In this free webinar we will explore the evolving global guidelines and frameworks on the use of real-world data/evidence (RWD/E) in regulatory decision-making and health technology assessments (HTA).
TORONTO, Aug. 7, 2024 /PRNewswire-PRWeb/ -- Real-world data (RWD) and real-world evidence (RWE) 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 frameworks surrounding the use of RWD in these critical processes, common "best practices" across these guidelines, and topics on which additional guidance is needed.
This webinar aims to familiarize participants with these published guidelines and frameworks focusing on the following key discussion points:
1) Regulatory guidance focusing on the following:
- United States: Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
2) Guidance published by select HTA bodies:
- United Kingdom (National Institute for Health and Care Excellence [NICE])
- Canada (Canadian Agency for Drugs and Technologies in Health [CADTH])
- Australia (Pharmaceutical Benefits Advisory Committee [PBAC])
3) Other guidelines and frameworks published by thought leaders and trade organizations
4) Common "best practices" across guidelines and key operational and methodological topics for which more detailed guidance and alignment within and between regulatory agencies and HTA bodies is needed
Register for this webinar today to understand the practical application of RWD and RWE in regulatory decision-making and health technology assessments.
Join experts from Anlitiks, Stephanie Butler, PharmD, Principal Practice Lead; and Kitty Rajagopalan, PhD, President & Chief Scientific Officer, for the live webinar on Thursday, August 29, 2024, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Global Evolution of Real-World Data and Real-World Evidence in Regulatory Approval and Health Technology Assessments.
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