Submitted by Damir Simic and Mausumee Guha, Chairpersons of the PM12 Continuing Education (CE) Course
When target/compound safety issues arise during drug development, are you ready to respond effectively and rapidly? What are the critical questions that need to be answered? What are the tools and strategies an investigative toxicologist can use to answer these questions in a time critical but comprehensive manner for teams to understand and mitigate preclinical and clinical risk?
Dealing with impending safety concerns is further complicated by the scientific capability, communication team, and organizational priorities as well as the regulatory environment. Through real life examples, this CE course will outline investigative toxicology strategies used in pharmaceutical development from early discovery to life-cycle management. It will focus on three key areas: designing testable hypotheses; data communication; and decision-making that impact project outcomes.
The five Best Practices lectures will highlight strategies unique to each of the development steps. The attendees will learn about the regulatory perspective of value-added investigative efforts, as well as the implementation of novel tools such as MindMaps, and the prioritization matrix as part of the target safety profile assessment.
We invite you to register for the PM12 CE course today! Access a full listing of the CE courses at the 2015 SOT Annual Meeting website.