Understanding the Evolving Extractables & Leachables (E&L) Regulatory Expectations to Circumvent Drug Product Approval Delays

Time: 12:30 pm
day: Day One


  • Highlighting potential drug-device interactions early on in development to reduce risk and achieve the best possible outcome
  • Exploring E&L testing and analysis to quantify and assess risks associated with leachable impurities
  • Reviewing regulatory requirements within Extractable & Leachable testing for combination products