Regulatory strategy is inherently linked to product development strategy and should be defined and revisited over the course of the development pipeline. Regulatory strategy should be built on relevant legislation, scientific guidance, regulatory precedent, and should be tailored to the product type, intended therapeutic indication, and the target pathway for registration.

During the webinar we share:

  • An overview of best practices for defining regulatory strategy
  • Approaches to regulatory interactions that optimize the likelihood of a harmonized global development plan
  • Insight into regulatory procedures that can expedite time to market

Watch the webinar to gain knowledge of regulatory strategy, scientific advice interactions, and regulatory pathways, as well as an understanding of the benefits of regulatory procedures in regulatory strategy and how this can optimize product development.

This webinar was originally recorded November 16, 2022 and is co-presented with Scendea.