Head of Medical Affairs
Main Conference Day One
Wednesday, June 10th, 2020
12:25 PM Post Market Safety Reporting for Combination Products: Implementation Challenges and Proposed Solutions
- What is Post Market Safety Reporting: Streamlining and reducing unnecessary reporting and improving the quality of reports
- What are the biggest challenges associated with ensuring compliance?
- What are the unique reporting requirements?
- Guidance on how to comply with the final rule: Effectively planning to adequately address adverse events