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  4. Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products - 11/06/2024
  1. News & Events for Human Drugs

Workshop | Mixed

Event Title
Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products
November 6 - 7, 2024


Date:
November 6 - 7, 2024
Day1:
- ET
Day2:
- ET

Location

The Universities at Shady Grove
Building II
9630 Gudelsky Drive
Rockville, MD

About the Event:

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 NDSRIs 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 submission and/or 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 discussion (not including the working sessions)

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 panelist. 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
  • Converse with panelists during discussion panel Q&As
  • Network with colleagues during breaks

For more information: https://www.complexgenerics.org/education-training/updates-on-approaches-to-acceptable-intakes-of-nitrosamine-drug-substance-related-impurities-ndsris-and-bioequivalence-assessment-for-reformulated-drug-products/

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