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 our first Regulatory/Legislative Workshop, exhibiting at (and putting panels together for) INTERPHEX, preparing for the upcoming GDUFA public hearing, conducting our Q1 board meeting, visiting our member companies.
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 their clients. This panel, moderated by Alan Minsk (Partner, Arnall Golden Gregory) will discuss approaches and best practices regarding Quality Agreements. What are they for?.
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 expertise ranging from small molecule dosage form to biologic-APIs, and scale from single-site to global networks, the Executive Perspectives panel covers the gamut of the.
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 the safety and efficacy of a potential new biopharmaceutical. An approved IND allows a sponsoring company to take the next step in developing its product.