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  1. 3. Don't forget these BLANK BLANK products (fill in the blanks)!
  2. 5. Enhanced monitoring of safety events of special interest in the post-marketing setting includes this serious, life-threatening CNS infection.
  3. 6. This is Jackie's (and TG's) motto for the act of collaboration :)
  4. 7. Role responsible for establishing and maintaining the pharmacovigilance system, having an overview of the safety profile and emerging safety concerns, and acting as a single contact point for health authorities on a 24-hour basis in the EU.
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  1. 1. This document describes the company's internal position on risks associated with a drug product, including its pharmacovigilance activities and minimization measures.
  2. 2. Post-marketing periodic drug safety reports required to be submitted quarterly for the first 3 years after drug approval in the US per FDA regulations.
  3. 4. This document is a regional document discussing important risks and how to manage them.
  4. 5. The acronym for a detailed description of the pharmacovigilance system to be set in place by first marketing authorization in the EU.
  5. 8. These are studies conducted post-approval to further characterize safety-related concerns.