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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.