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.
SUBMISSION DEADLINE: TBA
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