Requirements for medical devices are evolving, making evidence-based decisions more relevant than ever, especially when it comes to proving safety, effectiveness, improved patient outcomes, and regulatory requirements. In addition, there is an increasing need to accomplish this more rapidly and with greater cost-effectiveness. This is where real world data (RWD) and linked data sources come into play. Some of the most pressing challenges include understanding patient profiles, treatment patterns, healthcare burden, and clinical outcomes in the real world environment.
The use of real world evidence (RWE) to support market access decisions, reimbursement strategies, and comparative effectiveness has become increasingly imperative and far-reaching in the last several years. Various data assets, such as medical and prescription claims and electronic medical records (EMR), provide a rich resource in support of clinical evidence development across the medical technology industry.
In this webinar, IQVIA experts will focus on the medical technology (MedTech) environment, examining how and why RWE is imperative and should be leveraged early in planning stages. The speakers will explore ways in which RWE studies can provide meaningful support for research, marketing, clinical, regulatory decision making, and reimbursement requirements.
The presentation will be of most interest for those in the medical device, diagnostic, and equipment space, with roles related to medical affairs, HEOR, regulatory, reimbursement, or RWE.
Share this invitation with a colleague, and we look forwarding to seeing you there!
Key Learning Objectives:
- Understand how RWE strategies can be used to support development needs in the medical technology arena, including research initiatives, market development, and reimbursement planning, using comparative effectiveness analyses.
- Review how rich data sources used in real world evidence studies (e.g., claims data, laboratory data, EMRs, etc.) can be used to support clinical evidence requirements.
- Explore how RWE studies can support regulatory affairs strategies to satisfy market approval requirements.
- Learn how linked/integrated data sources provide options to support evidence development requirements.
- Understand what is needed for success as it relates to the evolving MedTech regulatory landscape and how RWE is being used for regulatory decision-making.