Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Seaport Hotel

Aug 15, 2019 2:00 PM - Aug 16, 2019 10:45 PM

One Seaport Lane, Boston, MA 02210

The Pharmacovigilance Quality Management System

Learn how to design, develop, and manage a quality system related to your pharmacovigilance system.

Session 8: Pharmacovigilance in the Study and Clinical Trial Environment

Session Chair(s)

Yvonne  Ditoro, BSN, MBA, RN

Yvonne Ditoro, BSN, MBA, RN

Pharmacovigilance Operations Consultant

Yvonne Ditoro and Associates LLC, United States

  • Review of study classification, causality assessments, expedited reporting, reference safety information, and other areas subject to pharmacovigilance audits and inspections
  • Pharmacovigilance-related clinical processes and cross-functional SOPs
  • Safety Management Plans, when they are required, and key elements to include

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.