RWE PRACTICE COURSE

TARGETS : MSL
OBJECTIVES : Understanding & Application of RWE
TIME: 2 Hours *6 Times

Module 1 : INTRODUCTION

⦁ Definitions of Real-World Data and Real-World Evidence
⦁ Regulation Review 

Module 2 : Current Use of RWD for Evidence Generation

⦁ Generating Evidence Regarding Safety and Effectiveness
⦁ Trials Generating RWE
⦁ Trial Designs Using RWD to Generate Evidence
   - Randomized Controlled Trials Integrated into Health Care Systems
   - Observational Studies Using RWD to Generate RWE

Module 3: Framework for Evaluating RWD/ RWE for Use in Regulatory Decisions (1) 

⦁ Using Trials or Studies with RWD/RWE for Effectiveness Decisions
⦁ Assessing Fitness of RWD for Use in Regulatory Decisions
- Assessing Data Reliability (Data Accrual and Data Assurance) and Relevance
- Addressing Gaps in RWD Sources

Module 4 : Framework for Evaluating RWD/ RWE for Use in Regulatory Decisions (2) 

⦁ Potential for Study Designs Using RWD to Support Effectiveness
- Randomized Designs Using RWD
- Non-randomized, Single Arm Trials with External RWD Contro
- Observational Studies

Module 5 : Framework for Evaluating RWD/ RWE for Use in Regulatory Decisions (3) 

⦁  Regulatory Considerations for Study Designs Using RWD
- Use of Electronic Source Data
⦁ Regulatory Considerations for Clinical Studies Generating RWE‌
‌⦁ Data Standards — Appropriate Data Standards for Integration and Submission to Regulatory Agency

Module 6 : Stakeholder Engagement

⦁ Review & Discussion
⦁ Stakeholder Engagement & Support 

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