Tom Cosgrove, Partner in Food, Drug and Device Group, Covington & Burling LLP:
The presentation will be discuss the practical and legal implications of the disruptions to regulatory inspection activities caused by the COVID pandemic. The discussion will focus on how FDA is adjusting its inspection and review activities, how manufacturers and sponsors are adjusting, and the potential long-term implications on the drug development pipeline.
Andrei Spinei, Scientific Administrator, European Medicines Agency:
The EMA has conducted a review of human medicines with nitrosamine impurities setting out recommendations on mitigating the presence of nitrosamine impurities in human medicines. There is an ongoing call for review at EU level for nitrosamine impurities in all human chemical and biological products, where marketing authorisation holder are requested to review and assess their products and report the outcome and register changes to their products to mitigate any confirmed risk. Further detailed guidance on implementation of the EMA recommendations for authorised products as well as for new/ongoing applications as well as the call for review is available on the EMA website.