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Abstract Submission

In addition to our invited speakers, we're looking for dynamic presenters to speak at the conference with abstracts detailing extractables and leachables advancements, case studies, product developments and more!

If you would like to inspire discussion and development, we want to hear from you! Presenting is an ideal way to position you and your company as E&L thought leaders with a pulse on the industry.

For any questions or concerns, please feel free to contact Sandra Haines at shaines@smithers.com.

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

E&L US Abstract Submission

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