SPRING - UCSC Extension Silicon Valley

Electronic Data Capture
for Clinical Trials
NATSC.X400.036 (1.0 quarter unit) CA BRN/LVN Credit—
Provider #CEP13114, 10.0 hours.
This course takes a practical approach, by examining key
issues surrounding the industry’s adoption of electronic
data capture (EDC). The instructor highlights the major
differences between paper and electronic systems;
explores benefits associated with EDC; and systematically
examines the costs, risks, related process changes, and
other business and regulatory implications of this shift.
Interactive discussions address the process of selection,
implementation and maintenance of EDC software,
both for in-house and outsourced systems.
The course benefits professionals with roles in
data management, biostatistics, clinical management,
and clinical IT and IS.
JEFFREY SONAS, B.S.
SANTA CLARA LAB WITH ONLINE MATERIALS
2 meetings: Friday, 6–9:30 pm, March 2;
Saturday, 9 am–4:30 pm, March 3.
Fee: $580 ($58 discount for early enrollment).
To enroll, use Section Number 20777.(005)
Electronic Records for
Regulated Environments: Cost-Effective
Approaches to Compliance
For course description, see page 18.
Global Conduct of Clinical Trials
NATSC.X400.038 (1.5 quarter units) CA BRN/LVN Credit–
Provider #CEP13114, 15.0 hours.
Using the U.S. and E.U. as points of reference, the
instructor and guest speakers help students develop
a framework by examining issues and challenges related
to the conduct of clinical trials in established and emerging
foreign markets, including Eastern Europe, India, China,
and South America. Lectures and case studies explore
the current regulatory environment; the impact of local
laws and requirements; cultural challenges and procedural
differences in trial conduct; how to ensure that useful
data are collected; and important implications for human
subject protection.
Prerequisite(s): “Good Clinical Practices,” and
“Drug Development Process.” An understanding
of Good Clinical Practice (GCP) regulations and the
clinical trials process, at least at the level that is
covered in “Drug Development Process.”
JACQUELINE MARDELL, B.A.
SANTA CLARA CLASSROOM WITH ONLINE MATERIALS
5 meetings: Tuesdays, 6–9 pm,
April 10–May 15 (1 no meeting TBA).
Fee: $580 ($58 discount for early enrollment).
To enroll, use Section Number 20787.(010)
ACCESS TO ONLINE MATERIALS
online materials indicates that classroom instruction
is supplemented with online materials or activities.
Students who enroll in these courses, and in those
which are entirely online, will receive logon information
within 24 hours. However, valid logon information
may not be active until the course’s start date.
Medical Device Design and Development
For course description, see page 11.
Molecular Diagnostics
For course description, see page 11.
Preparing for FDA Inspections and
Conducting Sponsor Audits
BUSAD.X484.1 (1.5 quarter units) CA BRN/LVN Credit–
Provider #CEP13114, 15.0 hours.
In the regulated medical industry, inspections by
government agencies are often a prerequisite for new
product marketing approvals. Knowing what to expect
and how to respond to clinical inspections is as critical
as conducting sound clinical research. This course helps
participants prepare for FDA inspections and conduct
sponsor audits. Topics include investigator and sponsor/
monitor inspections; how and when inspections occur;
FDA inspection procedures and practices; conducting
sponsor audits and inspections; interacting professionally
with inspectors; and responding effectively to inspectors’
observations.
Prerequisite(s): “Good Clinical Practices.”
FRANCES ANN MCKENNEY, M.S.
SANTA CLARA CLASSROOM
4 meetings: Fridays, 6–9 pm, May 4–June 1.
Fee: $580 ($58 discount for early enrollment).
To enroll, use Section Number 5168.(019)
Regulation of Drugs and Biologics
For course description, see page 17.
Toxicology Basics for Biotechnology
For course description, see page 11.
Also of Interest
Biology of Cancer
For course description, see page 10.
Viruses, Vaccines and Gene Therapy
For course description, see page 11.
Biosciences Clinical Trials / MEDIcal devices
Medical Devices
Medical Devices
Coming in Summer 2012
New Certificate Program
in Medical Devices
See ucsc-extension.edu/meddevices for details
Program Contact
Applied and Natural Sciences Department, (408) 861-3860,
or e-mail program@ucsc-extension.edu.
Program Overview
The Bay Area has the highest concentration of
medical device startup companies in the United States.
UCSC Extension has developed an array of cutting-edge
courses for professionals currently working in this
growing industry and for those interested in taking
their skills and career in a new direction.
Our courses will help you gain a solid foundation
in the principles underlying the design of medical devices,
and an understanding of the regulations governing the
manufacturing and marketing of diverse biomedical
products.
Electronic Records for
Regulated Environments: Cost-Effective
Approaches to Compliance
For course description, see page 18.
Intellectual Property Essentials
for the Life Science Industry
For course description, see page 11.
Medical Device Design and Development
For course description, see page 11.
Medical Devices: Regulatory Strategies
and Marketing Pathways
For course description, see page 12.
Molecular Diagnostics
For course description, see page 11.
Post-Market Regulatory
Obligations for Medical Devices
For course description, see page 18.
Regulation of Medical Devices
and Diagnostics
For course description, see page 17.
Regulatory Compliance
for Medical Devices
For course description, see page 17.
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