RESEARCH TRIANGLE PARK, NC - Maria Alejandra Vazquez-Gragg, MD, MPM, ISPOP, Senior Director, Global Head of Safety and Pharmacovigilance, will be speaking at the Pharmacovigilance North America Conference, September 26-28, 2011 in Philadelphia, PA.
Dr. Vazquez-Gragg will moderate the keynote session titled, "Greatest Challenges to PV Compliance in 2010 & 2011" on Tuesday, September 27 at 9:00am. The panel will discuss:
- Economic pressure of PV EU pharmaceutical regulations
- Analyzing the reason and solutions for increased inspections and audits
- Litigation and risk
- Latest developments and trends within PV technology
On Wednesday, at 11:15am she will discuss, "The Evolution of REMS: Unintended Consequences on Spontaneous Reporting". This session will focus on:
- Impact of spontaneous reporting during REMS programs
- Advantage of strategies to increase the speed and predictive value of generating and evaluating safety signals during a REMS program
- How each of these approaches can be leveraged to address overall safety and regulatory concerns
- Unifying the European RMP with the FDA REMS
As chairperson, Dr. Vazquez-Gragg outlines important conference topics in this featured podcast.
Please contact Maria directly if you plan to attend the conference and would like to pre-arrange a time to meet with her.