Detailed Syllabus & Weekly Breakdown

Module 1: The RWD Ecosystem & Data Sources (Weeks 1–4)

• Week 1: Introduction to RWD/RWE: Definitions and the paradigm shift from Randomized Clinical Trials (RCT) to RWE; The 21st Century Cures Act.
• Week 2: Data Repositories: Deep dive into Electronic Health Records (EHR), Pharmacy & Insurance Claims data, and Patient Registries.
• Week 3: Digital Health Data: Leveraging data from wearables, mobile apps, and Patient-Reported Outcomes (PROs).
• Week 4: Data Quality & Privacy: Assessing data "Fitness-for-Use"; Understanding HIPAA, GDPR, and data de-identification techniques.

Module 2: RWE Study Design & Analysis (Weeks 5–8)

• Week 5: Study Designs: Observational studies, Retrospective vs. Prospective cohorts, and Case-Control studies.
• Week 6: The "Estimand" Framework in RWE: Defining the target population and handling intercurrent events in real-world settings.
• Week 7: Statistical Methods: Propensity Score Matching (PSM) and techniques to minimize "Bias" and "Confounding" in non-randomized data.
• Week 8: Tooling for RWE: Introduction to the OMOP Common Data Model (CDM) and tools for large-scale data harmonization.

Module 3: Regulatory Impact & Market Access (Weeks 9–12)

• Week 9: FDA & EMA Guidelines: Reviewing recent guidance on using RWD for drug approvals and label expansions.
• Week 10: RWE for Market Access: How payers use RWE for pricing, reimbursement, and Health Technology Assessment (HTA).
• Week 11: Safety & Pharmacovigilance: Using RWD for long-term safety monitoring and signal detection (The Sentinel System).
• Week 12: Capstone Project: Developing a "Real-World Evidence Generation Plan" for a post-marketing safety or efficacy requirement.

Learning Outcomes

• Source Identification: Distinguish between different RWD sources and evaluate their validity for specific research questions.
• Methodological Rigor: Design observational studies that minimize bias and satisfy regulatory "Substantial Evidence" requirements.
• Regulatory Navigation: Interpret FDA and EMA frameworks for the successful submission of RWE.
• Value Communication: Present RWE findings to stakeholders (Payers/Providers) to support drug value and market access.

Assessment Weightage

Assessment Type	Weightage
Data Sourcing & Quality Quiz	20%
Study Design Proposal	30%
Critical Appraisal of a Published RWE Study	20%
Final RWE Generation Plan (Capstone)	30%