA, MHRA · HTA and market access · Safety and effectiveness | Half-day |
| T1.4RWE Foundations — Full Day | T1.1 + T1.2 combined with applied case studies and interactive Q&A | Full day |
| Module | Key Topics | Format |
|---|---|---|
| T2.1Observational Study Design | Cohort, case-control, cross-sectional · Selection criteria · Comparative guidance | Half-day |
| T2.2Bias, Confounding & Causal Inference | Bias types · Propensity scores, IPTW, matching · Target trial emulation | Full day |
| T2.3Statistical Concepts for RWE | HR, OR, RR · Confidence intervals · Estimands · E-values | Full day |
| T2.4The RWE Study Lifecycle | Protocol development (HARPER) · Data extraction · Common pitfalls | Half-day |
| T2.5Critical Appraisal of RWE Studies | Appraisal checklist · Red flags · STROBE, RECORD, ISPE | Half-day |
| Module | Key Topics | Format |
|---|---|---|
| T3.1RWE in Regulatory Decision-Making | FDA 21st Century Cures · EMA post-authorisation · MHRA · Global case studies | Full day |
| T3.2PASS & Post-Market Requirements | GVP Module VIII · ENCePP · DARWIN EU · FDA post-market commitments | Full day |
| T3.3RWE for HTA & Market Access | NICE, HAS, G-BA, NCPE · Relative effectiveness · Common HTA pitfalls | Full day |
| T3.4Building a Regulatory RWE Programme | Evidence strategy framework · Lifecycle alignment · Risk mitigation | Half-day |
| T3.5Regulatory RWE Intensive | T3.1 + T3.2 + T3.3 with submission workshop and mock HTA dossier critique | 2.5 days |
| Module | Key Topics | Format |
|---|---|---|
| T4.1The RWD Landscape | EHR, claims, registries, biobanks, wearables, PROs · Fitness-for-purpose framework | Full day |
| T4.2Global RWD Ecosystems | US, EU, Asia-Pacific, LATAM · CPRD, SNDS, Optum, IQVIA · Cross-border access | Full day |
| T4.3Data Quality & Governance | Validation methods · DUAs · Privacy frameworks · OMOP, FHIR, Sentinel | Full day |
| T4.4Selecting & Procuring RWD | Vendor assessment framework · Contracting · Security · Use case mapping | Half-day |
| Module | Key Topics | Format |
|---|---|---|
| T5.1Evidence Strategy Planning | Lifecycle evidence needs · Design and data alignment · Evidence gap analysis | Full day |
| T5.2AI & Machine Learning in RWE | NLP, causal ML, LLMs · Opportunities and pitfalls · Regulatory perspective | Full day |
| T5.3Digital Health & RWE | Wearables · Digital biomarkers · Validated digital endpoints · Ethics | Half-day |
| T5.4The Future of RWE | Data federation · Synthetic data · AI study design · Precision medicine | Half-day |
| T5.5Building a Global RWE Programme | CoE models · People, processes, platforms · Governance · ROI measurement | Full day |
| T5.6RWE Leadership Summit (custom) | 2-day strategic workshop · Capability benchmarking · Roadmap facilitation | 2 days |
Online delivery available for all modules. Multi-event bookings (3+ per year) qualify for a 15% volume discount.
Enquire About Training →A 3-day strategic residency at the Château de Lailly-en-Val, Loire Valley — for senior pharma and healthcare leaders building the future of integrated evidence generation.