Abstract Submission

Become a thought leader at E&L USA 2025!

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.

The call for papers deadline is January 17, 2025Topics 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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