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.

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

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