How does the FDA actually make decisions? What are the red flags reviewers look for in submissions? This workshop gives you insider decision-making logic internal to the FDA. Walk away with the confidence knowing your regulatory program is on the right track.

You will leave with:

• How FDA approaches sponsor interactions

• Reviewer decision-making logic specific to your product

• Answers to your specific challenges (bring your questions, we’ll build a solution around your product)

About Laura:

Laura is a former FDA Associate Director who spent almost 8 years in the agency. She brings comprehensive FDA regulatory knowledge across CBER, CDER, and CDRH, specializing in regulatory science & regulatory strategy for combination products & devices. Prior to FDA, Laura earned her PhD in Biomedical Engineering and gene therapy, and was a co-investigator for a Cell Therapy Clinical Study at Johns Hopkins University

Virtual event, link provided upon confirmation

FDA Insider Workshop is an interactive workshop series on Regulatory, CMC & Raw material topics that are critical for life sciences teams preparing or in clinical trials.