Pharmacovigilance Basics - I
- Description
- Curriculum
- 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
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Need for a Certification Course in Pharmacovigilance -
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Four Minimum Criteria and Case Validity
One of the most important basic concepts in Pharmacovigilance is four minimum criteria, for Case validity.
- Identifiable reporter
- Identifiable patient,
- Suspect drug, and
- Adverse event information.
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Four Minimum Criteria – Quiz -
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Day Zero in Pharmacovigilance
Day Zero is an important concept in Pharmacovigilance.
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Day Zero – Quiz
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Adverse Event and Adverse Drug Reaction
Important Pharmacovigilance concept: Difference between Adverse Event and Adverse Drug Reaction
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AE Vs ADR – Quiz
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Dechallenge and Rechallenge
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Dechallenge and Rechallenge – Quiz
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Seriousness Criteria for Adverse Events
Seriousness Criteria for Adverse Events
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Seriousness Criteria – Quiz
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Medical Coding in Pharmacovigilance
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/
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Medical Coding in Pharmacovigilance – Quiz
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Event outcome in Pharmacovigilance
Learn about the fate of adverse events
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Event outcome in Pharmacovigilance – Quiz
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Causality Assessment in Pharmacovigilance
Causality Assessment in Pharmacovigilance, for Human Medicinal Products
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IME and DME List in Pharmacovigilance
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
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Case Processing in Pharmacovigilance
Learn about the various steps in Case Processing
What happens to an adverse event after it has been received?
What is a Safety Database?
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Case Processing in Pharmacovigilance - Quiz
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Qualified Person for Pharmacovigilance
Roles and responsibilities of the QPPV
Country specific requirements
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QPPV - Quiz
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Pharmacovigilance Audit Vs Inspection
The difference between an audit and an inspection
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Pharmacovigilance Audit Vs Inspection - Quiz
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WHO Pharmacovigilance Resources
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
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Designing a good CV or Resume for getting a dream job in Pharmacovigilance
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
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Preparing for a Pharmacovigilance Job Interview
