Pharmacovigilance Basics – I
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
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
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/
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.
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
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.
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
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