This presentation, part 3 of 3, provides insights into the types of communications that the FDA has indicated are or are not permissible, and the uncertainties that still remain.
In this episode, we hear from RWE and industry experts on the importance of early alignment of your evidence generation plan and medical strategy and how to integrate RWE into your publication plan.
In today’s episode, we speak with Chris Medieros about how to maximize your organization’s presence and impact at congresses.
This Webinar series explores the fundamental concept of big data in Medical Affairs, from which sources can we retrieve this, what are the broader considerations when utilizing data in health and what impact this can have on our organizations, physicians, and patients, now and in the future.
This presentation looks at different regulatory contexts in which product developers are using RWE.
MAPS speaks with Stefan C. Weiss, MD, Managing Director, Dermatology at OM1 about EMR patient data overlain with technology to create a more accurate and equitable view of post-market safety.
This virtual presentation focuses on 3 aspects of RWE: What are RWE and Real-World Data (RWD), and how are they different? What are relevant legal and regulatory considerations associated with using RWE for product label expansion? How have applicants successfully used RWE to obtain approval for new drug and medical device indications?
This white paper provides Medical Affairs professionals with the background and history of Real-World Evidence, and its applications in the biopharma industry to benefit patients.
This podcast focuses on applications of Real World Evidence including FDA criteria for accepting RWE, types of data, RWE study designs and the Totality of Evidence approach.
There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for applications including regulatory decisions, health technology assessment (HTA), pharmacovigilance and more. However, Asia currently lacks a framework to effectively collect and utilize a broad range of RWD/RWE.