Mitagation Strategy for NDSRIs (FDA & CRCG) Workshop

Next June 15th, FDA and Center of Research on Complex Generics (CRCG) is organizing a hybrid workshop on Mitigation strategies for Nitrosamine Drug Substance Ralted Impurities: Quality and Bioequivelance considerations for Generic Products

The purpose of this workshop is to discuss the risks of forming NDSRIs in certain drug products, strategies to mitigate these risks, and considerations in assessing the safety risks of NDSRIs. The workshop will also discuss approaches to prevent or mitigate the formation of such impurities, for example, by adding a suitable antioxidant and/or pH modifier to drug products. Finally, the workshop will discuss the potential impacts of such reformulation on the bioequivalence of generic products, and strategies to efficiently address these issues.

Session 1: Risk of Forming NDSRIs and Strategies to Mitigate the Risk

Session 2: Safety & Risk Assessment of NDSRIs for Human Health

Session 3: Impact of Reformulation on the Bioequivalence of Generic Products and FDA regulatory perspectives on reformulated generics

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You do not want to miss this event!! I’m looking forward to a great discussion (I’ll be in person!)

@trust_user_a @trust_user_b @trust_user_c

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Would love to attend in person, but it might just have to be the online version and a late night.

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We have additional details about the program:

Session 1: Risk of Forming NDSRIs and Strategies to Mitigate the Risk
This session will discuss the risk factors from both the API and excipients in the formation of NDSRIs, and analytical methods used in the quantification of N-nitrosamines in pharmaceuticals. The speakers and panelists will also discuss the strategies to control impurities during the synthesis of the API and excipients, and other strategies to prevent the formation of NDSRIs in a drug product during its shelf-life.

  • Presentations by experts from FDA and the generic drug industry
  • Audience Q&A with panelists from FDA and the generic drug industry

Session 2: Safety & Risk Assessment of NDSRIs for Human Health
This session will focus on considerations in assessing the safety risks of NDSRIs. The speakers and panelists will discuss current efforts, by both the FDA and drug manufacturers, to assess the potential risk of NDSRIs for human health and to predict the activity and potency of NDSRIs by utilizing quantitative structure–activity relationship (QSAR) models or other relevant quantitative tools.

  • Presentations by experts from FDA and the generic drug industry
  • Audience Q&A with panelists from FDA and the generic drug industry

Session 3: Impact of Reformulation on the Bioequivalence of Generic Products and FDA Regulatory Perspectives on Reformulated Generics
This session will focus on the potential impact of reformulations (e.g., adding a suitable antioxidant to the existing formulation) on the bioequivalence of generic products and strategies to efficiently address these challenges. The speakers and panelists will discuss current and future research efforts to evaluate the effect of an antioxidant in the formulation on the absorption and/or the bioavailability of API and to utilize modeling and simulation approaches to assess the risk of potential bio-inequivalent scenarios in the event of a reformulation. The speakers and panelists will discuss regulatory perspectives relating to potential bioequivalence approaches for generic products that are reformulated to mitigate NDSRIs formation.

  • Presentations by experts from FDA, academia, and the generic drug industry
  • Audience Q&A with panelists from FDA, academia, and the generic drug industry
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Hi Naiffer,
Hope you are doing well. This is great scientific forum and I find it very useful. I was hoping to get some input whether there are nitrosamine guidance documents out there from Health Authorities from Middle East countries (such as Kuwait, Bahrain, Saudi Arabia, UAE, Qatar) and from LATAM countries (such as Peru and Uruguay). If there are no specific guidance from these countries, is it possible to know if they follow any other guidance (such as EMA, FDA etc.). Will much appreciate any information. Thank you.
Regards,
Partha

Hi Naiffer - Both @conudel and I will also be participating in this meeting although attending remotely

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This is a really good question - tracking the various guidances that exist is a real challenge and therefore your question is a little difficult to answer in depth. Out of those listed i cannot personally find any record of specific guidance. Consequently I think it wise to adhere to FDA / EMA guidance. One thing though to pay attention to is timelines for Steps 1-3 this is where there is often local guidance

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Now youtube video is available. Let’s enjoy the excellent lectures.

Session 1-Part 1-Welcome, Intro, Talks

Session 1-Part 2-Talks, Panel

Session 2-Talks, Panel

Session 3-Talks, Panel, Closing Remarks

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Thanks for sharing. I kept checking

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Thanks for sharing the valuable files

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Workshop Recordings & PowerPoints from the sessions are now available at:
https://www.complexgenerics.org/NDSRIs_mitigation_strategies/

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