PBOA
This free, members-only workshop in Washington, DC will cover legislative and regulatory topics critical to CMOs and CDMOs. Speakers will include both FDA and industry experts, and each presentation will be followed with time for Q&A.
PBOA will have a booth at INTERPHEX 2015! Please contact us to set up an appointment. PBOA is also sponsoring several sessions at INTERPHEX: The Road to the Biologic IND CDMO Executive Perspectives Quality Agreements Panel Many of our member companies will be exhibiting at INTERPHEX: PBOA - Booth 1044 AAI Pharma Services / Cambridge.
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.
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.
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?.