Why Should You Attend:
Valsartan, Losartan and Irbesartan drug products have recently been recalled due to the presence of the carcinogens N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA). These carcinogens were found to be present above the low interim specifications recently established by FDA. The analytical method used to find these substances will be discussed. The public information about how they got into these drug products, and its implications for the future, will be considered. European Medicines Agency position on nitrosamines will also be presented.
All pharmaceutical manufacturers, both prescription and over-the-counter, should monitor the regulatory agencies actions regarding nitrosamines in sartans and consider the implications for other possible toxic impurities.
Areas Covered in the Webinar:
Who Will Benefit:
Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She participated in the development of method validation requirements for HPLC analytical methods. She then transitions to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.
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