Pharmacovigilance Basics – II (Industry Oriented)
Course Objectives:
- Learn the basics of Pharmacovigilance
- Introduction to concepts such as Safety Data Exchange Agreements (SDEA), Pharmacovigilance System Master File (PSMF)
- Veterinary Pharmacovigilance
- Introduction to Hemovigilance
- Introduction to Cosmetovigilance
- Introduction to Materiovigilance
About the Course Facilitator: https://www.linkedin.com/in/drmanojswaminathan/
DONATE: https://www.vigiserve.com/donate
1
Introduction to Safety Data Exchange Agreements
Introduction to Safety Data Exchange Agreements
2
Introduction to SDEA
3
PSMF Sections
Sections of PSMF
Main Body and 9 Annexes
4
PSMF – Sections
5
What is REMS?
6
Periodic Adverse Experience Reports (PADERs) in the United States
7
US PADERs
8
CosmetoVigilance – An Introduction
9
Introduction to Hemovigilance
“Monitoring, reporting, investigation and analysis of adverse events related to the donation, processing and transfusion of blood, and taking action to prevent their occurrence or recurrence.” -WHO
“A set of organized surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors.” - EMA
10
Hemovigilance
11
Introduction and Overview of Veterinary Pharmacovigilance
Introduction and Overview of Veterinary Pharmacovigilance
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