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

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2
Introduction to SDEA – Quiz
6 questions
3
PSMF Sections
13 Minutes

Sections of PSMF

Main Body and 9 Annexes

4
PSMF – Intro – Quiz
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 – Quiz
4 questions
12
Introduction and Overview of Veterinary Pharmacovigilance
7 Minutes

Introduction and Overview of Veterinary Pharmacovigilance

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13
Medical Coding in Pharmacovigilance
33 Minutes

Medical Coding - MedDRA, VeDDRA, WHO DD, Snomed CT, CTCAE

Relevant Links:

CTCAE: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm

SNOMED CT: https://browser.ihtsdotools.org/

VeDDRA: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/combined-veterinary-dictionary-drug-regulatory-activities-veddra-list-clinical-terms-reporting_en.pdf

MedDRA: https://www.meddra.org/

14
Medical Coding in Pharmacovigilance – Quiz
7 questions
15
Labeledness Vs Listedness Vs Expectedness in Pharmacovigilance
11 Minutes

The terms Labeledness, Expectedness and Listedness are used interchangeably in Pharmacovigilance. Is this correct?

16
Expectedness, Labeledness and Listedness – Quiz
4 questions
17
Career Path in the Pharmacovigilance Industry
12 Minutes

Career Path in the Pharmacovigilance Industry

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18
Career in Pharmacovigilance – Quiz
4 questions

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Enrolled: 1368 students
Duration: 120 Minutes
Lectures: 11

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