Document Submission

Rate This Document

HeLD of Syringe systems (pdf)
Download (1461 KB)
Opening Plenary, Dolores Hernan, EMA (pdf)
Download (702 KB)
Ronald D. Gunn, MS, MBA and Gregory L. Tewalt, PhD (pdf)
Download (786 KB)
CMO Presentation_Carmelo Rosa (pdf)
Download (535 KB)
The Regulatory Hurdles and Challenges for Post Approval Changes of Legacy (Existing) Products (pdf)
Download (584 KB)
FDA Guidance for Industry Good Manufacturing Practices for Combination Products 27 Apr 2015 (pdf)
Download (654 KB)
Wenzel Novak - groninger & co. gmbh (pdf)
Download (4760 KB)
Reference 3 - Pre-BLA CMC Guidance Zynlonta ADC (pdf)
Download (855 KB)
Cylia Chen-Ooi (pdf)
Download (1156 KB)
4_Parisse-Jean-Sebastien (pdf)
Download (1245 KB)
Donald B. Ertel (pdf)
Download (196 KB)
P2Goddard (pdf)
Download (7043 KB)
Attendee List with Consent (pdf)
Download (193 KB)
Supplier_presentation_Optical Emission Spectroscopy (pdf)
Download (1975 KB)
Valerie Jensen (pdf)
Download (881 KB)
Suzette Roan (pdf)
Download (1400 KB)
March 2004 (pdf)
Download (1536 KB)
Gerald Leister (pdf)
Download (1133 KB)
4_Zeiss_Pietarinen (pdf)
Download (1420 KB)
Risk Based Environmental Monitoring (EM) and EM Data Management and Trending (pdf)
Download (1846 KB)