505(b)(2) Right-First-Time Strategy for Today's FDA

​Presenters:

Jennifer DiGiacinto, PharmD

Jim Schwier

Edward J. Allera. Esq.

In times of regulatory uncertainty, getting things right the first time is crucial. Join us for an insightful webinar where Jennifer DiGiacinto will reveal how study design issues can lead to unrecoverable setbacks, and Jim Schwier will share how even the gold standard approach can face project challenges.
Discover their compelling case study on transitioning from a failing program to a successful recovery, ensuring FDA approval. Learn about the innovative parallel pathway approach, strategies for handling unexpected SAE’s, and achieving a successful conclusion.
Don't miss this opportunity, view the video and gain valuable insights and practical solutions to navigate regulatory complexities and drive your projects to success.
Thanks to our webinar sponsor RRD Biopharma Development