Advanced Topics in Manufacturing Course #16 Instructors: Abigail A Ekeigwe, mercy amaka okezue, Paddy Shivanand, Stephen Robert Byrn, Frances Eckenrode, MONICA E KOENIG
BIRS Orientation Course #7 Instructors: Kari Clase, Mary E Speer, Nicole K Zimmerman Any information or updates for your BIRS Program will be posted here.
Advanced Topics in Documents and Dialogues Course #14 Instructors: Abigail A Ekeigwe, mercy amaka okezue, Paddy Shivanand, Stephen Robert Byrn, MONICA E KOENIG, Frances Eckenrode Documents and Dialogues of Drug Development and Registration: This capstone advanced course will integrate previous learning relating to laws and regulations, quality principles and practices, and...
Foundations of Research in BIRS Course #15 Instructors: Abigail A Ekeigwe, mercy amaka okezue, Paddy Shivanand, MONICA E KOENIG, Frances Eckenrode
Global Drug Development Course #2 Instructors: Kari Clase Global Drug Development with Considerations for Quality API Manufacturing and Regulation (for the new certificate students)
Innovation in Biotechnology Course #5 Instructors: Kari Clase, Frances Eckenrode This course will focus on innovations in biotechnology that are driving the present product development environment from both a pharmaceutical product and device perspective. Our goal is to have...
Innovation in Regulatory Practices Course #6 Instructors: Kari Clase The focus of this course will be on GRP, systems mapping and evaluation. The goal is to have interactive sessions where students can apply the theory covered in the GRP (on-line) modules to case...
Regulatory Considerations for Drug Substance Course #3 Instructors: Kari Clase Regulatory Considerations for Drug Substance (API) Dossier Submission and Review (for the MS students)