How to write an individual case narrative, assess causality and expectedness of cases, and determine certainty of diagnosis according to Brighton collaboration guidelines.

• Introduction to clinical safety, Pharmacovigilance and benefit-risk management

  Clinical safety in the Developing World

  Statutory basis for safety in humans:

  • Historical basis - Governing bodies and Health Authorities: ICH, Council for International Organizations of Medical Sciences (CIOMS), WHO - Safety data collection in clinical trials - Spontaneous adverse events 
  Adverse Events:
  • Definitions and classification - Processing, archiving and retrieval - Assessment: expectedness, listedness, causality and reference documents - Analysis and decision-making - Regulatory Reporting
  Life-Cycle Clinical Product Safety:
  • Discovery and pre-clinical science
  • Pre and post authorization clini cal safety
  • Structured benefit-risk assessment and management
  • Safety strategy,  issue management and crisis prevention
  • Communication in Pharmacovigilance