SPRING - UCSC Extension Silicon Valley

Biosciences REGULATORY AFFAIRS
Required Courses
Drug Development Process
For course description, see page 9.
Regulation of Medical Devices
and Diagnostics
NATSC.X400.017 (3.0 quarter units)
Starting with the definition of medical devices, an
overview of the medical device industry, and the historical
roots of medical device regulation, the instructor lays
a foundation for understanding the unique aspects of
medical devices and the pathways through which various
classes of products are moved into the U.S. marketplace.
Students gain in-depth exposure to key routes to market,
including 510(k) premarket notification and premarket
approval applications (PMA). Students gain insight into
the rationale and strategies for using each of these paths,
as well as the clinical testing of devices, and the investigational
device exemption (IDE) application and process.
NANCY ISACC, J.D., M.S.
ANNA LONGWELL, J.D., M.B.A., M.S.
SANTA CLARA CLASSROOM WITH ONLINE MATERIALS
10 meetings: Wednesdays, 6–9 pm,
March 28–June 20 (3 no meetings TBA).
Fee: $825 ($82.50 discount for early enrollment).
To enroll, use Section Number 19071.(013)
Regulation of Drugs and Biologics
NATSC.X400.009 (3.0 quarter units)
Complex regulations govern the development, manufacture,
and commercialization of biomedical products.
This course helps participants understand the regulatory
requirements, both U.S. and international, for patented
and generic pharmaceuticals, over-the-counter drugs,
and biological products. Students gain knowledge and
insight into the regulatory agencies and their roles and
responsibilities; regulatory applications and pathways;
postmarketing requirements; the impact of regulatory
differences between the U.S. and other countries; and
how regulatory approval processes affect corporate
strategy.
Prerequisite(s): Completion of, or concurrent enrollment
in “Drug Development Process” or equivalent experience.
SHELDON MULLINS, M.B.A.
SANTA CLARA CLASSROOM
10 meetings: Mondays, 6–9 pm,
April 9–June 25 (1 no meeting TBA).
Fee: $825 ($82.50 discount for early enrollment).
To enroll, use Section Number 19007.(014)
Regulatory Submissions:
Drugs and Biologics
NATSC.X400.014 (2.0 quarter units)
Submissions to a regulatory agency such as the FDA
involve more than just writing. They also encompass
strategy, editing, publishing and systematic tracking
of key information. Through lectures, case studies and
hands-on exercises, new and experienced regulatory professionals
learn how to work with regulations, guidance
documents and style guides to produce submissions
that comply with the requirements and are clear to the
reviewers.
This practical course uses approved drug labels and
summary basis of approvals to help students acquire the
knowledge and insight needed to understand and begin
to construct core U.S. drug and biologics submissions,
including premarketing (IND), marketing (NDA/CTD) and
postmarketing documents. Students also gain experience
with tools that help manage timelines and sections
needed from contributors.
Prerequisite(s): “Drug Development Process,” and
“Regulation of Drugs and Biologics.”
MEREDITH BROWN-TUTTLE, RAC.
SANTA CLARA CLASSROOM
8 meetings: Tuesdays, 6–9 pm,
April 10–June 26 (4 no meetings TBA).
Fee: $860 ($86 discount for early enrollment).
To enroll, use Section Number 19067.(012)
Regulatory Compliance
for Medical Devices
NATSC.X400.012 (2.5 quarter units)
Lectures, interactive discussions and case studies provide
in-depth exposure to the fundamental concepts and
major issues central to regulatory compliance in the
medical device sector. Emphasis is placed on using
the principles in the medical device quality system
(QS) regulation and ISO 13485 as tools to take a
process-oriented, risk-based approach to compliance,
while achieving strategic business objectives in today’s
dynamic regulatory environment. Students learn about
key quality system regulation processes and how to
recognize noncompliance. The instructor provides insight
into implementing an effective CAPA system and using
it as an improvement tool. Current industry trends, FDA
initiatives and best practices when interacting with
regulatory agencies are also discussed.
KIRAN GULATI, M.B.A., RAB-LA.
SANTA CLARA CLASSROOM
7 meetings: Wednesdays, 6–9:30 pm,
April 4–May 23 (1 no meeting TBA).
Fee: $800 ($80 discount for early enrollment).
To enroll, use Section Number 19029.(013)
RA Professional’s Toolbox
NATSC.X400.025 (1.5 quarter units)
This seminar-format course addresses important
competencies for RA professionals, including negotiation
and communication strategies, effective collaboration
techniques, project management, and approaches to
educating and motivating senior management and
staff about compliance. Through discussions, real-world
examples and case studies, senior regulatory professionals
help students learn about regulatory strategy, how to
work in the regulatory “gray zones,” and the important
legal and ethical responsibilities of regulatory affairs
personnel. This course should be taken toward the end
of the Regulatory Affairs Certificate Program curriculum.
LAURENCE WALLMAN, M.A., RAC (US, EU, CAN).
SANTA CLARA CLASSROOM WITH ONLINE MATERIALS
5 meetings: Thursdays, 6–9 pm,
May 17–June 28 (2 no meetings TBA).
Fee: $700 ($70 discount for early enrollment).
To enroll, use Section Number 19317.(010)
Regulatory Affairs
Advisory Board
Eric Anderson, Supervisory Investigator,
Food and Drug Administration
Meredith Brown-Tuttle, RAC, Consultant,
Regulatory Affairs
Jonathan Harris, Regulatory Affairs, Genentech
David Hoffmeister, Esq., Partner, Life Sciences
Practice, Wilson Sonsini Goodrich & Rosati
Anna M. Longwell, Esq., President,
Anna Longwell, PC
Jane Moffitt, J.D., LL.M., RAC, Director,
West Coast Operations, SciLucent
Kathy Nusser, CQA, RAC, Corporate Regulatory
Affairs Manager, Varian Medical Systems, Inc.
Virginia Perry, RAC, CQE, Partner, Regulatory
Affairs/Medical Devices, Perry-D’Amico &
Associates
Michelle Roeding, RAC, Section Manager,
Regulatory Affairs, Abbott Diagnostics Division—
Santa Clara
Robert I. Roth, M.D., Ph.D., Medical Director,
The Weinberg Group Inc.
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.
Course Readers, Textbooks
and Other Instructional Resources
Students are responsible for obtaining the required
instructional materials for all courses. A variety of
media are used. Please review the section details
at the bottom of the course description pages on
our Web site.
Instructors may specify any of the following:
• Printed course readers from our on-demand service
provider, Content Management Corporation (CMC)
• Electronic course materials from our online
learning platform, UCSC Extension Online
• Textbooks (required and recommended). See pages
5 and 94 and visit ucsc-extension.edu/bookstore.
• Other materials distributed via e-mail either by the
Academic Department or the instructor
Students should acquire or access their materials
prior to the first class meeting. For full instructions,
go to ucsc-extension.edu/course-materials.
Copyright © 2012 The Regents of the University of California. All Rights Reserved. 17