ISPE Aseptic Annual Conference


24 - 25 February 2014, Conference, Washington, DC, US

24 - 25 February 2014


Washington, DC, US

This conference will focus on the possible connection between drug shortages and the lengthy chemistry, manufacturing, and control (CMC) process; a description of key operational elements in manufacturing that appear critical to avoiding shortages will also be provided.

During the interactive portion of the session, Captain Valerie Jensen, Associate Director of the FDA’s Center for Drug Evaluation and Research’s (CDER’s) Drug Shortage Program, will join a panel hosted by ISPE for a question and answer session with the audience. Captain Jensen’s participation on the panel comes just four days after the release FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages.

Organiser: ISPE