Managing the Risks of Implementing E6R2
Successful implementation of RBQM is a challenge many in our industry are facing. To understand what it is and how it impacts the management of your clinical trial, this webinar will address what exactly E6R2 is. We will use Rho as a case study for designing and implementing a strategy, discuss common misconceptions, and review lessons Rho has learned through implementation of RBQM.
Marina Acosta Enslen
Director, Clinical Management
Marina Acosta Enslen has been involved in the conduct of clinical trials for 20 years, working in academia, pharmaceutical, and CRO markets. She has experience working on NIH and industry funded Phase 1 – 4 global clinical trials. Much of her career has been focused in infectious disease, primarily HIV/AIDS and HPV research providing clinical trial coordination, monitoring and clinical team leadership. Ms. Acosta Enslen’s broad experience from multiple perspectives and strong understanding of clinical trial management particular to infectious disease trials has allowed her to successfully lead teams. Prior to joining Rho, Ms. Acosta Enslen’s experience included the conduct…
Senior Project Manager
Missy Lavinder has over 18 years of clinical trial experience, providing clinical operations oversight and project management within the clinical trial arena. Beginning her career with a focus in Neurosciences research, she has spent the past 6 years conducting pain, dermatology, genetic, and rare disease trials. On both U.S. and global programs, Ms. Lavinder has provided oversight and full management support for multiple pain and dermatology studies and multiple rare disease studies. Recently, Ms. Lavinder served as the Project Manager for a highly complex trial in Hereditary Angioedema, a rare genetic condition, which ultimately led to FDA approval of the…