Following a review of the historical perspective of the evolution and necessity of drug safety and Pharmacovigilance in the United States, this course introduces the learner to the regulatory requirements in the clinical trial and post-marketing environments, as well as drug safety monitoring efforts internationally.

Topics include:
      ·          Significant events in the development of drug safety monitoring and adverse event reporting
      ·          Drug safety monitoring efforts exist in the nonclinical trial environment
      ·          Clinical reports
      ·          Post-marketing
      ·          Post-marketing reports
      ·          International safety