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Drug Safety Associate → Basic

Definitions and Terminologies in Pharmacovigilance (GPCPV-DSA002)


Description

INTRODUCTION: 

Understanding the key terms in Pharmacovigilance is critical for accurate communication, case processing, and regulatory compliance. This course provides an in-depth exploration of terminology related to ICSR types, processes, reporting, and special situations, preparing you for real-world scenarios.


Objectives:

  1. To familiarize learners with critical Pharmacovigilance (PV) terms that form the foundation for case processing and reporting.
  2. To explain the significance of ICSR-related terminologies in ensuring compliance and accuracy.
  3. To provide an in-depth understanding of report classifications, enabling learners to handle diverse case types confidently.


Skills You Will Gain

  • ICSR Classification: Ability to identify and classify different types of ICSRs.
  • PV Process Mastery: Comprehensive understanding of terminologies used in ICSR processing.
  • Effective Reporting: Proficiency in terminology for regulatory and compliance reporting.
  • Special Case Analysis: Skill in recognizing and using appropriate terms for special situations in Pharmacovigilance.
Content
  • PV Terminologies Based on Types of Reports of ICSRs
  • Content unit
  • PV Terminologies Based on ICSR Processing
  • Content unit
  • PV Terminologies Based on ICSR Reporting
  • Content unit
  • PV Terminologies Based on Special Situations
  • Content unit
Completion rules
  • All units must be completed
Prerequisites