Courses
Quality Assurance/Regulatory Affairs
0400. Fundamentals of
Pharmacology and Pharmacokinetics (3
s.h.)
This introductory course to general pharmacology includes discussions
of the mechanisms of action of selected drug classes. It covers
pharmacokinetics, including clearance, bioavailability, compartment
models, extravascular dosing, nonlinear pharmacokinetics and
pharmacodynamics as they apply to the drug development process.
0451. Statistical Quality
Control (3 s.h.)
An introduction to statistical concepts, this course reviews
control charts for variables, probability theory, control charts
for attributes, and acceptance sampling systems. Class discussions
include application to quality control of pharmaceutical manufacturing.
0452. Acceptance Sampling (3
s.h.)
This course covers the statistical basis of acceptance sampling
plans and schemes and pharmacopoeial tests used in the pharmaceutical
industry in evaluating incoming raw materials, package components
and closures, in-process materials, and finished products.
Proper use of these plans and the degree of certainty they
provide for the accept/reject decision will be emphasized.
0459. Drug Development (3
s.h.)
This course studies the drug development process from discovery
through FDA marketing approval. It reviews the process of development
and the interrelationships linking the various disciplines,
introducing students to regulations governing the process,
including the interactions with FDA, ICH, and other regulatory
agencies.
0479. Advanced GMPs-Defining (3
s.h.)
Prerequisite: Successful completion of Pharmaceutics
487 or permission of instructor.
This course brings students from the basic GMP concepts presented
in Pharmaceutics 487 to a fuller understanding of the concepts
of current good manufacturing practices. Discussions include
how to evaluate FDA 483s and Warning Letters, the routine review
of periodicals, including the Pink Sheet, Gold Sheet, and other
GMP-oriented documents, and how to evaluate information provided
by the FDA. Recalls are discussed.
0480. Pharmacoeconomics (3
s.h.)
The economic methodologies used to evaluate the cost effectiveness
of drug therapy are reviewed. Cost effectiveness is examined
in terms of outcome assessment and quality of life measurements.
The course explores the dynamic environment of health care
and the process of drug product selection in managed care.
0481. Biotechnology:Bioprocess
Basics (3 s.h.)
This course covers the major steps of the biotechnology process:
preparation of media, fermentation, recovery, chromatography,
and related purification processes. Consideration is given
to their regulatory and control aspects. Included is an introduction
to basic biosciences (e.g., microbiology, biochemistry, and
genetic engineering).
0482. Pharmaceutical
Marketing (3 s.h.)
Prerequisite: Either Clinical Aspects of Pharmaceutical
Medicine I or II..
This course describes the marketing dynamics of the healthcare
industry and the ways in which pharmaceutical companies can
better meet the changing needs of patients and managed care.
Focusing on individual marketing techniques, it stresses the
development of multidisciplinary marketing teams. The product
attributes discussed in the selling process are efficacy, safety,
cost effectiveness, compliance, and treatment outcomes.
0483. Generic Drug Regulation
(ANDAs) (3 s.h.)
By examining specific case studies of Abbreviated New Drug
Applications (ANDAs) which document the bioequivalence of generics
to an original product, this course gives students an overview
of regulatory requirements for generics, introducing problems
unique to this segment of the industry.
0484. Process Validation (3
s.h.)
Since the concept of “validation” originally appeared in GMP
regulations, it has extended to every step in product manufacturing
from building the plant to the methods used for testing and
releasing its products. The course exposes students to all
aspects of validation. FDA Guides and Guidelines, as well as
the current emphasis on validation concerns by FDA (as identified
in 483 and Warning Letter observations), will be incorporated.
Students develop acceptable validation protocols and learn
what constitutes an acceptable validation report.
0486. Good Laboratory
Practices (3 s.h.)
This course explores the regulatory and quality assurance issues
pertinent to pre-clinical safety research. Research study design
and processes will be analyzed by pharmacologic and toxicologic
methods and for carcinogenicity and reproductive toxicology.
Some time is devoted to mutagenicity and pharmacokinetics,
discussed in the context of developing a safety profile and
determining the potential risk to humans in subsequent clinical
trials.
0487. Good Manufacturing
Practices (3 s.h.)
This course studies cGMP (current manufacturing practices)
regulations for drugs under the Food, Drug and Cosmetic Act
and their implication for personnel, buildings, equipment,
and records. It includes a study of pertinent legal decisions
and regulatory actions.
0488. High Purity Water
Systems (3 s.h.)
This course examines high purity water systems from the Quality
Function perspective, covering basic aspects of system design
and operation. Special attention is paid to unit operations,
sanitization procedures, and routine monitoring programs. Students
learn to plan validations and establish routine monitoring
programs to assess ongoing quality. Domestic (NFDWR/NSDWR)
requirements and international standards and regulatory expectations
are discussed.
0489. Pharmaceutical
Laboratory Quality Systems (3 s.h.)
The laboratory plays a key role in the manufacture and release
of pharmaceuticals. An effective QC lab assures the integrity
of the data generated to enable the release of raw materials,
in-process, and finished products and also meets production
schedules. In addition, production-related responsibilities
must meet with compliance standards. This course covers these
responsibilities in detail while providing insight on how to
meet internal and regulatory requirements for lab operations.
Why labs fail and what actions must be taken to prevent failure
are covered in depth.
0490. Pre-Approval Inspections (3
s.h.)
This course provides a detailed overview of Pre-Approval Inspections
and how to conduct audits of facilities based on the responsibilities
delineated in a pending drug application, including NDAs, ANDAs
and ANDAs. Emphasis is placed on reviewing the Pre-approval
audit process, Pre-Approval laboratory issues (including analytical
and microbiological), technology transfer, case studies involving
various dosage forms, and outsourcing issues. This course stresses
key areas for Pre-Approval inspection audits. Case studies
help prepare students for issues arising during a Pre-Approval
inspection. The history and evolution of the Pre-Approval program
are discussed.
0492. Sterile Products:
Parenterals (3 s.h.)
This course reviews the theory and practice involved in the
preparation of sterile, injectable products, covering formulation,
manufacturing, facility requirements, validation and regulatory
issues. Upon completion of the course, students will develop
an understanding of the routes of administration of injectable
drugs and the types of injections, current formulation methods,
aseptic manufacturing processes, requirements for sterile manufacturing
facilities, and validation, compliance and regulatory issues.
0493. Sterilization Processes:
Manufacturing (3 s.h.)
This course surveys sterilization processes used in the pharmaceutical,
medical device, in-vitro diagnostic, and biotech industries.
Current methods of sterilization are discussed, including thermal,
gaseous, radiation, filtration, and aseptic processing. Students
learn basic aspects of sterilization science as well as design,
review, and audit sterilization validations and processes according
to industry practices.
0494. Quality Audit (3
s.h.)
Prerequisite: A Good Practices Course (Pharm 486,
487, or 536)..
This course covers topics in quality assurance principles,
audit techniques, audit types, audit presentation and reports,
auditing procedures for GMPs, GCPs, and GLPs
0495. IND/NDA Submissions (3
s.h.)
This course covers the development of IND and NDA submissions
for FDA review. The major emphasis is directed toward developing
an understanding of the philosophies and requirements FDA imposes
on data submitted to support INDs and NDAs. It covers the process
of producing INDs and NDAs (managing the teams, producing the
submission, using electronic media) and emphasizes how to work
with FDA to gain approval of a submission. FDA meetings, advisory
panel hearings, appeals, strategies for review and approval
of NDAs, use of Orphan drug status, and the various avenues
for expedited review are discussed.
0496. Regulation of Medical
Devices: Compliance (3 s.h.)
This course examines the broad scope of the medical device
industry and its quality assurance practices, covering the
preclinical, clinical, manufacturing, postmarket reporting,
and device-tracking compliance regulations in the U.S. and
other major world markets.
0497. Statistics for
Clinical Trials (3 s.h.)
Assuming no previous courses in statistics, this introductory
course reviews topics of interest in statistical evaluation
of clinical trials.
0498. Computer Validation (3
s.h.)
This course focuses on the application of computer validation
concepts to computer systems operating within a pharmaceutical
research and development environment. It presents the specific
needs and responsibilities of the various regulatory requirements
and guidelines (both domestic and global).
0499. Drug Dosage Forms (3
s.h.)
Through an overview of drug dosage form design and manufacturing
technology, principles of pharmaceutical processing and pharmaceutical
dosage form design (including preformulation and biopharmaceutics)
are discussed, including dosage forms such as tablets, capsules,
modified dosage forms, semi-solid products, and transdermal
delivery systems.
0500. Regulation of Medical
Devices: Submissions (3 s.h.)
This course reviews and analyzes the submissions and regulatory
strategies for medical devices required by worldwide regulatory
agencies. Reviewing the history of global medical device regulation,
it will discuss classification systems and submission requirements
for low- and high-risk medical devices used in the U.S., Canada,
Europe, and other major markets. It proposes the formulation
of a strategic plan for worldwide regulatory submissions, minimizing
the time from development to entry in each major market.
0505. Global Regulation
of Medical Devices (3 s.h.)
This course provides an overview of international medical device
regulations. Beginning with a discussion of the similarity
of global requirements including both voluntary and mandatory
standards and directives and progressing to in-depth analyses
of market specific requirements, the course provides the student
with resources to meet the regulatory requirements for the
largest world markets. The Medical Device Directive, the In
Vitro Diagnostic Directive and the Active Implantable Medical
Device Directive will be discussed as well as initiatives by
the Global Harmonization Task Force related to the classification,
development and complaint handling for medical devices. As
part of this course, the student will learn the quality system
requirements of ISO13485, risk management according to ISO14971
and how to CE mark their product. Country-specific regulatory
requirements for Canada, EU, Australia and Japan are included.
0510. Environmental Law
and Regulation (EPA) (3 s.h.)
This course explores the regulatory arena of the agricultural
and chemical industries. Students gain a basic knowledge of
environmental laws and the key federal agencies (e.g., EPA,
NRC, USFWS) influencing the chemical industry. Building upon
QA/RA skills, students interpret and understand the development,
registration, and manufacturing of EPA-related products such
as pesticides. They acquire a deeper appreciation of the global
impact of pesticide regulation and examine registration requirements
for international quality assurance (e.g., EU/OECD, MJAFF).
Discussions of many well-publicized controversies such as Proposition
65 in California, Rachel Carson's Silent Spring, federal ground
water regulation, and the use of hormones in animal food are
included, in addition to a field trip.
0511. Advanced Audit
Workshop (3 s.h.)
Prerequisite: Pharm 494 and a Good Practices course
(486, 487, or 536) or permission of instructor..
A continuation of Pharmaceutics 494 (Quality Audit), this course
discusses the components of a quality system in greater depth
and detail, including control systems, procedures, and documentation.
Students design and audit a quality system; they also audit
and critique quality systems presented by the faculty member.
0512. Microbiological
Concepts In Pharmaceutical Manufacturing (3
s.h.)
Prerequisite: Pharm 592 and a Good Practices course
(486, 487 or 536)..
This course addresses microbiology concepts of manufacturing
and quality control forming the basis of GMPs for sterile and
non-sterile pharmaceuticals. Utilizing case studies, it reviews
manufacturing technologies and techniques, building quality
into processes, the influence of raw material quality on finished
products, qualification and validation studies conducted by
drug firms, and key microbiological tests performed at in-processs
and finished product stages.
0533. Requirements for
Product Labeling and Advertising (3
s.h.)
This course examines strategies for creating drug labeling
during new product development, for updating existing product
labeling, and for creating “harmonized” core data sheets for
products marketed globally. Students gain insight and awareness
of current trends in advertising and promotional regulation.
0534. Regulatory Aspects
of Biomedical/Technical Communication (3
s.h.)
Prerequisite: Pharm 459 and 592 or permission of instructor..
This course reviews regulatory requirements of biomedical/technical
writing in the pharmaceutical industry. Students research,
summarize, and organize typical scientific data. Issues of
content (relevancy, accuracy, balance, and currency), organization,
and style (e.g., American medical Association Manual of Style
and current FDA and ICH guidelines) are addressed. Writing
exercises include topics such as the Physician's Desk Reference,
developing product label package inserts, and summarizing studies
in pharmacokinetics, pharmacodynamics, efficacy and safety,
product development, and stability.
0535. Advanced Topics
in Labeling Development (d s.h.)
Prerequisite: Pharm 592 and 533 or permission of instructor..
This course reviews the regulatory and legal fundamentals of
labeling FDA-regulated products, specifically, prescription
pharmaceuticals, emphasizing the direct application of the
regulations to actual practice. It analyzes case studies and
current practices, providing an overview of legal, regulatory,
and marketing concepts affecting labeling. It discusses the
application of current knowledge and explores new trends in
the legal and regulatory framework surrounding the development
and implementation of drug labeling. As a class project, students
are assigned to drug development teams (Regulatory Affairs,
Marketing and Clinical) and provided with the known data of
their compounds. Teams determine what information is needed
to complete the draft labeling for NDA submission, and develop
a final label; they hold mock negotiations (internal and with
the Agency) and propose changes to labeling in response to
post-marketing surveillance.
0536. Good Clinical Practices (3
s.h.)
This course examines the federal regulatory requirements and
processes necessary to conduct valid drug trials on human volunteers.
Emphasis is placed on managing the clinical drug study and
auditing its processes and generated data. The course also
addresses ethical issues and volunteer informed consent.
0537. Clinical Trial
Management for Research Practitioners (3
s.h.)
Prerequisite: Pharmaceutics 536 or permission of instructor..
The study coordinator assisting the principal investigator
of a clinical trial has a critical role in its success. Exposes
research practitioners to a broad spectrum of clinical research
topics and provides an in-depth understanding of the pharmaceutical
industry. Examines the clinical research process from a regulatory
and procedural basis and research topics and provides an in-depth
understanding of the pharmaceutical industry. Examines the
clinical research process from a regulatory and procedural
basis and addresses project management, effective site management
techniques, monitoring, ethical considerations for the protection
of human subjects and the quality of data.
0538. Clinical Safety
and Risk Management (3 s.h.)
Prerequisite: Pharm 459..
This course provides students with an in-depth understanding
of what pre-marketing clinical safety and risk management (CSRM)
means in the context of both American (FDA) and international
(ICH-E2C) regulatory requirements. It covers the historical
overview of IND and international safety requirements, the
processes and systems in place to support compliance, strategic
documentation for applications, and the role of risk management,
and epidemiological methods to identify signals, quantify,
assess, and communicate adverse drug reactions (ADR). Clinical
trial policy issues, investigator, patient, IRB, DSMB, privacy,
informed consent, and other related matters are discussed.
0540. Pharmaceutical
Packaging: Technology and Regulation (3
s.h.)
This course focuses on the complexities of packaging for the
pharmaceutical industry, covering commonly used packaging systems
(bottle/blister packaging for Oral solids) as well as niche
applications like sterile/parenteral, inhalation and nasal
systems. In addition to the container/closure systems, some
of the packaging processing methods will be covered. A review
of the applicable regulatory environment and the submission
requirements for drug products will be included. The submission
needs will be covered, with a focus of the needs of the newly
implemented Common Technical Document (CTD). A visit to a manufacturing
facility of one of the industry's suppliers will be part of
the class.
0545. SUPAC (3
s.h.)
Prerequisite: Pharm 487 or 586 or permission
of instructor..
This course reviews SUPAC guidelines developed by CDER to maintain
product safety, efficacy, and quality while giving manufacturers
substantial regulatory relief and flexibility. A basic review
of formulation development of various dosage forms provides
a complete understanding of the guidelines and of regulatory
strategies for formulation development.
0570. Pharmacoepidemiology (3
s.h.)
Prerequisite: Suggested prerequisite: Pharm 599 or
602..
This course introduces students to principles of study design,
concepts of causal inference, and major types of epidemiological
studies. These principles are applied to the distribution and
determination of the effects (expected and unintended, beneficial
and adverse) of pharmaceuticals on human populations. Risk-benefit
analyses, cost-benefit assessments, regulatory issues, and
legal and public health concerns are discussed.
0571. Post-Marketing
Safety Surveillance (3 s.h.)
Post-Marketing Safety Surveillance (PMSS) in the context of
American (FDA) and global (ICH-E2C) regulatory requriements.
Historical overview of PMSS. Epidemiological methods in identifying
signals and quantifying, assessing, and preventing adverse
drug reactions (ADR). Medical/legal issues, benefits and limitations
of safety surveillance systems, labeling changes, the ability
to refute false signals, and social and ethical obligations
inherent in the conduct of PMSS.
0572. Vaccines: QA/RA
Issues (d s.h.)
Prerequisite: Suggested prerequisite: Pharm 459..
This course addresses the history, research and development,
manufacture, marketing, and medical impact of vaccines. Various
public policy, regulatory, ethical, and legal issues in this
area are discussed as they pertain to the U.S. and, to some
extent, international markets. Beginning with the eradication
of smallpox, this course covers the development of widely used
vaccines against once common diseases (e.g., polio, mumps,
varicella, etc.), to the development of vaccines against HIV,
anthrax , and certain types of cancer.
0580. Regulatory Sciences:
Managing the Guidelines to Quality (3
s.h.)
Prerequisite: Strong science background required; permission
of instructor required..
The International Conference on Harmonization (ICH) has revolutionized
the format and content of global regulatory filings with the
Common Technical Document (CTD) serving as the platform for
this format change. Module 3 of the CTD is also known as the
Quality Section and pertains to information related to Chemistry,
Manufacturing and Control. ICH Quality Guidelines significantly
influence the content of this Module. Recent FDA draft guidelines
have incorporated and expanded upon concepts described by the
ICH. As the term ‘guideline' implies, such documents should
not be generally viewed as regulations, but as ‘recommendations'
to consider when developing the body of scientific information
that ensures a thorough scientific understanding and control
of product attributes. Proper interpretation of the guidelines
based on sound scientific principles is essential to optimize
both the quality and quantity of information submitted to global
regulatory agencies. Consequently, review of various ICH and
FDA Quality guidelines will be supplemented by a discussion
of the basic scientific principles that may influence implementation.
This course is designed to focus exclusively on guidelines
associated with the development of small molecules from Phase
1 through Phase 4 and will not address issues related to biotechnology.
After completing this course students should understand the
basic expectations set forth in various ICH and FDA Quality
Guidelines. They should also realize that the guidelines are
subject to interpretation and not definitive regulations.
0586. Global CMC Issues & the
Regulatory Dossier (3 s.h.)
The course provides students with an in-depth knowledge of
the major chemistry, manufacturing. and controls (CMC) issues
facing the global pharmaceutical industry. Students learn the
practical and theoretical skills necessary to develop successful
CMC dossiers from the initial clinical application through
marketing and post-marketing support. The class emphasizes
long range CMC planning to combine technical and regulatory
knowledge with strategic thinking. The class is designed for
regulatory professionals, managers, and scientists with significant
responsibility for CMC dossiers
0589. Adv Topics in Regulatory
Aspects of Biomedical/Technical Communications (3
s.h.)
Prerequisite: Pharm 459, 592, 534 or permission of
instructor..
This course is an in-depth discussion of regulatory writing,
including responding to FDA or Regulatory Agency Inquiries
on Scientific Reports, methods and validation reports for submission,
IND Technical Summaries, overviews of NDA preparation (including
style/editing of NDA assembly), CMC section of an NDA, the
Investigator's Brochure (ICH Guidelines), the expert report
for the European Union applications, developing product label
package inserts and Physician's Desk Reference monographs.
0591. Global Drug Regulatory
Systems (3 s.h.)
This course provides a detailed analysis of the regulatory
processes for new drug approvals outside of North America.
Students gain experience in comparing the European and Japanese
registration trends with those of the US. Future regulatory
structures in the major world markets are explored.
0592. Food and Drug Law
I. (3 s.h.)
This course studies the governance of intra- and interstate
commerce in foods, drugs, cosmetics, and medical devices and
the effects of the Federal Food, Drug and Cosmetic Act upon
research, manufacture, marketing, and distribution of drugs.
0592. Regulation of Dietary
Supplements, Botanicals, and Nutraceuticals (3
s.h.)
The course focuses on legal issues surrounding the regulation
of dietary supplements, nutraceuticals, and botanicals. When
does a dietary supplement become a drug under the Federal Food,
Drug and Cosmetic Act? What are the legal requirements for
labeling? How are claims treated? These topics, along with
current issues related to the regulations of dietary supplement
are explored. The impact of the Dietary Supplement Health and
Education Act, the Federal Food, Drug and Cosmetic Act, the
FDA Modernization Act (FDAMA), and other relevant laws are
examined. The enforcement authority of other federal regulatory
agencies, that is, the FDA and the Federal Trade Commission,
is detailed.
0594. Regulation of Dietary
Supplements, Botanicals, and Nutraceuticals (3
s.h.)
The course focuses on legal issues surrounding the regulation
of dietary supplements, nutraceuticals, and botanicals. When
does a dietary supplement become a drug under the Federal Food,
Drug and Cosmetic Act? What are the legal requirements for
labeling? How are claims treated? These topics, along with
current issues related to the regulations of dietary supplement
are explored. The impact of the Dietary Supplement Health and
Education Act, the Federal Food, Drug and Cosmetic Act, the
FDA Modernization Act (FDAMA), and other relevant laws are
examined. The enforcement authority of other federal regulatory
agencies, that is, the FDA and the Federal Trade Commission,
is detailed.
0599. Clinical Aspects
of Pharmaceutical Medicine I. (3
s.h.)
This course offers students a basic understanding of the disease
processes most prevalent in Western culture. Students gain
an appreciation for the epidemiology and demographic patterns
of disease and their societal and economic impact. In addition,
students gain a basic understanding of the etiology and the
pathophysiology underlying the disease processes and the role
of pharmacologic intervention.
Note: Students may take Pharmaceutics 599 or 602 in either order.
0601. Industry Interactions
with FDA/Health Authorities (3 s.h.)
Presenting a global perspective by reviewing the drug approval
process in the European Union (EU), this course introduces
students to the importance of establishing liaisons with officials
with the U.S. FDA and other world health authorities. The rapport
developed with health authorities frequently lessens the time
it takes to get a new drug to market. How a firm presents its
data can contribute as much to the successful relationship
with health authorities as the quality of data presented. Areas
include: FDA organization, average workload analysis with FDA,
FDA review and drug approval process, national versus mutual
recognition versus centralized approval process in the EU,
user fees, company “personalities,” FDA/Industry meetings,
inspections, Advisory Committees, IND/NDA classification system,
FDA initiatives to speed drug approval including electronic
submissions, and notable internet regulatory addresses.
0602. Clinical Aspects
of Pharmaceutical Medicine II. (3
s.h.)
Students study key areas of clinical medicine and scientific
topics such as genetics, gastroenterology, obstetrics and gynecology,
medical ethics, hepatology, and emergency medicine. This course
includes new issues and updates in specialties such as cardiology
and oncology.
Note: Students may take Pharmaceutics 599 or 602 in either order.
0605. Food and Drug Law
II. (3 s.h.)
Prerequisite: Pharmaceutics 592 or permission of
instructor.
This course expands the regulatory concepts covered in Pharmaceutics
592, focusing more on current issues and topics.
0610. Bioethics for Pharmaceutical
Professionals (3 s.h.)
This course focuses on bioethical issues arising in the regulation
and conduct of research. It instills a basic understanding
of bioethics and the theories and principles underlying its
practices and application to research. It also discusses how
bioethical theories and principles provide the foundation for
many research regulations. Starting with a brief history of
research ethics and regulation, it explores past and present
ethical research controversies.
0611. Adv Topics: Regulation
of Advertising & Promotions (3
s.h.)
Prerequisite: Pharm 533.
This course reviews the regulatory and legal fundamentals of
advertising FDA-regulated products, including prescription
pharmaceuticals, OTCs, and biologicals. Discussions will include
how these regulations differ from those applicable to restricted
medical devices and food products.
0615. Project Management (3
s.h.)
Prerequisite: Pharm 459.
This course discusses the strategic positioning of drugs, specifically
focusing on domestic and international registration strategies.
It explores why a company seeks a particular indication in
labeling and how RA/QA professionals play a critical role in
understanding and developing regulatory intelligences. It covers
how project teams should be created, including the effective
clarification of roles and responsibilities, so regulatory
timeliness can be achieved. Workshops include an overview of
project planning tools, techniques and critical path management,
including negotiating registration strategies with the FDA
and foreign agencies.
0618. Clinical Data Management (3
s.h.)
Therapeutic claims cannot be made without data. Data management
is the activity of collecting, reviewing, organizing, and analyzing
data from clinical research studies, forming the crux of a
regulatory submission for a new drug or biologic. The success
of a submission depends on quality data management practices
and strict adherence to regulatory requirements. Teaches students
how to go from collecting data for the first protocol to the
ultimate submission to a regulatory agency from a data collection,
management, and reporting perspective.