Certificate Course in "Pharmacovigilance Practical ICSR"

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

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