Trainings By Informa Markets

Nitrosamine Impurities Summit

11 Jun - 12 Jun 2024

Workshop Overview

Dr. Raphael Nudelman

Nitrosamines, or more correctly N-nitrosamines, refer to any molecule containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens. Although they are also present in some foods and drinking water supplies, their presence in medicines is nonetheless considered unacceptable. To ensure the safety of the U.S. drug supply, the guidance recommends that manufacturers should conclude the risk assessment of approved or marketed products, the first of three steps manufacturers should follow to mitigate nitrosamine impurities in their products, within 6 months of publication of the guidance. FDA has launched the availability of a guidance for the industry, entitled “Control of N-Nitrosamine Impurities in Human Drugs.” This guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities. The Nitrosamine Impurities Forum scheduled on 11th and 12th June 2024 will discuss the current challenges & future perspectives.

Program Focus

  • Understand current regulatory requirement to tackle with Nitrosamine Impurities concerns
  • Deal with nitrosamine drug substance related impurities (NDSRIs)
  • Gain clarity on choosing correct analytical methods & tools to address these impurities
  • Understand the need gap between industry & regulators on analytical test & other safety test
  • USP’s Role & Updates to deal with Nitrosamine Impurities

Who Should Attend?

  • Pharmaceuticals
  • Life sciences
  • API Manufacturers
  • Bio Pharmaceuticals

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