Joint Clinical Assessment (EU) - JCA
Published 11/2025
Duration: 4h 1m | .MP4 1280x720 30fps(r) | AAC, 44100Hz, 2ch | 1.76 GB
Genre: eLearning | Language: English
Market Access | Regulatory Affairs | HEOR | RWE | HTA | Health Economics | Pharma
What you'll learn
- Map and architect JCA-ready PICOs and EU comparator strategies that reflect real-world SoC.
- Design pivotal evidence "fit for JCA" (H2H, pragmatic, external control) using estimands you can defend.
- Execute Bucher/NMA/MAIC/STC with proper assumptions, diagnostics, and pre-planned sensitivity ladders.
- Build target-trial RWE with robust confounding control and full provenance for replication.
- Operationalize outcomes, surrogates, PROs/HRQoL (MIDs, TTD) and safety (AESIs/EAIRs) for decision-grade interpretation.
- Author a reproducible JCA dossier (tables, figures, traceability index, D-series code bundle) that assessors can rerun.
- Convert JCA to national P&R: absolute effects, rebuttal kits, pricing/MEAs, tenders-under a war-room, RACI, risk & QA model.
Requirements
- No requirements
Description
Disclaimer: This course contains the use of AIThis advanced, practice-first course is a complete playbook for succeeding under theEU Joint Clinical Assessment (JCA)from 2025 onward. You'll learn how to design, defend, and deploy comparative-effectiveness evidence that survives EU-level scrutiny and can be reused-without re-analysis-by Member States for national pricing and reimbursement. We start by demystifying governance, waves, and transition, then move into the operational core: scoping PICOs and mapping standards of care across Member States; building a comparator strategy (including individualized "doctor's-choice" bundles); and engineering pivotal evidence fit for JCA-head-to-head trials, pragmatic elements, and disciplined external-control designs.
You'll master indirect comparisons (Bucher, NMA, MAIC/STC), target-trial RWE with audit-ready provenance, and the "tricky stats" that regularly derail submissions (crossover, missing data, multiplicity, immature OS, and HTE). Outcomes, surrogates, PROs/HRQoL (instruments, MIDs, cross-walks), and safety (MedDRA/CTCAE, AESIs, EAIRs) are taught with a focus on patient relevance and interpretability.
On the authoring side, you'll build a JCA-aligned dossier with evidence tables, traceability, and a small, high-signal figure set that assessors can rerun from your code bundle. Then you'll translate the JCA into national action: absolute effects, divergence handling, rebuttal kits, pricing/MEAs, and tenders (MEAT/BPQR). Finally, you'll operationalize the work: a readiness RACI across global-regional-affiliate, a "war-room" model with SLAs, a risk register, comment tracker, vendor pod strategy, layered QA, and a living playbook for annual refresh.
Designed for Market Access, HEOR, RA, Clinical, Biostats, and Medical Writing leaders, the course ships with templates, checklists, and code-ready figure scripts so you can execute immediately-end to end-from PICO to price.
Who this course is for:
- Designed for Market Access, HEOR, RA, Clinical, Biostats, and Medical Writing leaders
More Info
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