Register for our webinar on Nitrosamine Control: Understanding the New FDA and EMA Regulations.

Starts

July 12, 2021
16:00

Ends

July 12, 2021
17:00

Location

Online

Nitrosamine impurities have been a pressing topic in the pharmaceutical world ever since their detection in a commonly used blood pressure medication in 2018. In the last three years, several regulatory warnings and product recalls have been issued due to contamination with this class of genotoxic impurities.

Global regulatory authorities, including the FDA and the EMA, have introduced major regulatory updates instructing all pharmaceutical manufacturers to conduct a risk assessment and proactively test their products for nitrosamine contamination.

As a result, marketing authorization holders of human medicines identified to be at risk of N-nitrosamine formation had until March 31 2021 to complete the risk assessment followed by confirmatory testing and submission of required changes by September 26, 2022 (EMA), October 1, 2022 (HC) and October 1, 2023 (FDA).

It is therefore crucial for pharmaceutical companies and manufacturers to get up-to-speed with these new requirements.

Objective

This webinar will provide a complete review of the recent regulatory changes on nitrosamines contamination in pharmaceuticals. We will also offer a comprehensive guide on testing best practices proposed in the USP <1469> and EP 2.5.42. chapters.

Agenda

  • Background on nitrosamine impurities
  • The updates introduced in the FDA and EMA regulations
  • Risk assessment and testing best practices
  • Walkthrough of compendial testing requirements
  • Q&A

Target Audience

Pharmaceutical companies, API manufacturers and regulatory professionals.

Speaker

Houri Simonian
Director of Analytical Operations

Houri Simonian, PhD, has over 20 years of experience in the pharmaceutical industry and specializes in R&D and drug development. She has been the Director of Chemistry for SGS Mississauga for the past six years, supporting customers in all related to drug testing and development.

For more information, please contact:

Aurelia Resines
Global Head of Marketing
t: +41 22 739 91 11