Early Regulatory Strategy: Early Regulatory Interactions and Accelerated Programs Integration in your US/EU Development Plan
Published on: Dec. 10th, 2025
Bringing a new therapeutic product to market in the US and Europe involves a complex, multi-year process that spans from initial discovery through regulatory approval and commercial launch. As drug development becomes increasingly specialized, it is important to recognize that regulatory strategies are not one-size-fits-all. What works for one program, even within the same indication, may not be applicable to another, and this variability extends across geographic regions as well. It is important that companies align clinical development milestones with regulatory opportunities to optimize timelines, reduce risk, and accelerate patient access to innovative therapies.
In this webinar, VCLS regulatory science experts outlined how to strategically incorporate early regulatory interactions and expedited development pathways into drug development plans for the US and EU. They highlighted the importance of initiating timely engagement with regulatory agencies and outline the key expedited programs available, both in the US and EU along with some decision criteria to assess best timing for application.
SAMPLE OF THE WEBINAR
FEATURED SPEAKERS
Laurie Jullien, Pharm D
Director, Regulatory Science
Mamta Puri-Lechner, PhD.
Director, Regulatory Science