History of Real-World Evidence Prior to the 21st Century Cures Act
Medical Affairs thought leaders discuss the Pre-21st Century Cures Act uses of Real World Evidence (RWE) in regulatory decision-making.
The Application of Real-World Evidence in Regulatory Decision Making
Cerise James, MD, moderates this podcast in which Neil Belson, JD, discusses Real World Evidence and its impact to the biopharmaceutical industry.
Contemporary Applications of Real-World Evidence in Regulatory Decision Making: A Case Series Review
Real-World Evidence can show safety and effectiveness per FDA’s “totality of evidence approach” for evaluating regulatory submissions.
Now More Than Ever, HEOR Plays a Central Role in Forging the Modern Healthcare Agenda
Examine the current state & future of HEOR data in healthcare decision-making; discuss strategies to build strong relationships with payers, the medical community, and patient advocacy groups; determine the impact and value of evidence-based pricing and payment
Best Practices for Managing the Life Cycle of an Investigator-Initiated Research (IIR)
This Webinar will discuss the process of investigator initiated research program followed across industry. The process is initiated externally by submission of IIR application via company website followed by internal company review and decision making process. This results in the execution of IIR study contract between the company and the Institution after which the study is initiated by the Investigator.