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
IME and DME List in Pharmacovigilance
9 Minutes

The Important Medical Event (IME) and the Designated Medical Event (DME) in Pharmacovigilance.


Useful links:

EMA Webpage for accessing the IME List:

https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-system-overview


Send Queries on the IME List:

https://www.ema.europa.eu/en/about-us/contact/send-question-european-medicines-agency


Inclusion / Exclusion Criteria: https://www.ema.europa.eu/en/documents/other/inclusion-exclusion-criteria-important-medical-events-list-meddra_en.pdf


IME List:

https://www.ema.europa.eu/documents/other/meddra-important-medical-event-terms-list-version-250_en.xlsx


DME List: https://www.ema.europa.eu/en/documents/other/designated-medical-event-dme-list_en.xlsx

6
What is REMS?
7
Periodic Adverse Experience Reports (PADERs) in the United States
8
US PADERs
6 questions
9
CosmetoVigilance – An Introduction
6.5 minutes
10
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

11
Hemovigilance
4 questions
12
Introduction and Overview of Veterinary Pharmacovigilance
7 Minutes

Introduction and Overview of Veterinary Pharmacovigilance

https://www.vigiserve.org/donate

13
Career Path in the Pharmacovigilance Industry
12 Minutes

Career Path in the Pharmacovigilance Industry

https://www.vigiserve.com/donate

14
Career in Pharmacovigilance
2 questions

Be the first to add a review.

Please, login to leave a review
Add to Wishlist
Enrolled: 1124 students
Duration: 120 Minutes
Lectures: 9

Archive

error: Content is protected !!