Connect with Us
602 Park Point Drive, Suite 225, Golden, CO 80401 – +1 303.495.2073
© 2024 Medical Affairs Professional Society (MAPS). All Rights Reserved Worldwide.
Join Dr Omar Dabbous, Vice President, Health Economics and Outcomes Research (HEOR) and Real World Evidence (RWE) at AveXis, and Russell Becker, MA, HEOR Consultant, demonstrate HEOR’s front-and-center role in forging the modern healthcare agenda.
As healthcare systems worldwide become increasingly budget-constrained and cost conscious, stakeholders are placing greater emphasis on health economics demonstration and product potential in real-world practice. Once viewed solely as a support function, HEOR now often takes center stage in the internal decision-making process. As life sciences companies bring HEOR professionals and brand strategists together to formulate streamlined value chains, the function now provides essential data for licensing and R&D, as well as pricing and market access strategies, helps dictate research, planning and sales strategies.
This MAPS eCademy Webinar will:
Investigator Initiated Research is defined as ‘unsolicited‘, independent research where the Investigator or the Institution (academic, private or governmental) serves as the ‘Sponsor’ and a pharmaceutical or medical device company provides support in the form of drug/device and/or funding. A well-designed investigator initiated study can gain insights related to disease state and/or the clinical or scientific profile of a companies products. This may ultimately lead to improved evidence-based medicine and outcomes for patients.
We 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.
Making the best possible choices about health care requires the best possible evidence upon which to base these important decisions. High quality evidence comes from many sources including real world data (RWD). The sources of RWD are numerous including electronic health records, claims and billing data, product and disease registries and patient-reported data.
Analysis of RWD leads to clinical evidence known as real world evidence (RWE) regarding the usage and risks and benefits of a therapy. Under the right conditions, RWD and the RWE that follows may be used to support regulatory decisions and contribute to the knowledge of a drug or therapy. RWE may help to support improved decision-making about health and health care.
After completing this Webinar, participants will be able to:
•List the sources of real world data (RWD),
•Understand how real world evidence (RWE) can help to support a regulatory decision,
•Recognize when in the product life cycle RWD/RWE may be useful,
•Utilize a patient-centric framework to develop a RWD/RWE generation plan.
Join Dr. Leon Rozen, Senior Medical Director, Global Oncology at AbbVie, and Dr. Kirk Shepard, Senior Vice President, Head of Global Medical Affairs Oncology at Eisai as they explore how to build agility into your Medical Affairs strategy.
Medical Affairs organizations have a central and strategic role in creating and communicating strategy, and it is critical to build agility into the strategy. Building agility into Medical Affairs strategic planning can be achieved incrementally as you execute. To be more effective we need to host regular review meetings that alternately review strategy and execution and involve the people who are responsible for insights.
After this Webinar, you will be able to:
602 Park Point Drive, Suite 225, Golden, CO 80401 – +1 303.495.2073
© 2024 Medical Affairs Professional Society (MAPS). All Rights Reserved Worldwide.