CERSI Immersion Program
Six full days of intensive coursework, followed by group discussions and networking. Enrollment is limited and by application only. Upon successful completion of the course, students may be recommended for CERSI internships or fellowships.
Application Process and Dates
General audience deadline: December 15, 2017.
Selection and notifications of acceptance: December 22, 2017.
Registration and payment deadline: January 25, 2018.
Registration fees (include six days of coursework at Stanford University as well as course materials):
Individual enrollments:
$6,000 per person if registered by January 25, 2018
$7,000 program tuition per person after the deadline
Group enrollments (teams of 3 or more):
$5,750 per person, if registered by January 25, 2018
$6,000 program tuition per person after the deadline
To apply: click here to submit your online application
Spring 2018 Agenda: April 2 - April 19, 2018
Introduction to U.S. Food and Drug Administration
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Regulatory framework
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Mission and organization
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Classification of medical products: Drugs, Devices, Biologics, Combination products
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Regulatory submissions
Regulatory and scientific considerations for development of FDA-regulated medical products
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Medical product development life cycle
- Drug development
- Medical device development
- Development of biologics
Preclinical development
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Regulatory toxicology and pharmacology
Clinical development
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First-in-human studies
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Clinical trials
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Biomarkers
Postmarketing activities
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Adverse event monitoring
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Advertising and promotion
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Manufacturing
Quality Systems
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Good Practices GLP, GMP, GCP
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Quality Systems
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Regulation Quality by Design
For inquiries, please, contact [email protected]