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.
The live version of this recording took place on October 22, 2020.
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
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
USP Approved Instructor
Amber Day
Program Manager, Standard Operations in USP’s Volunteer and Compendial Operations Department
FDA Speaker
Lana Bruney, PhD, MHA
Pharmacologist, Center for Drug Evaluation and Research Policy Lead, Office of Policy for Pharmaceutical Quality Compendial Operations & Standards
U.S. Food and Drug Administration