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RTI Health Solutions to Attend IQPC Pharmacovigilance North America Conference, September 26-28, 2011
posted 2011.7.26

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.

 

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