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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