Clinical Trials Quality & Inspection Updates is dedicated to this practical course provides an in-depth understanding of latest GCP requirements and its practical implications.
Topics
Clinical Trial risk-based approach - implementation & best practices
Major developments in GCP and practical implications
Sponsor oversight
GCP inspections: hot topics, outcomes and practices (MHRA/EMA/FDA)
Data integrity in clinical trials
Clinical Trial Risk Management
Practical implementations of major developments in GCP
Risk assessment tools and best practices
Quality Tolerance Levels
GCP inspection outcomes and practices (MHRA/EMA/FDA)