As traditional renal and hepatic impairment studies have shifted, efficiently conducting these studies to understand the effect of a treatment and achieve regulatory approval requires a comprehensive, cross-functional strategy.
TORONTO (PRWEB) June 09, 2020
From study design to feasibility assessment to patient enrollment, many important considerations factor into achieving timely completion of renal/hepatic impairment studies. As traditional renal and hepatic impairment studies have shifted, efficiently conducting these studies to understand the effect of a treatment and achieve regulatory approval requires a comprehensive, cross-functional strategy.
Join this webinar to hear from four specialists in the field as they share their insights for optimizing a clinical development plan, identifying key protocol parameters, best practices for managing the medical and scientific aspects of impairment studies and how to choose the right sites and perform start-up quickly. They will also cover practical considerations for handling the complexity of Phase I studies, conducting a “reduced PK study” per the FDA guidance and working with dialysis cohorts.
Join Jane Royalty, MD, Senior Medical Director, Clinical Pharmacology Services, Covance, Thomas C. Marbury, MD, President, Orlando Clinical Research Center, Jackie Miller-Giles, MS, Senior Clinical Scientist, Clinical Pharmacology Services, Covance and Jasmine Ropers, Senior Project Manager, Covance Clinical Pharmacology Services in a live webinar on Friday, June 19, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit Renal and Hepatic Impairment Studies: Optimizing Strategies in Clinical Developmen t.
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.