Regulatory course
Real-World Evidence for Market Access and Regulatory Strategy
Unlock the power of real-world evidence to drive access and approval. This focused one-day course gives you the tools to generate and apply RWE that meets the needs of both regulators and payers.
Dates and booking
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Who it’s for
Is this course for you?
Who should attend?
This course is designed for professionals involved in the generation, interpretation, and application of real-world evidence to support regulatory and market access strategies, including:
- Health Economics and Outcomes Research (HEOR) professionals
- Medical Affairs teams
- Regulatory Affairs specialists
- Market Access and Reimbursement managers
- Clinical Development professionals working on post-approval or observational research
- Anyone responsible for evidence generation, value demonstration, or HTA submissions
What you’ll learn
About this course.
Course Description
Real-world evidence (RWE) is no longer a "nice to have." It is now a core requirement for regulatory and market access success. As regulators and payers increasingly turn to data from everyday clinical practice to assess the safety, effectiveness, and value of new therapies, industry professionals must be equipped to navigate this evolving landscape.
This in-depth one-day course gives HEOR professionals, medical affairs teams, regulatory specialists, and market access managers a practical framework for generating and applying real-world evidence that supports approvals, reimbursement, and strategic positioning. You will explore the full range of real-world data (RWD) sources, including electronic health records, claims databases, registries, patient-reported outcomes, and digital health technologies, and understand how to assess their suitability for different objectives.
The course also covers key methodological approaches, from observational study design to data quality assessment and bias mitigation. You will gain insights into how regulatory agencies such as the FDA and EMA evaluate RWE in the context of submissions and approvals, as well as how HTA bodies and payers use RWE to inform pricing and access decisions.
Through real-world case studies and interactive discussions, you will learn how to design, interpret, and present RWE that meets the expectations of both regulators and payers. Whether you are developing a value dossier, preparing a regulatory submission, or building an evidence package to support pricing negotiations, this course will equip you with the knowledge and confidence to deliver credible and impactful RWE.
Learning objectives
By the end of this course, participants will:
- Describe the types of real-world data used in healthcare decision-making
- Recognise basic methodological approaches for generating RWE
- Understand how regulators and payers are currently using RWE to inform their assessments
- Reflect on how RWE might support regulatory submissions or market access strategies in their own context
- Identify key considerations and potential limitations when working with RWD
Programme highlights
- Introduction to real-world data (RWD) sources commonly used in regulatory and market access settings
- Overview of study designs and practical considerations when generating real-world evidence (RWE)
- Discussion of how regulatory bodies and HTA agencies are incorporating RWE into decision-making
- Case examples illustrating the use of RWE in submissions and value communications
- Group discussions on common challenges and strategies for cross-functional alignment
- Interactive sessions to reflect on how RWE can be applied within participants’ own roles
Good to know
Questions about this course.
Can I book for several colleagues?
Yes. Choose the number of participants next to a date. For a group of 4 or more, an in-house session tailored to your SOPs may suit you better.
What if I need to cancel?
Cancelling more than 30 calendar days before the course is free of charge. Between 21 and 30 days before, 50% of the fee is due, and the full fee within 21 days. A €50 administration fee applies per cancellation. You can also send a colleague in your place by letting us know in writing.
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