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Recorded Webinar
FDA and Safety Monitoring
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Safety Monitoring: My team was one of the first to pioneer pharmacovigilance and safety monitoring best practices under the Risk Management domain; which have being widely adopted across the industry. By now the FDA has embraced Safety Monitoring by setting out guidance for greater real time reporting and engaging patients directly into reporting Adverse Events (AEs).
Will discuss the process, technology and training required to meet Safety Monitoring standards. The increasing FDA interest in Social Media self reporting through tweeter vs. reporting through traditional channels. Lessons from the intelligence community applied to the pharma and medical device surveillance program. Finally the steps for setting up a comprehensive Key Risk Indicator tracking system that streams data from multiple safety monitoring systems. Ultimately having a unified regulatory strategy in where Safety Monitoring is the tip of the spear continuously increasing safety and efficacy.
The presentation will cover the following areas
- Guidance for Clinical Investigations using a Risk –Based Approach to Monitoring
- Increased requirements or cardiac and respiratory safety across all therapeutic application drugs
- Process and technologies geometrically expanding FDA expectations for early signal detections
- Incorporating Safety Monitoring in your operations
- Consistently improving your results and targeted outcomes
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