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Drug Safety and Pharmacovigilance Across the Product Lifecycle

Build a solid foundation in the key concepts of drug safety and pharmacovigilance throughout the medical product development lifecycle. Learn how to comply with regulatory requirements.

Pre-Course Work – can be done at any time prior to the live event

Session Chair(s)

Jill W. Buckley, PharmD

Jill W. Buckley, PharmD

  • Adjunct Assistant Professor
  • Rutgers, the State University of New Jersey, United States
Precourse work can be done at any time prior to the live event.
  • Module 1: Introduction to Drug Safety eLearning module
    • Lesson 1: The Basics
      • Definition of PV
      • History of PV
      • Overview of Drug Development and Clinical Trial Phases
      • Essential Pre-Marketing PV Activities
      • PV in Post-Marketing
    • Lesson 2: Terminology
      • Basic Terminology
      • Adverse Event Terminology
      • Medical Terminology
  • Module 2: Drug Safety Regulatory Requirements eLearning module
    • Lesson 1: Harmonization Initiatives
      • ICH
      • HL7
      • CDISC
      • CIOMS
      • ICH Safety Guidelines
      • CIOMS Documents
    • Lesson 2: Important US Regulations
      • US FDA Organization
      • FDA Resources for Industry
      • Legal Hierarchy in the US
      • Key US Laws and Guidances
    • Lesson 3: Important EU Regulations
      • EU Geography
      • EMA
      • Legal Hierarchy in the EU
      • Key EU Drug Safety Documents
    • Lesson 4: 2010 EU Legislation
      • Good Pharmacovigilance Practices
      • Product Authorization and Maintenance
      • Adverse Drug Reactions
      • PSUR Changes
      • Post-Authorization Studies
      • Pharmacovigilance Master File
      • European Medicines Web Portal
      • Pharmacovigilance Inspections
      • Risk Management System
      • European Commission Reports
      • Pharmacovigilance Fees
Global Safety Regulatory Resources eLearning module

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