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 FDAnews webinar, 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.

Webinar 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.

Who Will Benefit:

  • Drug, medical device and combination product manufacturers 
  • Quality assurance staff
  • Regulatory affairs staff
  • General counsel