Postmarket Surveillance in the Real World: The FDA’s Perspective on RWD/RWE – Webinar Recording/Transcript
Product Details
Real-world data (RWD) and real-world evidence (RWE) can be valuable assets in complying with the FDA’s current focus on postmarket surveillance. In a series of guidances released late last year, the agency teased out how manufacturers of drugs, biologics, medical devices and combination products can harness RWD during the postmarket stage, converting the data into evidence to inform the FDA’s regulatory decisions.
This presentation, presented by former FDA compliance specialist and regulatory, clinical and market-access expert Jonathan Helfgott, will untangle these guidances, offering new ways to unlock the value of RWD and RWE.
Presentation Takeaways:
- Examine the FDA’s expectations for postmarket surveillance.
- Understand ‘fit-for-purpose’ considerations for RWD/RWE.
- Dig deep into case examples of the use of RWD/RWE.
- Gain a deeper understanding of the documentation needed for inspection readiness.
Use this opportunity to learn how best to establish a postmarket surveillance strategy that goes beyond compliance and adds value to your assets.
Meet Your Presenter
Jonathan Helfgott is an FDA regulatory, clinical and market access expert specializing in the commercialization of medical products at all phases of development. He worked at the FDA from 2006 to 2015, ultimately serving as the Associate Director for Risk Science within CDER’s Office of Scientific Investigations. He previously served as a compliance officer and premarket reviewer at CDRH.
Helfgott serves as faculty, senior lecturer and coordinator for Johns Hopkins University’s Regulatory Science and Food Safety Regulation Programs. He also serves as the president of the Association of Graduate Regulatory Educators and has lectured extensively at various other academic institutions and professional organizations.
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Who Will Benefit
- Drug, medical device and combination product manufacturers
- Quality assurance staff
- Regulatory affairs staff
- General counsel