Stay ahead of regulatory changes with this specialized course on the FDA’s proposed amendments to drug establishment registration and listing. Designed for pharmaceutical professionals and regulatory teams, this course breaks down new pathways for registering distributed manufacturing establishments (DMEs) and clarifies requirements for foreign drug facilities under the PREVENT Pandemics Act. Learn how the hub-and-spoke model affects compliance, what’s required for supply chain visibility, and how to effectively prepare for implementation. Gain actionable insight on timely submissions, required information, and potential impacts on your business.
In this course you will learn the following:
* Explain the goals and rationale behind the proposed rule.
* Identify the new registration and listing requirements for distributed manufacturing establishments (DMEs) and foreign establishments.
* Understand the hub-and-spoke model of distributed manufacturing and its regulatory implications.
* Recognize the opportunities for public comment and the importance of stakeholder engagement.
* Anticipate how the proposed rule may evolve before finalization.
