9.00-12.00 Workshop A
Achieving the Regulatory GRAS Status with Optimal Review of Safety & Data Generation
Synopsis
The journey to regulatory approval can sometimes seem like a never-ending and complex labyrinth. Cross-departmental collaboration with regulatory decision makers will help you bridge this gap and help exercise the skills that are in your control.
Join this workshop to unite with industry-leading regulatory experts to understand the ins and outs of pre-submission meetings and regulatory frameworks to streamline approval.
This workshop will gather experts to discuss:
- Outlining and assessing GRAS notices to help inform review of safety and identify early market opportunities for specific bioactives
- Pin-pointing nuances in data quality to best prepare for pre-submission meetings and effectively demonstrate growth and intake outcomes
- Implementing risk-benefit models for regulatory strategies to compare alternatives and hone in on best directions forward
1.00-4.00 Workshop B
Perfecting Your Experimental Design to Inform Early Decision Making & Future-Proof Business Strategy
Synopsis
As the journey towards regulatory acceptance and commercialization stems from experimental data, it’s imperative to set up fit-for-purpose experimental designs to secure your forward strategies.
Join this workshop alongside research wizards who have all the experimental know-how to help you adapt experimentation and inform preclinical and clinical decision making.
This workshop will gather experts to discuss:
- Assessing public perception surrounding preclinical models to learn how to justify model of choice
- Broadening the scope of your preclinical trials in light of clinical limitations to best predict efficacy effects on infants
- Delving into demonstrations of bioefficacy to effectively translate to internal and external team
Download the Full Event Guide to Discover:
- 16+ expert speaker faculty
- 3 days of data-driven case studies
- 60+ visionaries
- & more
