UCSF

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

  • Regulatory framework

  • Mission and organization

  • Classification of medical products: Drugs, Devices, Biologics, Combination products

  • Regulatory submissions

Regulatory and scientific considerations for development of FDA-regulated medical products

  • Medical product development life cycle

    • Drug development
    • Medical device development
    • Development of biologics

Preclinical development

  • Regulatory toxicology and pharmacology

Clinical development

  • First-in-human studies

  • Clinical trials

  • Biomarkers

Postmarketing activities

  • Adverse event monitoring

  • Advertising and promotion

  • Manufacturing

Quality Systems

  • Good Practices GLP, GMP, GCP

  • Quality Systems

  • Regulation Quality by Design

For inquiries, please, contact [email protected]