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Pharmacovigilance Basics
Course Objectives: Learn the basics of Pharmacovigilance Introduction to concepts such as Safety Data Exchange Agreements (SDEA), Pharmacovigilance...
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The Federal Food, Drug & Cosmetic Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced ...
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Hemovigilance refers to the Monitoring, reporting, investigation and analysis of adverse events related to the donation, processing and transfusion...
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Materiovigilance or Device Vigilance
Medical Devices’ Safety
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Benefit and Risk Management
Advanced Pharmacovigilance
A Pharmacovigilance System Master File (PSMF) is a document describing the pharmacovigilance system maintained by the marketing authorisation holde...
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Pharmacovigilance Basics
Course Objectives: Learn the basics of Pharmacovigilance Introduction to concepts such as Day Zero, Four Minimum Criteria, Seriousness, Causality, ...
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Free
Safety Data Exchange Agreements (SDEA) are legal contracts meant for ensuring prompt exchange of safety data with the business partner, that will e...
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Case Processing Lifecycle
Course Objectives: Basic concepts required for case-processing Concept of Day Zero, Four Minimum Criteria, Seriousness, Dechallenge-Rechalle...
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Career and Opportunities
Course Objectives: Industry Overview Why should you choose this field? Various career options in Pharmacovigilance Domain Preferred Qualifications ...
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Advanced Pharmacovigilance
A signal is essentially a hypothesis of a risk with a medicine with data and arguments that support it, derived from data from one or more of many ...
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Country Specific Requirements
Learn about the Pharmacovigilance requirements in various countries.
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