Event
Course description:The Pending Monograph Process (PMP) is a successful collaboration developed between the USP and FDA to allow monograph revisions to address potential non-conformance with applicable USP standards noted during drug approval process. This webinar is designed to address how and when to apply for the PMP, what to expect in the process, how the PMP fits into the drug approval timeline, how to determine if your organization qualifies for the PMP and more. There will also be a live Q&A with the presenters to answer questions not addressed during the presentation.
Upon completion of this course, you will:
- Understand the purpose of the Pending Monograph Process
- Be able to submit requests for revision using the PMP
Who should participate:
- Regulatory compliance personnel and management
- Compendial affairs specialist
- Regulatory affairs specialist
- Generics manufacturers
- Veterinary manufacturers
- Individuals and companies interested in monograph revision process via the Pending Monograph Process