Be a thought leader at E&L USA 2022!

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.

SUBMISSION DEADLINE: December 17, 2021

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

• Regulatory Updates
• Expectations/guidance i.e. biocompatibility, devices/combination products, manufacturing
• ICH Q3E, USP, PQRI, etc.
• Regulatory product submission challenges and outcomes from company perspective
• ISO Part 18, expectations and challenges
• Analytical Chemistry and overcoming analytical challenges
• 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- including 3D printed and personalized
• Standardized and 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
• Expectations for medium/low risk dosage forms

Submit this form and we will be in touch!