The Clinical Development Online Certificate Program provides a self-paced online program to professionals working in science, healthcare, technology or management. The program offers seven courses on drug, biologic and device development regulatory issues and practical knowledge. Students can complete individual courses or the full certificate program in five to eight months. The certificate program costs $2,065 plus a $50 fee and provides 8.4 continuing education units upon completion.

1. 2016SF STATE
EXTENDED LEARNING
Clinical
Development Online
Professional Development Certificate Program
The Clinical Development
Online Certificate Program,
launched in 2011, offers a
self-paced learning format
and online meetings with
industry expert instructors that
provide the knowledge needed
in drug, biologic and device
development careers.
Overview
The Clinical Development Online Certificate Program provides students with an
understanding of drug development regulatory and compliance issues in the
pharmaceutical and biotech industries. The comprehensive program reviews
current regulations, guidelines and common practical issues. During each course,
an industry expert is scheduled to answer student questions. All courses are online
and self-paced. Students may take individual courses or take all seven to earn the
certificate.
Intended Audience
Students in this program are professionals, often with related experience, working
in science, health care, technology or management.
Program Objective
• Provide drug, biologic and device development knowledge through a fully
online and self-paced educational format
Cost and Length of Study*
The certificate consists of seven courses.
The certificate costs $2,065, plus a $50
certificate fee. The cost is calculated on
a per-course basis, with all materials
available online.
Students have one month to complete
each self-paced course and can
complete the certificate in five to eight
months.
*Subject to change

2. Clinical Development Online
Curriculum*
Course # Required Courses
IT 9532 Overview of Drug/Biologic Development (prerequisite) or
Overview of Device Development (prerequisite; only offered in spring)**IT 9533
IT 9531 Introduction to Regulatory Affairs (US)**
IT 9541 Good Clinical Practices (GCP)
IT 9542 Good Laboratory Practice (GLP)**
IT 9543 Current Good Manufacturing Practices (cGMP)**
IT 9538 Biostatistics for Nonstatisticians
IT 9539 Safety Monitoring**
*Subject to change
**These courses are applicable to the Clinical Trials Design and Management Certificate
Program as electives.
Professional Credit:
Continuing Education Units
Credit is recorded as continuing
education units (CEUs), which provide
a standard of measurement for
nondegree educational experiences.
CEUs cannot be applied to a degree.
The certificate is 8.4 CEUs.
Admissions
There is no formal application or
admissions process for these courses.
Interested students simply register and
pay for courses they wish to take.
Requirements
There are no formal requirements or
prerequisites to fulfill prior to enrolling
in courses for the certificate program.
“I am really loving these courses and
this program! So interesting! I love
the fact that it is so flexible. I have
two small kids and work full time, so
whenever I do have time, I squeeze in a
section or two. Thanks!”
– Kristine A.
Clinical Development Online Student
“I love the course and the format. … It’s been really enlightening. I’ve learned so
much and it’s filled in many missing pieces that I’ve always wondered about.”
– Wendy B.
Clinical Development Online Student
Cathy Flight, program director | 415.817.4226 | cflight@sfsu.edu
Paloma Mathern, program coordinator | 415.817.4232 | pmathern@sfsu.edu
cel.sfsu.edu/clinicalonline
835 Market Street, 6th floor
Above Powell St. BART/Muni
cel.sfsu.edu
415.405.7700
CEL12.2015