Demo class of "Pharmacovigilance Practical ICSR Course"24:42
Develop practical pharmacovigilance skills by applying the CSR process to real case scenarios, including case validity, MedDRA event coding, seriousness, labeling, causality, and narrative writing.

ICSR Introduction and Case Validity updated30:27
Duplicate search and MedDRA46:36
Master duplicate search to prevent misleading signals and ensure accurate pharmacovigilance data. Learn practical MedDRA event coding and duplicate handling before and after case creation.
MedDRA in Argus and ICH M1 reference10:10
Learn to select and code events in MedDRA using Argus and ICH M1 reference, including event tab coding, linking symptoms, and applying MedDRA term selection guidelines.
Seriousness assessment19:51
Learn to perform seriousness assessment in pharmacovigilance using e2e guidelines, MedDRA coding, and medical judgment to classify events as death, life-threatening, hospitalization, disability, congenital anomalies, or medically important events.
Labelling assessment19:27
Master the labeling assessment in pharmacovigilance by evaluating adverse events against RSI documents. Refer to investigator brochure or core data sheet to classify events as labeled or unlabeled.
Causality assessment26:21
Learn how causality assessment determines if an adverse event is related to a drug, guiding signal management and risk evaluation using factors like temporal association, rechallenge, labeling, and Narendra scale.
Narrative writing, case processing in ARGUS, Case prioritization34:11
Learn narrative writing and case processing in ARGUS, including case validity, duplicate search, event coding, seriousness and causality, and case prioritization for regulatory submissions.

Requirements

Basic level of English and good quality of internet connection, Desktop /Laptop/Smartphone required(Since dealing with online mode)
Basic Knowledge on medical field

Description

This course is continuation to our Basic ICSR course, In this course we will mainly focused on Practical case scenarios.

Practical ICSR : A development Course to set you up for success at work.

Trainer Ramya Mam has 10+ years of Experience in Pharmacovigilance. She was expertise in ICSR Processing, Literature search, Signal assessment and aggregate writing.

What we will talk about in this course is

- Introduction to ICSR

- Our Training Objective

- Training benefits

- Topics covered in this course

- Summary of key learnings

- Checking for understanding

Our Training objective:

- This is development course to include practical case scenarios of ICSR and guide to apply theoretical concepts into practice.

Training benefits:

- Apply theoretical ICSR concepts into practical case scenario.

- A development course to set you up for success at work.

- Practical case scenarios with live MedDRA access.

- Logical thinking and critical evaluation of cases.

- case prioritization.

Topics covered in this course

a) Introduction to ICSR

- Case Validity

- Duplicate search

- Event selection and coding with MedDRA

- seriousness assessment

- Labelling assessment

- Causality assessment

- Narrative writing

b) Practical case scenarios

- Examples of case validity

- MedDRA practical

- Case scenarios for seriousness assessment

- Case scenarios for Labelling assessment

- Case scenarios for causality assessment

- Sample narrative writing

c) Case prioritization rules

- Regulatory authority submission timelines

Who this course is for:

Graduate or postgraduate degree in Pharmacy or Pharmaceutical Sciences
Graduate or postgraduate degree in Medicine
Graduate or postgraduate degree in Chemistry (subject) .
Pharmacovigilance early experience candidates

Certificate Course in "Pharmacovigilance Practical ICSR"

What you'll learn

Explore related topics

Course content

Demo class1 lecture • 25min

Complete Course7 lectures • 3hr 7min

Requirements

Description

Who this course is for: