Informa

29-30 June 2021


Industry Landscape


Nitrosamines, or more correctly N-nitrosamines, refer to any molecule containing the nitroso functional group. Thesemolecules are of concern because nitrosamine impurities are probable human carcinogens. Although they are alsopresent in some foods and drinking water supplies, their presence in medicines is nonetheless consideredunacceptable.

To ensure the safety of the U.S. drug supply, FDA has launched the availability of a guidance for industry, entitled“Control of N-Nitrosamine Impurities in Human Drugs.” This guidance recommends steps manufacturers of activepharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamineimpurities in pharmaceutical products. The guidance also describes root causes that may introduce nitrosamineimpurities.

The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during themanufacture of human medicines and has provided guidance to marketing authorization holders to avoid the presenceof nitrosamine impurities. EMA finalized a review under Article 5(3) of Regulation (EC) No 726/2004 in June 2020 toprovide guidance to marketing authorization holders on how to avoid the presence of nitrosamine impurities in humanmedicines.Companies are required to have appropriate control strategies to prevent or limit the presence of these impurities and,where necessary, to improve their manufacturing processes. The 2nd edition of Nitrosamine Impurities Forum scheduled on 29-30 June 2021 will discuss on the current challenges & future perspective.





Why this forum?

The second edition of Nitrosamines Impurities Forum will focus on the challenges to any molecule containing the nitroso functional group while discussing on the below:

Understanding current regulatory requirement to tackle with Nitrosamine Impurities concerns
How to calculate & derive on acceptable intake limit
Gain clarity on choosing correct analytical methods & tools to address these impurities
How nitrosamines are formed – Chemical mechanism behind this
How to stop condition reaction of forming nitrosamine impurity
How to restrict these impurities at the process or R&D stage

Speakers

Who Should Attend

Industries

Pharmaceuticals

Life sciences

Bio-Pharmaceuticals

API Manufacturers

Departments
Quality Assurance
Quality Control
R&D
Production & Manufacturing
Analytical
Packaging
Regulatory


Designation
Vice Presidents
Associate Vice Presidents
Directors
Associate Directors
Head/ Plant Heads
Deputy General Managers
General Managers
Senior Managers
Managers
Assistant Managers
Senior Executives

Who should Partner?



Analytical equipment providers

  • GC-MS -MS
  • LC-MS-MS
  • Orbitrap
  • HPLC-MS
  • Nitrogen Chemiluminescence Detector
  • Small benchtop instruments

Industry experts assisting pharmaceutical industry through all the steps of investigation from risk assessment to analytical methods in order to confirm the levels of nitrosamine impurities in drug substances and drug products.

  • Chromatographic Columns
  • Filters
  • Chemical and AR-Grade Standards
Testimonials

What Clients Say