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14
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Advanced Topics in Documents and Dialogues
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...
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16
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Advanced Topics in Manufacturing
Instructors: Abigail A Ekeigwe, mercy amaka okezue, Paddy Shivanand, Stephen Robert Byrn, Frances Eckenrode, MONICA E KOENIG
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5
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Innovation in Biotechnology
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...
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6
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Innovation in Regulatory Practices
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...
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15
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Foundations of Research in BIRS
Instructors: Abigail A Ekeigwe, mercy amaka okezue, Paddy Shivanand, MONICA E KOENIG, Frances Eckenrode
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7
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BIRS Orientation
Instructors: Kari Clase, Mary E Speer, Nicole K Zimmerman
Any information or updates for your BIRS Program will be posted here.
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3
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Regulatory Considerations for Drug Substance
Instructors: Kari Clase
Regulatory Considerations for Drug Substance (API) Dossier Submission and Review (for the MS students)
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2
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Global Drug Development
Instructors: Kari Clase
Global Drug Development with Considerations for Quality API Manufacturing and Regulation (for the new certificate students)
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