Systematic Approaches for FDA Investigational New Drug Applications and Safety Reporting Submissions
With the recently released Final Rule for IND Safety Reporting Requirements, it is critical for industry sponsors to begin implementing systematic approaches to detect and report serious and adverse reactions for the enhanced safety of patients in clinical trials. Join us at CBI’s Pharmacovigilance Final Rule Summit on IND Safety Reporting to demystify this final rule, learn to accurately and rapidly report to the FDA, minimize uninformative reports and enhance the reporting of meaningful and interpretable information.
Benefit from Hard-Hitting Presentations and Networking with Industry Leaders to:
- Demystify the recently released Safety Assessments for IND Safety Reporting in order to fully grasp FDA expectations for AE submissions
- Analyze all 5 steps in the submission process to streamline your safety report approval process
- Benchmark against leading companies and hear how each one has tackled the complex challenges of IND safety reporting
- Develop a post-submission safety surveillance plan in order to maximize safety outcomes in a given study