Be sure to follow our Twitter feed from this year’s PDA-FDA Joint Regulatory Conference, taking place in Baltimore.
Be sure to follow our Twitter feed from this year’s PDA-FDA Joint Regulatory Conference, taking place in Baltimore, at Twitter@PharmTechAngie or Twitter@PharmTechGroup. Today’s sessions focused on common regulatory citations (the word is that they haven’t changed much in the past 10 years), new ways to handle internal investigations from Big Pharma organizations such as Amgen and Abbott (including a bit of an audience stirup surrounding the management, or lack thereof, of Class I investigations), FDA encouragement of sending novel excipients in for review, best practices for selecting excipients for new drugs (including how to best deal with suppliers), updates on ICH Q11, and a lot of information on knowledge management, risk-based approaches (including QbD), and lifecycle approaches. More information to come tomorrow when the various FDA offices give their reports.
