Pharmacovigilance Basics – I
- 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/
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.
Day Zero is an important concept in Pharmacovigilance.
Important Pharmacovigilance concept: Difference between Adverse Event and Adverse Drug Reaction
Seriousness Criteria for Adverse Events
Medical Coding - MedDRA, VeDDRA, WHO DD, Snomed CT, CTCAE
SNOMED CT: https://browser.ihtsdotools.org/
Learn about the fate of adverse events
Causality Assessment in Pharmacovigilance, for Human Medicinal Products
The Important Medical Event (IME) and the Designated Medical Event (DME) in Pharmacovigilance.
EMA Webpage for accessing the IME List:
Send Queries on the IME List:
Inclusion / Exclusion Criteria: https://www.ema.europa.eu/en/documents/other/inclusion-exclusion-criteria-important-medical-events-list-meddra_en.pdf
DME List: https://www.ema.europa.eu/en/documents/other/designated-medical-event-dme-list_en.xlsx
Learn about the various steps in Case Processing
What happens to an adverse event after it has been received?
What is a Safety Database?
Roles and responsibilities of the QPPV
Country specific requirements
The difference between an audit and an inspection
Free and useful Pharmacovigilance resources that are provided and facilitated by the World Health Organization.
Having a good resume or CV is very important for getting the dream job in Pharmacovigilance.
Is it CV or resume?
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