Andrey Sarafanov

Company: FDA

Job title: Principal Investigator & Head of Research Laboratory

Seminars:

Regulatory Insights into the Evaluation of Extractables in Biologic Therapies: FDA Perspectives & Case Studies 9:10 am

Overview of FDA methodologies for identifying and assessing extractable substances in biologic drug packaging and delivery systems Common challenges and considerations when interpreting analytical data during regulatory review Case examples highlighting FDA’s decision-making process and expectations for supporting dataRead more

day: Conference Day One