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Clinical Safety & Pharmacovigilance

Global Pharmacovigilance Strategies from the Experts Who Know Them

Our expert faculty address the practical and theoretical aspects of pharmacovigilance, with emphasis on the concepts, effective processes, and safety principles of global regulatory compliance

This Certificate Program will provide the fundamental skills you need to do your job. Topics include, but are not limited to:

  • Premarketing clinical safety and pharmacovigilance
  • Postmarketing drug safety and pharmacovigilance
  • Risk management strategies
  • How to prepare for a safety inspection
  • Signal detection and data mining

Certificate Program Requirements

To successfully complete this Certificate Program, learners must complete 16 core units and 16 elective units; courses included in this program are noted below:

Course Title
Format
CSP Certificate
Program Units

Adverse Event Reporting Requirements: IND and Postmarketing
Online
3 Elective Units
How to Prepare for a Safety Inspection
Online
3 Elective Units
Introduction to Signal Detection and Data Mining
Online and Face-to-face
4 Elective Units
Postmarketing Drug Safety and Pharmacovigilance
Face-to-face
8 Core Units
Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
Face-to-face
16 Core Units
Premarketing Clinical Safety and Pharmacovigilance
Face-to-face
8 Core Units
Risk Management and Safety Communication Strategies
Face-to-face
8 Elective Units
* additional meetings and webinars are available to meet the elective unit requirements and will be noted in the upcoming schedule list below

* Completion of the Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum training course will meet the core requirements in lieu of taking both the Premarketing Clinical Safety and Pharmacovigilance and Postmarketing Drug Safety and Pharmacovigilance training courses.

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Certificate Program Requirements

Core (Must successfully complete 16 Clinical Safety & Pharmacovigilance Certificate Program (CSPCP) Core Units)
Electives (Must successfully complete 16 Clinical Safety & Pharmacovigilance Certificate Program (CSPCP) Elective Units)