Free Seminar

Phase Forward's Lincoln Safety Group is pleased to invite you to a free seminar regarding the increasing complexity and challenges of the evolving drug-safety landscape. In today’s hyper-vigilant environment, successful pharmaceutical, medical device and biotech companies must capitalize on the full potential of the wide variety of tools and capabilities available to help them proactively assess risk and manage safety issues throughout the entire product lifecycle.

Participants will gain insight into the expanding dynamics of the drug-safety environment and learn about current trends and available tools that will assist in the development and implementation of a global risk-management strategy — from clinical development through post-marketing.

Topics will include:

  • Review and discussion of current government and industry drug safety initiatives
  • Practical considerations in signal detection and data mining
  • The challenges and benefits of working with multiple data sources: clinical trials, spontaneous reports, and longitudinal health data
  • Best practice approaches to pharmacovigilance and safety signal management


Agenda and Presenters

8:30 a.m. Complimentary breakfast buffet
9:00 Welcome and Opening Remarks
9:15 The Evolving Drug Safety Landscape: Should You Be Doing More?
Wayne Kubick, Vice President, Phase Forward Lincoln Safety Group
10:00 Questions and Answers
10:15 Break
10:30 Practical Considerations in Data Mining and Signal Detection Using Clinical Trials, Post-Marketing and Longitudinal Safety Data
William DuMouchel, Chief Statistical Scientist, Phase Forward Lincoln Safety Group
11:15 Examples of Best Practices in Technology-driven Pre- and Post-Marketing Safety Monitoring and Management
11:45 Conclusions: The Evolving Drug Safety Landscape: Are You Ready?
Wayne Kubick and William DuMouchel
12:00 p.m. Complimentary lunch and demos of the Phase Forward Empirica™ Suite

Presenters

Wayne Kubick, Vice President, Phase Forward Lincoln Safety Group
William DuMouchel, Chief Statistical Scientist, Phase Forward Lincoln Safety Group


Locations

This free seminar will be held in four locations:

Please direct any questions to Amy Dall by email at amy.dall@phaseforward.com or by phone at (781) 902-4683.