• views: 54
• date: 18 November 2025
• posted by: voska89

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 the EU 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
Homepage
https://www.udemy.com/course/joint-clinical-assessment-eu-jca/




   
   
   

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