Pharmacovigilance Basics – I

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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 – Quiz
4 questions
4
Day Zero in Pharmacovigilance
3 Minutes

Day Zero is an important concept in Pharmacovigilance.

https://www.vigiserve.org/donate

5
Day Zero – Quiz
3 questions
6
Adverse Event and Adverse Drug Reaction
3 Minutes

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

7
AE Vs ADR – Quiz
2 questions
8
Dechallenge and Rechallenge
13 Minutes
9
Dechallenge and Rechallenge – Quiz
3 questions
10
Seriousness Criteria for Adverse Events
4 Minutes

Seriousness Criteria for Adverse Events

11
Seriousness Criteria – Quiz
2 questions
12
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/

13
Medical Coding in Pharmacovigilance – Quiz
7 questions
14
Event outcome in Pharmacovigilance
3 Minutes

Learn about the fate of adverse events

15
Event outcome in Pharmacovigilance – Quiz
5 questions
16
Causality Assessment in Pharmacovigilance
4 Minutes

Causality Assessment in Pharmacovigilance, for Human Medicinal Products

17
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

18
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?

19
Case Processing in Pharmacovigilance – Quiz
8 questions
20
Qualified Person for Pharmacovigilance
30 Minutes

Roles and responsibilities of the QPPV

Country specific requirements

21
QPPV – Quiz
6 questions
22
Pharmacovigilance Audit Vs Inspection
11 Minutes

The difference between an audit and an inspection

23
Pharmacovigilance Audit Vs Inspection – Quiz
5 questions
24
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

25
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

26
Preparing for a Pharmacovigilance Job Interview
20 Minutes
5
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Enrolled: 558 students
Lectures: 16

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