GoingToMeet

Improving products’ effective clinical safety will increase the industry’s fundamental value proposition to patients, healthcare providers, payors and regulators. The program will focus on pharmacovigilance program implementation and specific strategies and approaches to creating true value from a peri- and post-approval drug safety program. Drug safety programs and monitoring and the approach of this conference are not to look at safety in the silos of early-phase safety or post-approval safety but to view safety holistically, across the lifecycle, especially at the transition from approval to broader use in the marketplace.

The special, three-day executive forum entitled “Post-Approval Drug Safety Strategies: Best Practices to Assess and Mitigate Risks throughout the Product’s Life Cycle” will tackle many of the pressing issues that executives are facing today. Topics include:

* Implementing programs that increase the probability of timely approval and mitigate safety risks
* Aligning resources to design and execute a proactive risk management plan
* Integrating drug safety knowledge longitudinally across a compound's lifecycle
* Optimizing the allocation of an organization's drug safety assessment resources
* Understanding regulatory authorities' evolving drug safety risk management expectations
* Utilizing quantitative approaches for surveillance and signal detection in pharmacovigilance
* Driving your business for the best benefit-risk ratio
* Active surveillance and the Sentinel System