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Drug Safety and Pharmacovigilance Across the Product Lifecycle
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
Global Safety Regulatory Resources 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
- 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