Pharmacovigilance Basics – I

5 out of 5
5
3 reviews

Course Objectives:

  • Learn the basics of Pharmacovigilance
  • Introduction to concepts such as Day Zero, Four Minimum Criteria, Seriousness, Causality, and Dechallenge-Rechallenge
  • Adverse Event Vs Adverse Drug Reaction
  • Sources of Adverse Events

About the Course Facilitator: https://www.linkedin.com/in/drmanojswaminathan/

DONATE: https://www.vigiserve.com/donate

1
Need for a Certification Course in Pharmacovigilance
3.5 Minutes
2
Four Minimum Criteria and Case Validity
3 Minutes

One of the most important basic concepts in Pharmacovigilance is four minimum criteria, for Case validity.

  1. Identifiable reporter
  2. Identifiable patient,
  3. Suspect drug, and
  4. Adverse event information.

https://www.vigiserve.org/donate

3
Four Minimum Criteria
3 questions

1
Day Zero in Pharmacovigilance
3 Minutes

Day Zero is an important concept in Pharmacovigilance.

https://www.vigiserve.org/donate

2
Day Zero
2 questions

1
Adverse Event and Adverse Drug Reaction
3 Minutes

Important Pharmacovigilance concept: Difference between Adverse Event and Adverse Drug Reaction

2
AE Vs ADR
2 questions

1
Sources of Adverse Event Reports
6 minutes

Learn about the various sources of adverse event reports.

2
Sources of Adverse Events
5 questions
3
Seriousness Criteria for Adverse Events
4 Minutes

Seriousness Criteria for Adverse Events

4
Seriousness Criteria
2 questions

1
Causality Assessment in Pharmacovigilance
4 Minutes

Causality Assessment in Pharmacovigilance, for Human Medicinal Products

2
Event outcome in Pharmacovigilance
3 Minutes

Learn about the fate of adverse events

3
Event outcome in Pharmacovigilance
3 questions
4
Dechallenge and Rechallenge
13 Minutes
5
Dechallenge and Rechallenge
3 questions
6
Case Processing in Pharmacovigilance
30 Minutes

Learn about the various steps in Case Processing

What happens to an adverse event after it has been received?

What is a Safety Database?

7
Case Processing in Pharmacovigilance
8 questions
8
WHO Pharmacovigilance Resources
13 Minutes

Free and useful Pharmacovigilance resources that are provided and facilitated by the World Health Organization.


Useful links:

https://whopvresources.org/

https://learning.who-umc.org/

https://who.csod.com/client/who/default.aspx

https://www.who-umc.org/media/1061/abbreviations.pdf

https://www.who.int/publications/i

9
Qualified Person for Pharmacovigilance
30 Minutes

Roles and responsibilities of the QPPV

Country specific requirements

10
QPPV
6 questions
11
Pharmacovigilance Audit Vs Inspection
11 Minutes

The difference between an audit and an inspection

12
Pharmacovigilance Audit Vs Inspection
5 questions
13
Designing a good CV or Resume for getting a dream job in Pharmacovigilance
27 min

Having a good resume or CV is very important for getting the dream job in Pharmacovigilance.

Is it CV or resume?

How many pages?

Should I include my Foto or signature?

Tool: www.canva.com

Other links:

https://youtu.be/d7D1p5Y5X8g

14
Preparing for a Pharmacovigilance Job Interview
5
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Enrolled: 1936 students
Duration: 3 Hours
Lectures: 15
Level: Beginner

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