Early signal detection system for improved drug safety
Audit and inspection
Benefit risk analysis to characterize and capture drug profiles
Safety reporting for clinical trials and FDA final rule
Who should Attend
Regulatory agencies managers, Executive directors and specialists of: Ministry of Health (MOH), Food and Drug Administration (FDA) and Office of Adverse Drug Reaction (ADR) Reporting
Biotech and Pharmaceutical companies and CROs Managers, Heads and Specialists of: Drug Safety, Pharmacovigilance, Medical Safety/Medical Information, Regulatory Affairs/Compliance, Quality Assurance, Product Safety & Quality Management, Post-marketing surveillance, Clinical Operations and Signal detection
From Research Institutes and Medical Schools Heads of departments/professors