Pharmacovigilance Basics – II (Industry Oriented)
Course Objectives:
- Learn the basics of Pharmacovigilance
- Introduction to concepts such as Safety Data Exchange Agreements (SDEA), Pharmacovigilance System Master File (PSMF)
- Veterinary Pharmacovigilance
- Introduction to Hemovigilance
- Introduction to Cosmetovigilance
- Introduction to Materiovigilance
About the Course Facilitator: https://www.linkedin.com/in/drmanojswaminathan/
DONATE: https://www.vigiserve.com/donate
Introduction to Safety Data Exchange Agreements
Sections of PSMF
Main Body and 9 Annexes
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
“Monitoring, reporting, investigation and analysis of adverse events related to the donation, processing and transfusion of blood, and taking action to prevent their occurrence or recurrence.” -WHO
“A set of organized surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors.” - EMA
Introduction and Overview of Veterinary 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/
The terms Labeledness, Expectedness and Listedness are used interchangeably in Pharmacovigilance. Is this correct?
Career Path in the Pharmacovigilance Industry