2024 - Global Evolution of Real-World Data and Real-World Evidence in Regulatory Approval and Health Technology Assessments

Real-world data (RWD) and real-world evidence have emerged as essential tools for augmenting traditional clinical trials in regulatory decision-making and health technology assessments (HTAs). This webinar offers a comprehensive exploration of the evolving global guidelines and policies surrounding the use of RWD/real-world evidence in these critical processes.
In this webinar, the attendees will learn about best practices for generating high-quality real-world evidence that aligns with regulatory and HTA standards. Moreover, the speakers will explore real-world case studies that demonstrate the successful integration of RWD/real-world evidence into regulatory and HTA processes, offering practical insights and lessons learned from these applications.
This webinar aims to equip participants with the necessary knowledge to effectively utilize RWD/real-world evidence in their regulatory strategies and decision-making processes and focuses on the following key discussion points:
A detailed examination of existing guidelines and frameworks for using RWD/real-world evidence in major regions
US Food and Drug Administration (FDA) guidance on RWD/real-world evidence for regulatory decision-making, including the 21st Century Cures Act and recent developments
European Medicines Agency (EMA) initiatives and guidance on RWD/RWE, including the data analysis and real-world interrogation network (DARWIN EU®)
Overview of RWD/real-world evidence policies in Asia (e.g., PMDA in Japan), Canada and Australia
The attendees will also get to learn how RWD/real-world evidence support regulatory submissions such as new drug applications and label expansions, contribute to post-market safety surveillance and inform HTA for reimbursement and pricing decisions.
The speakers will also cover how using RWD/real-world evidence can ensure the quality and reliability of data, address data privacy and ethical considerations and methodological considerations for robust analysis. Moreover, effective strategies for presenting real-world evidence to regulators and HTA bodies will be explored.
Register for this webinar today to understand the practical application of real-world data and real-world evidence in regulatory decision-making and health technology assessments.
Keywords: Real-World Data, Real-World Evidence, Clinical Data, Regulatory, HTA, Health Technology Assessment, HEOR, RWE, Commercialization/HEOR/Market Access, RWD