Certificate Course in "Pharmacovigilance Practical ICSR"
Practical ICSR, Case Validity, MedDRA in ARGUS, Seriousness assessment, Causality assessment, Case processing in ARGUS.
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
What You Will Learn!
- ICSR Introduction and Case Validity
- Duplicate search
- Event selection and coding with MedDRA
- MedDRA in Argus and ICH M1 reference
- Seriousness assessment
- Labelling assessment
- Causality assessment
- Narrative writing, case processing in ARGUS, Case prioritization
Who Should Attend!
- 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