It’s been a while since the last blog update! I apologize, but I’ve been engaged in so much work on behalf of the PBOA — visiting Capitol Hill (repeatedly), hosting.
INTERPHEX Panel: Quality Agreements
Location: INTERPHEX Innovation Stage 2, Exhibit Hall The FDA is working on a Guidance detailing its suggested uses for Quality Agreements, the written agreements that define responsibilities for CMOs and.
INTERPHEX Panel: CDMO Executive Perspectives
Location: INTERPHEX Innovation Stage 2, Exhibit Hall In this PBOA-sponsored session, moderator Jim Miller (Founder, President of PharmSource) talks to a panel of top executives in the CMO/CDMO space. With.
INTERPHEX Presentation: The Road to the Biologic IND
Presenter: Michiel Ultee • Principal Consultant, Ulteemit BioConsulting, LLC Location: INTERPHEX Innovation Stage 2, Exhibit Hall The Biologic IND (Investigational New Drug) application is a critical, early milestone in evaluating.