Medical Review – Basics

VigiServe Foundation is a registered Non-Profit in India (CIN U85300MH2020NPL339935) with a mission of Empowering Public Health by ensuring safe medicines and promoting a culture for reporting Adverse Drug Experiences and Side Effects.

To DONATE, click here

1
Four Minimum Criteria for Case-Report Validity
20 Minutes

Four Minimum Criteria:

Identifiable Patient

Identifiable Reporter

Suspected Drug

Adverse Event

2
Day Zero
13 Minutes
3
Day Zero – Quiz
3 questions
4
Adverse Event Vs Adverse Drug Reactions
15 Minutes

Learn about the difference between an Adverse Event and an Adverse Drug Reaction

5
AE Vs ADR – Quiz
2 questions
6
Seriousness Assessment in Pharmacovigilance
16 Minutes

Adverse Events can be Serious!

Important Medical Event List: https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-system-overview

7
Seriousness Criteria – Quiz
2 questions
8
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

9
Causality Assessment in Pharmacovigilance
23 Minutes

Relatedness assessment - To evaluate the relationship between the suspect drug and the adverse event.

Link to WHO-AEFI Causality Assessment: https://www.who.int/publications/i/item/9789241516990

Link to WHO-UMC Causality:https://www.who.int/publications/m/item/WHO-causality-assessment

10
Causality Assessment – Quiz
6 questions
11
Case-Narratives in Pharmacovigilance
20 Minutes
12
Narrative Writing – Quiz
5 questions
13
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/

14
Medical Coding in Pharmacovigilance – Quiz
7 questions
15
Medical Review in Pharmacovigilance
13 Minutes

The role of medical reviewers and safety physicians in Pharmacovigilance

16
Medical Review in Pharmacovigilance – Quiz
5 questions

Be the first to add a review.

Please, login to leave a review
Enrolled: 28 students
Duration: 5 Hours
Lectures: 9
Video: 5 Hours
Level: Beginner

Archive

error: Content is protected !!