Best practices for setting up reliable safety reporting systems internationally, when the US/FDA is just one part
What safety information FDA wants and when
What FDA is looking for in safety reporting and what are red flags for FDA that you want to avoid
Prepare concise and accurate safety reporting documents required at any stage of drug development in the US
Who should Attend
Attendees involved or interested in:
Submissions Medical Writers and Editors
Human Safety/Pharmacovigilance Staff
Regulatory Affairs
Clinical Operations
Project Managers
Regulatory Operations
US Agents
Data Management
Process Owners
Compliance Professionals
Document Control Specialists
Past Events
Best Strategies for Meeting US (IND through Post Marketing) Drug Safety Requirements Efficiently 2015 - 15-16 Oct 2015, Grand Hyatt San Francisco, California, United States (54010)
Important
Please, check "Best Strategies for Meeting US (IND through Post Marketing) Drug Safety Requirements Efficiently" official website for possible changes, before making any traveling arrangements
