Certificate Course in "Pharmacovigilance Practical ICSR"

Practical ICSR: A Development Course for Pharmacovigilance Success

Building upon your foundational knowledge from our Basic ICSR course, this practical training dives deep into real-world applications of ICSR (Indication of Suspected Adverse Drug Reaction) processing. Get ready to enhance your skills and prepare for success in a pharmacovigilance role.

Led by Ramya Mam, a seasoned pharmacovigilance expert with 10+ years of experience, this course offers hands-on insights into ICSR processing, literature searches, signal assessment, and aggregate report writing.

What You'll Learn:

• Course Objectives: This development course focuses on practical ICSR case scenarios, guiding you to effectively apply theoretical concepts in a real-world setting.
• Training Benefits:
  • Apply ICSR Concepts: Translate theoretical knowledge into practical application through realistic case studies.
  • Career Advancement: A development course designed to set you up for success in your pharmacovigilance career.
  • Live MedDRA Access: Work with practical case scenarios utilizing live MedDRA (Medical Dictionary for Regulatory Activities) access.
  • Critical Thinking: Develop logical thinking and critical evaluation skills for complex cases.
  • Case Prioritization: Learn effective strategies for prioritizing ICSR cases.
• Topics Covered:
  • Introduction to ICSR:
    • Case Validity: Learn to assess the validity of ICSR reports.
    • Duplicate Search: Master techniques for identifying and handling duplicate reports.
    • Event Selection & Coding (MedDRA): Develop proficiency in selecting and coding events using the MedDRA terminology.
    • Seriousness Assessment: Understand and apply criteria for assessing the seriousness of adverse events.
    • Labelling Assessment: Learn to evaluate the relevance of labelling information to ICSRs.
    • Causality Assessment: Master the process of determining causality between a drug and an adverse event.
    • Narrative Writing: Develop clear and concise narrative reports.
  • Practical Case Scenarios:
    • Case Validity Examples: Analyze real-world examples of case validity assessments.
    • MedDRA Practical Application: Hands-on practice using MedDRA for coding and analysis.
    • Seriousness Assessment Case Studies: Work through case scenarios to practice seriousness assessment.
    • Labelling Assessment Case Studies: Apply your knowledge to evaluate labelling relevance.
    • Causality Assessment Case Studies: Practice causality assessment using various case scenarios.
    • Sample Narrative Writing: Review and learn from sample narrative reports.
  • Case Prioritization Rules: Understand regulatory authority submission timelines and prioritize cases accordingly.

Throughout the course, we'll regularly check for understanding to ensure you're grasping key concepts. This course is designed to equip you with the practical skills needed to excel in ICSR processing.