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
2.5 Minutes

Introduction to Safety Data Exchange Agreements

https://www.vigiserve.org/donate

2
Introduction to SDEA
2 questions
3
PSMF Sections
13 Minutes

Sections of PSMF

Main Body and 9 Annexes

4
PSMF – Sections
6 questions
5
What is REMS?
6
Periodic Adverse Experience Reports (PADERs) in the United States
7
US PADERs
6 questions
8
CosmetoVigilance – An Introduction
6.5 minutes
9
Introduction to Hemovigilance
7 Minutes

“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
4 questions
11
Introduction and Overview of Veterinary Pharmacovigilance
7 Minutes

Introduction and Overview of Veterinary Pharmacovigilance

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Enrolled: 69 students
Duration: 120 Minutes
Lectures: 7

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