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Pre-Course Work – can be done at any time prior to the live event
Session Chair(s)
Mark Vieder, MBA, RPh
Vice President, Drug Safety and Pharmacovigilance
Biorasi, LLC, 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
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