Drug Safety and Pharmacovigilance Across the Product Lifecycle

Session Chair(s)

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