Title : The importance of post-marketing surveillance and real-world data: For a product to be successful
Abstract:
Why is Post-Marketing Surveillance and Real-World Data important for the success of your product? Post-Marketing Surveillance or Phase IV is required by the FDA after the product is approved and launched. Phase IV is mainly focused on pharmacovigilance, drug safety and reporting adverse events to the FDA. Unfortunately, once the product is approved, physicians are generally not required to report adverse events to a national registry, except for specific cases like adverse events to vaccines and serious injuries or deaths related to medical devices. This is a problem in collecting Real-World Data that can provide critical insights into long-term safety, effectiveness, and population-level impact to name a few. This session will cover why Post-Marketing Surveillance and Real-World Data is needed and how it can validate your product. I will cover the top five (5) reasons you need Post-Marketing Surveillance plus gather, monitor and analyse Real-World data and the tools to capture this data to enhance your product marketing strategies for commercial success.
- Clinical Trials (controlled environment) vs. Real World (Wild Type)
- Clinical Trials (Homogenous) vs. Real World (extremely Heterogenous)
- Clinical Trials (adverse report) vs. Real World (under reporting, lack of information)
- Need for long-term data
- Serendipitous or repurposing
In capturing Real-World Data, electronic health records, wearable technologies, and mobile health apps have revolutionized how real-world data are collected and analyzed. AI can also aid in gathering and analyzing this data.
