Abstract Submission

Be a thought leader at E&L USA 2024!

In addition to our invited speakers we ask industry thought-leaders to submit presentation abstracts that detail ideas, advancements, and emerging opportunities. If you would like to inspire discussion and development as a thought leader, we want to hear from you! Presenting is a key way to put yourself and your company at the forefront of the industry, and to connect with other top players.

Topics of interest include, but aren't limited to:

  • Regulatory Updates
  • Expectations/guidance: biocompatibility, devices/combination products, manufacturing
  • ICH Q3E, USP, PQRI, etc.
  • Regulatory product submission challenges & outcomes from company perspective
  • ISO Part 18, expectations and challenges
  • ISO Part 17, expectations and challenges
  • Analytical Chemistry and overcoming analytical challenges
  • Challenges Faced in E & L experiments Vs. Guidelines Compliance
  • Navigating challenges with greatly accelerated development, manufacturing, and deployment of biologics for urgent medical needs
  • Approaches to achieving lower thresholds
  • Data on Leachables
  • Medical Device & Drug Device Combination Products - 3D printed and personalized
  • Standardized & company-specific risk assessment approaches for all dosage forms
  • Technical advances and novel approaches to E&L
  • The differences between ISO 10993 (Medical Device) and USP <1663> and <1664> (Combination Drug Product).
  • Case Studies that present data obtained
  • Different leachables risk for production components/systems during production

Submit this form and we will be in touch!

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