Nitrosamines - New Requirements To Evaluate Contamination Risks

Watch this webinar to learn:

• The background of nitrosamine contamination incidents
• Regulatory actions related to nitrosamine risk assessment
• New requirements for evaluating nitrosamine contamination risks

Detailed Description:
Nitrosamine contamination has led to the recall of hundreds of batches of APIs such as valsartan, pioglitazone, and ranitidine, as these impurities are classified as probable human carcinogens. In response, regulatory authorities worldwide have implemented corrective and preventative measures to address these risks.

The European Medicines Agency (EMA) and the FDA have issued guidance to marketing authorization holders and manufacturers on preventing nitrosamine impurities in human medicines. This webinar will provide an overview of the latest regulations and requirements for evaluating contamination risks related to nitrosamines.

Speaker:
Ulrich Reichert
Global Regulatory Management, Life Science

Dr. Ulrich Reichert is a trained pharmacist with a Master's Degree in Drug Regulatory Affairs. With 20 years of regulatory and quality experience in pharmaceutical and food materials, he leads the Pharma and Food Materials group in Regulatory Management. Dr. Reichert also heads the nitrosamine working group within the Life Science sector of the company, plays a key role in the IPEC Europe nitrosamine task force, and is a member of the APIC nitrosamine task force.