Best Strategies for Meeting US (IND through Post Marketing) Drug Safety Requirements Efficiently 2015 is a conference that covers topics such as:
- 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
Best Strategies for Meeting US (IND through Post Marketing) Drug Safety Requirements Efficiently 2015 brings together 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
