Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance-Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products
Date and Time: Nov. 6, 8:30 a.m. to 5 p.m., Nov. 7, 8:30 a.m. to 4:30 p.m.
Co-Hosts: Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG)
Format: In-Person (Universities at Shady Grove; Rockville, Md.) and Virtual Workshop
This interactive two-day workshop will discuss the regulatory recommendations on confirmatory testing methods for the formation of Nitrosamine Drug Substance Related Impurities (NDSRIs), safety testing methods for NDSRIs, and recommended acceptable intake limits for NDSRIs.
The workshop will share the latest research and recommendations for detecting NDSRI formation as well as strategies to mitigate risks of their formation and ensure compliance with evolving regulatory requirements. Get up-to-date information on the latest guidance and recommendations on formulation stability and bioequivalence approaches, and hear firsthand from experts on regulatory approaches for pre- and post- approval changes in ANDA/NDA submissions and supplements.
This workshop is your opportunity to stay ahead of the curve, network with peers, and take away practical solutions to enhance your drug development and manufacturing processes.
Virtual attendees will enjoy free access to all workshop presentations and panel discussions. Virtual attendees will be able to:
- Attend all presentations and panel discussions
- Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
- Enjoy free access to workshop recordings of presentations and panel discussions
In-person attendees will enjoy all of the benefits of virtual attendees and will have networking opportunities with the speakers and panelists while engaging in active dialogue with the panelists. In-person attendees will be able to:
- Collaborate in person with FDA, industry, and academic experts throughout the workshop
- Enjoy priority over virtual attendees to ask questions to the panelist
- Engage in dialogue with attendees and faculty about the strategies to mitigate risks and ensure compliance with evolving regulatory requirements
- Talk with panelists during discussion panel Q&As
- Network with colleagues during breaks