Regulatory Affairs

bioscience
yo u r U C i n S i l i c o n Va l l e y
Regulatory Affairs
Regulatory affairs professionals play critical roles in ensuring compliance with the laws and regulations guiding the
development and commercialization of healthcare products.
UCSC Silicon Valley Extension offers the Bay Area’s only
comprehensive classroom-based certificate program in
Regulatory Affairs, taught by expert instructors working in
the device, diagnostic, pharmaceutical and biologic sectors.
Established and aspiring professionals are grounded in the
ethical, management and professional competencies needed
to be effective in regulatory roles while learning how to
apply new techniques and methods in the real world.
ucsc-extension.edu/
regaffairs
Regulatory Affairs Certificate
Required Courses (six)
Certificate Requirements
To obtain the Certificate in Regulatory Affairs,
you must complete the six required courses and
5 units of elective courses, for a minimum total
of 19 units. For GPA requirements and program
time limits, see ucsc-extension.edu/regaffairs.
Program Prerequisites
Given the scientific foundations of the bioscience
industry and the importance of effective communication to the regulatory role, students who come to
the program with a basic understanding of the life
sciences and strong written and oral communication
skills will gain the most from this program.
Required Courses
Curriculum
UnitsCourse
Drug Development Process.......................... 2.0.........6559
Regulation of Medical Devices
and Diagnostics........................................... 3.0.......19071
Regulation of Drugs and Biologics............... 3.0.......19007
Interacting with the FDA.............................. 1.5.......19318
One of the following
Regulatory Submissions:
Drugs and Biologics OR......................... 2.0.......19067
Regulatory Submissions:
Devices and Diagnostics......................... 2.5.......19315
One of the following
Good Manufacturing Practices OR......... 3.0.........6328
Medical Devices Quality Systems............ 2.5.......30087
Drug Development Process
The development of new drugs is a complex,
lengthy, and expensive process. This course examines this process—from discovery to market and
beyond—and explores what makes the biopharmaceutical industry unique. Infused with real-world
examples, lectures address drug discovery;
preclinical characterization of new drug entities; the
phases and purposes of pharmacological and clinical
development; regulatory filings, compliance and
oversight; FDA jurisdiction; and strategic issues in
drug development. The course provides an important
foundation in drug development for professionals
who work in, or are considering a move to, the
biopharmaceutical industry.
Course 6559
Recommended Course Sequence
We recommend that students begin the
program with “Medical Device Quality Systems”
or “Good Manufacturing Practices,” followed by
“Drug Development Process” or “Regulation
of Medical Devices and Diagnostics.”
Applying for a Certificate
We encourage you to establish candidacy
in a certificate program early in your studies.
This ensures that curriculum changes subsequent to
receipt of your application will not affect your course
requirements. Candidates will be notified of updates
or special opportunities related to their program.
Certificate applications can be submitted online
at ucsc-extension.edu.
Courses may be taken individually or
as part of the certificate program.
Elective Courses (5 units required)
UnitsCourse
Design Control for Medical Devices............. 2.0.......21973
Drug Quality Fundamentals......................... 1.5.......23400
Global Medical Device Submissions
and Strategy................................................ 1.5.......20343
Good Clinical Practices................................ 3.0.........0458
Intellectual Property Essentials
for the Life Science Industry......................... 1.0.........1942
Medical Device Marketing .......................... 3.0.......30119
Preparing for FDA Inspections and
Conducting Sponsor Audits.......................... 1.5.........5168
Regulatory Intelligence................................ 1.0.......20341
Risk Management for
Regulated Industries.................................... 3.0.......22631
What’s the origin story of a medical device? This
course defines medical devices, introduces the
medical device industry and the historical roots of
device regulation. You’ll learn about key routes to
market, including 510(k) premarket notification and
premarket approval applications (PMA). You’ll be
exposed to the rationale and strategies for these
paths, as well as post-market surveillance tools employed by FDA, uses of clinical data for pre-market
and reimbursement purposes, and the investigational device exemption (IDE) application process. The
course covers international laws and regulations in
relation to U.S. counterparts.
Validating Software for Medical Devices
and Emerging Technologies......................... 2.0.......30379
Value-Added Quality Audits......................... 1.5.......19073
Regulation of Drugs and Biologics
Recommended
Data Privacy and Security for
Healthcare and Biosciences......................... 1.5.......30120
Enrollment Information
Visit ucsc-extension.edu/biosciences
for the most up-to-date information about
all our bioscience courses and programs,
including schedules and textbook
requirements.
Enroll online at ucsc-extension.edu.
Regulation of Medical Devices
and Diagnostics
Also of Interest
Clinical Trials Essentials:
An Intensive Course.............................. 3.5 ceus.........5433
Note: Any one course from UCSC Extension’s
Clinical Trials Design and Management or Medical Devices
Certificate Programs may be applied toward the elective
unit requirement for the Regulatory Affairs Certificate.
Copyright © 2015 The Regents of the University of California. All rights reserved.
Course 19071
Complex regulations govern the development,
manufacture, and commercialization of biomedical
products. This course will help you understand the
regulatory requirements, both U.S. and international,
for patented and generic pharmaceuticals, over-the
counter drugs, and biological products. You’ll 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.
Course 19007
Info
Clinical Trials, Regulatory Affairs, and Medical Devices Info Session
Are you interested in learning about the Clinical Trials, Regulatory Affairs, and Medical Device certificate programs, and about careers in these fields?
Session
This special information session provides an opportunity to meet instructors and other students, learn about program prerequisites, program philosophy, course content and program requirements, and gain insights into careers in clinical research, regulatory affairs, and medical devices.
Course 16650
To learn more, visit ucsc-extension.edu/events.
Interacting with the FDA
Elective Courses
Regulatory affairs professionals interact with the
U.S. Food and Drug Administration (FDA) throughout a biomedical product’s life cycle. Lectures, case
studies and roleplaying explore the interactions that
industry has with the FDA, including inspections and
key meetings. You’ll learn how to prepare for these
important events. The course highlights the FDA’s
structure, mission, jurisdiction and roles, reviews
agency centers and field offices, and examines societal, political, industrial and biomedical drivers that
impact policies, priorities, and the U.S. regulatory
environment. This course benefits regulatory professionals and anyone who interfaces with the FDA.
Course 19318
One of the following:
One of the following:
Design Control for Medical Devices
Good Manufacturing Practices
Familiarity with the Good Manufacturing Practices (GMP) regulations is necessary for employees
engaged in the manufacture, regulation, quality
assurance, and control of drugs and biologics.
Through lectures, discussions and case studies, you’ll
gain an understanding of the FDA GMP and Good
Laboratory Practice (GLP) regulations. While primarily aimed at the manufacturing, quality control and
quality assurance worker, the course is also useful
for regulatory affairs and clinical research professionals, as well as anyone who wants to understand
which regulatory controls apply to the manufacture
of drugs and biopharmaceuticals for human use.
Course 6328
This course uses approved drug labels and summary basis of approvals to help you acquire the
knowledge and insight needed to understand and
construct core U.S. drug and biologics submissions,
including premarketing (IND), marketing (NDA/CTD)
and postmarketing documents. 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. You’ll
also gain experience with tools that help manage
timelines and sections needed from contributors.
Course 19067
Medical Device Quality Systems
This course emphasizes using the principles of the
medical device quality system (QS) regulations and
ISO 13485 as tools to take a process-oriented,
risk-based approach to compliance, while achieving
strategic business objectives in today’s regulatory
environment. You’ll learn about key processes in the
quality system medical device regulation (21 CFR
820 and ISO 13485), while addressing noncompliance challenges. The course covers implementation
of an effective CAPA system and using it as an
improvement tool, as well as industry trends, FDA
initiatives and best practices for interacting with
regulatory agencies.
This introductory course introduces key drug quality
concepts and standards for the pharmaceutical and
biotechnology industries. Interactive lectures explore
quality system and control process best practices
in clinical development, drug manufacturing and for
commercial products. You’ll learn the roles and responsibilities of quality assurance (QA) and quality control
(QC) in ensuring the safety, efficacy and quality of drug
products. You’ll contrast specific quality attributes of
large-molecule recombinant biological products with
those of small molecule drugs. The course surveys
the analytical chemistry methodologies used to
assess and control physicochemical properties.
Course 30087
OR
Course 19315
Course 23400
Global Medical Device
Submissions and Strategy
Regulatory Submissions: Devices
and Diagnostics
Designed for individuals who already have a strong
foundation in medical devices, this course provides
hands-on experience working with the regulations,
guidance documents, and style guides needed for
FDA approval. You will explore the content and
process of medical device submissions and gain
insight into timelines, important strategic considerations, and business impacts. The course requires
substantial out-of-class work on a submission
project, where you will be crafting a 510(k). Please
plan your schedule accordingly.
Course 21973
Drug Quality Fundamentals:
Quality Control of Small Molecule
Drugs and Biologics
OR
Regulatory Submissions:
Drugs and Biologics
The successful development of medical devices
requires that the design be controlled to ensure product
safety and that the device can fulfill its intended use.
This course provides insight into the engineering value
of design control throughout the product lifecycle
as it pertains to product quality. You’ll learn the nine
design control elements to clarify design objectives,
test products, and satisfy customer requirements,
thereby shortening the path to product and business
success. The course highlights the practical implementation of the design history file, reviews and records,
transfer planning, configuration management,
requirements engineering and project planning.
Keep your RAC certification current
RAPS Credit: Many of the required
and elective courses in UCSC Extension’s
Regulatory Affairs Certificate Program
qualify for points toward recertification
for RAC.
See the Regulatory Affairs Profes­sionals
Society website at www.raps.org.
The international nature of the medical device industry
presents opportunities and challenges for medical
device companies and regulatory affairs professionals.
Through interactive lectures and facilitated group projects, you’ll gain insight into the international medical
device requirements and regulations for global markets,
specifically in the EU, Canada, Japan, and China. This
course compares regulatory and process similarities
and differences between countries and underscores
their impact on global regulatory and business strategies. The course benefits regulatory affairs professionals
interested in helping their organizations understand the
barriers to entry into the global medical device market.
Course 20343
Courses continue on reverse…
Good Clinical Practices
Clinical research is governed by a set of regulatory
requirements, industry standards and recommendations. Interpreting and implementing these “best
practice” standards presents a challenge for all
the stakeholders involved in human research.
This course explores the framework and principles
of Good Clinical Practice (GCP) as it relates to the
roles and responsibilities of various stakeholders like
the FDA, Investigator, Sponsor, IRB and the study
subject. Through lectures, homework, quizzes and
the final exam, you’ll gain knowledge of regulations
(federal, state and local) and learn to apply the
principles of GCP.
Course 0458
Intellectual Property Essentials
for the Life Sciences, High-Tech, Software, and Other Technology Areas
This course demystifies key intellectual property
principles and applications using lectures, case
studies and exercises. You’ll learn the basic principles
of intellectual property rights and their strategic
implications in securing funding, establishing barriers
to competitor entry, achieving freedom to operate,
technology transfer, federally funded research and
strategic alliances. In addition to patents, the course
addresses other forms of intellectual property,
including trademarks, copyrights, trade secrets
and contractual agreements. This course benefits
professionals who need to understand and manage
one of their company’s most valuable assets.
Course 1942
Medical Device Marketing
This course discusses how to market medical devices
in a regulated environment. You’ll learn to decode
FDA promotional compliance requirements, develop
claims needed for promotion during the product
development process, and understand how marketing
can commercialize medical devices. The course reviews
case studies and shares best industry practices to see
how new digital media affects promotion choices,
approaches to international marketing, and medical
device distribution. By the end of the course, you’ll
understand how to develop successful marketing
campaigns to grow, share, or energize an aging
brand, as well as to launch novel therapies.
Course 30119
Preparing for FDA Inspections
and Conducting Sponsor Audits
Value-Added Quality Audits
In the regulated pharmaceutical and biotech
medical device industries, 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
will help you 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.
Course 5168
Regulatory Intelligence
This course examines the fundamentals of regulatory
intelligence, including how it is conducted and how
it can be used to inform nonclinical, clinical, manufacturing, and regulatory decision-making throughout
the development program for a biomedical product.
The instructor takes a practical look at monitoring
the regulatory landscape. Through discussion and
hands-on class exercises, the instructor addresses
available information sources and provides insight
into how to collect, analyze and present regulatory
intelligence. This lays the groundwork for using
regulatory intelligence in developing global
regulatory strategy, either professionally or
in subsequent course work.
Course 20341
Risk Management for
Regulated Industries
This course discusses how risk management
is applied in the medical device, biotechnology,
pharmaceutical and in vitro diagnostic (IVD)
industries. Lectures and workshops delve into risk
management concepts and tools, including hazard
analysis, fault tree analysis, failure modes and
effects analysis (FMEA), Hazard Analysis and Critical
Control Point (HACCP), mitigation application,
regulatory requirements, and the creation of risk
management reports and files. By the end of the
course, you’ll be able to conduct risk management
for a variety of products, processes and services
within the biomedical industries and beyond.
Biotechnology
Clinical Trials Design and Management
Medical Devices
Regulatory Affairs
See ucsc-extension.edu/biosciences
for more information.
Course 19073
Also Recommended
Data Privacy and Security for
Healthcare and Biosciences
Many healthcare and bioscience companies utilize
Protected Health Information (PHI) or Personally
Identifiable Information (PII) to develop products
or to perform data analysis on their customer’s
healthcare related data. This course examines the
important data privacy and security issues that
govern these industries. Topics include relevant state,
national and international data privacy and security
regulations, medical device security and privacy,
FTC requirements, HIPAA training and risk analysis
requirements. You’ll examine issues relevant to your
industry and address these concerns by developing
a plan of action toward compliance with relevant
regulations and requirements.
Course 30120
Course descriptions and schedules can be found
at ucsc-extension.edu/regaffairs.
Course 22631
Validating Software for Medical Devices
and Emerging Technologies
Explore UCSC Extension’s
Bioscience Programs
By auditing to domestic and international quality
system regulations, biomedical corporations can
improve the effectiveness of their internal systems
and those of their suppliers and corporate partners.
This hands-on course introduces fundamental auditing principles and techniques, including planning,
conducting, analyzing, and communicating audit
results in terms that are meaningful to senior
managers. Through understanding the psychology
of audits and practice in questioning techniques,
you’ll learn to take their organization’s quality
audit program to another level.
Because an increasing number of medical devices
today run on software, there is a high demand for
quality assurance and regulatory affairs professionals
who can address the validation, documentation,
compliance and submission requirements unique
to software-controlled devices. This course covers the
software validation requirements of Class III medical
device software, mobile medical apps, medical device
data systems, manufacturing software, automated
test software, processes software, quality system
software and spreadsheets. Discussions cover the
FDA, EU and global perspectives on medical device
software validation and its related regulations,
guidance documents, and standards.
Earn Two Certificates:
Learn More for Less
Students pursuing the
Regulatory Affairs plus
Biotech­nology or Clinical
Trials Design and Management certificates
need a minimum of 32 units, including
all required courses and elective units for
both programs. Please note that in order to
complete two certificate programs with the
minimum number of units, students must
select some electives that are common to both
programs. Contact us at extensionprogram@
ucsc.edu or call (408) 861-3860 if you need
more information or would like assistance
creating a study plan.
Course 30379
Not printed or mailed at state expense. 611791-1502-2092 (5/15/15)