Quality Assurance/Regulatory Affairs
Not open to students who have taken the former PHARMACEUTICS 650.
Special topics in QA/RA (described in further detail in the schedule of classes).
5401. Fundamentals of
Pharmacology and Pharmacokinetics (3
Not open to students who have taken the former PHARMACEUTICS 400 or those in the Non-Thesis M.S. program who have taken PHARMACEUTICS 5401.
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.
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.
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.
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.
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. Note: This course is required for the M.S. in QA/RA, the Drug Development Certificate, and the Certificate in Clinical Trial Management.
Not open to students who have taken the former PHARMACEUTICS 489.
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.
5471. Biotechnology: Bioprocess Basics (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 481 or those in the Non-Thesis M.S. program who have taken PHARMACEUTICS 475 or PHARMACEUTICS 5471.
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).
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.
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.
5474. Process Validation (3
Not open to students who have taken the former PHARMACEUTICS 484.
Prerequisite: B.S. in Pharmacy, Biology, Chemistry, or Engineering and strong science background with familiarity in Biology, Chemistry, and Physics. Students should also have a basic understanding of pharmaceutical manufacturing processes.
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.
5476. Good Laboratory
Practices (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 486.
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. Note: This course fulfills the GXP requirement for QA/RA M.S. students and for the Drug Development Certificate.
This course provides an introduction to cGMP (current good manufacturing practices). Regulations for drugs under the Food, Drug and Cosmetic Act (21 CFR 210 and 211) and their implication for personnel, buildings, equipment, and records will be thoroughly reviewed and studied. It includes a study of pertinent legal decisions and regulatory actions based on non-compliance. Note: This course fulfills the GXP requirement for QA/RA MS students and for the Drug Development Certificate. Students with extensive manufacturing experience in GMPs may petition the School to allow them to replace the basic GMP class with Advanced GMPs. To do so, students must have at least five years of GMP experience and submit a resume to the QA/RA Office for final approval.
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.
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.
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 NADAs. 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.
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.
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.
Not open to students who have taken the former PHARMACEUTICS 494.
Prerequisite: PHARMACEUTICS 486, PHARMACEUTICS 487, or PHARMACEUTICS 536 (a Good Practices course).
This course covers topics in quality assurance principles, audit techniques, audit types, audit presentation and reports, auditing procedures for GMPs, GCPs, and GLPs. Note: This course is required for the M.S. in QA/RA; however, students interested in RA may substitute IND/NDA Submissions.
5495. IND/NDA Submissions (3
Not open to students who have taken the former PHARMACEUTICS 495.
Prerequisite: PHARMACEUTICS 5459 or PHARMACEUTICS 5592.
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. Note: This course is required for the M.S. in QA/RA: however, students interested in QA may substitute Quality Audit.
5496. Regulation of Medical
Devices: Compliance (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 496.
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.
5497. Statistics for
Clinical Trials (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 497.
Assuming no previous courses in statistics, this introductory course reviews topics of interest in statistical evaluation of clinical trials.
5498. Computer Validation (3
Not open to students who have taken the former PHARMACEUTICS 498.
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).
5499. Drug Dosage Forms (3
Not open to students who have taken the former PHARMACEUTICS 499.
Prerequisite: Strong science background.
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.
Not open to students who have taken the former PHARMACEUTICS 501.
A study of the theory and practice in the development of parenteral products; dosage form design, formulation, solubility/physical pharmacy, excipients, assays, stability, physiochemical properties of biomolecules, delivery systems for controlled/sustained release and manufacturing methods.
This course provides an overview of medical device submissions. The course begins with a review of laws specific to medical devices such as the requirement for pre-market submissions. Specific topics include device classification, investigational device exemption (IDE) applications, pre-market notification submissions [510(k)s], pre-market approval applications (PMAs), humanitarian device exemptions (HDEs), product development protocols (PDPs), STED and an overview of Global Harmonization Task Force recommendations.
5505. Global Regulation
of Medical Devices (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 505.
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 students 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.
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.
Not open to students who have taken the former PHARMACEUTICS 511.
Prerequisite: PHARMACEUTICS 494 and PHARMACEUTICS 486, PHARMACEUTICS 487, or PHARMACEUTICS 536 (a Good Practices course) or permission of instructor.
This course, which is a continuation of PHARM 5494: Quality Audit, 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.
Concepts In Pharmaceutical Manufacturing (3
Not open to students who have taken the former PHARMACEUTICS 512.
This course addresses essential microbiology concepts of manufacturing and quality control that form the basis of Good Manufacturing Practices for both sterile and non-sterile pharmaceuticals. Emphasis is placed on a review of the following from a microbiological perspective: manufacturing technologies and techniques, building quality into processes, influence of raw material quality on finished product, the meaning of the qualification and validation studies conducted by drug firms, and key microbiological tests performed at in-process and finished product stages. The course stresses practical matters and includes case studies to prepare students for daily issues arising in industry.
5516. Cleaning Validation (3 s.h.)
This course will review the different aspects of a pharmaceutical cleaning validation program and the criteria for each. The course will go from protocol to final report with emphasis on the regulatory risks and consequences. FDA and other regulatory agency observations will be highlighted to reinforce class material.
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.
5534. Regulatory Aspects
of Biomedical/Technical Communication (3
Not open to students who have taken the former PHARMACEUTICS 534.
Prerequisite: PHARMACEUTICS 5459 and PHARMACEUTICS 5592 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.
5535. Advanced Topics
in Labeling Development (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 535.
Prerequisite: PHARMACEUTICS 5533 and PHARMACEUTICS 5592 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.
5536. Good Clinical Practices (3
Not open to students who have taken the former PHARMACEUTICS 536.
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. Note: This course fulfills the GXP requirement for QA/RA M.S. students and for the Drug Development Certificate. It is required for the Certificate in Clinical Trial Management.
5537. Clinical Trial
Not open to students who have taken the former PHARMACEUTICS 537.
Prerequisite: PHARMACEUTICS 5536 or permission of instructor.
This course is designed to help the clinical research department member and those familiar with the industry working in related fields become more effective members of the clinical research team, whether at a company or an investigator's office. This course covers the day-to-day operations of a clinical trial, from site and investigator selection through monitoring and data retrieval. It covers key topics such as budgeting, protocol preparation, site and investigator selection, monitoring, document and file creation and maintenance, and the participation of key members of the principal investigator's team. Note: This course is required for the Certificate in Clinical Trial Management.
5538. Clinical Safety
and Risk Management (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 538.
Prerequisite: PHARMACEUTICS 5459.
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. Beginning with an historical overview of IND and international safety requirements, it examines the processes and systems in place to support compliance and the strategic documentation required for applications. It also looks at the role of risk management and epidemiological methods used to identify the signals used to quantify, assess, and communicate adverse drug reactions (ADR). Topics include clinical trial policy, the roles of the investigator, patient, and IRBs, privacy issues, informed consent, DSMB, and other related matters. Note: This course may be substituted in place of Clinical Data Management in the Certificate in Clinical Trial Management.
5539. Global Clinical Drug Development (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 539.
Prerequisite: Two of the following courses: PHARMACEUTICS 5459: Drug Development, PHARMACEUTICS 5536: Good Clinical Practices, PHARMACEUTICS 5591: Global Regulatory Affairs, or PHARMACEUTICS 5592: Food and Drug Law.
This course focuses on the specific regulatory requirements of clinical development in the European Union, Easter Europe, Latin America, Canada, India, China and Japan. It will review the efforts of the International Conference on Harmonization (ICH) to unify Good Clinical Practices (GCPs) in these global areas, exploring the differences between cultures, races, and societies and the impact of socialized medicine. Upon successful completion of this course, students will: gain an overview of multinational clinical drug development; gain a basic understanding of cultural differences towards GCPs in various regions of the world; understand key regulatory bodies and concepts governing clinical development in various global markets; and become familiar with the ICH and its legal requirements for global clinical development. Note: This course may be substituted in place of Clinical Trial Management in the CTM certificate.
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 (such as 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 on 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 required.
This course examines the broad scope of training requirements in the pharmaceutical industry, focusing on compliance issues with regulations governing US and other major world markets in the pre-clinical, clinical, manufacturing, and post-market arenas. After examining the specific regulations governing pharmaceutical industry training, students will learn to evaluate the components of successful industry training formats by acquiring a basic understanding of the statistical techniques used to evaluate its success. During the course, students will develop and implement a mock training program for a specific segment of the industry (GLP, GMP or GCP).
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.
Not open to students who have taken the former PHARMACEUTICS 546.
An integral part of almost all pharmaceutical dosage forms, excipients play an important role in drug development. This course discusses the function of excipients, providing an in-depth examination of their unique yet globally diverse regulatory requirements in major world markets. Excipient selection, assessment, and supplier qualifications will be discussed, as well as Adverse Events (AEs) related to excipient quality. This course stresses how global pharmaceutical excipient regulation is critical in developing formulations that have the potential for international approvals.
Safety Surveillance (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 571.
This course provides an in-depth understanding of post-marketing safety surveillance (PMSS) in the context of both American (FDA) and international (ICH-E2C) regulatory requirements. It begins with a historical overview of PMSS and then reviews the role of 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 are discussed.
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.
Not open to students who have taken the former PHARMACEUTICS 570.
Prerequisite: PHARMACEUTICS 5599 or PHARMACEUTICS 5602.
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.
5575. Regulatory Sciences:
Managing the Guidelines to Quality (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 580.
Prerequisite: Strong science background and permission of instructor.
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. Regulatory agencies are increasingly willing to engage in dialogue when filings are justified by data and clear scientific rationale presented.
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.
Prerequisite: PHARMACEUTICS 5459: Drug Development or PHARMACEUTICS 5592: Food and Drug Law. PHARMACEUTICS 5536: Good Clinical Practices is also recommended. Students who do not meet these prerequisites should fax their resume with their registration to seek special permission to take the course.
This course provides students with a basic understanding of the key regulations and laws that influence the development and management of a pharmacovigilance system, either in a manufacturer or health agency environments. The main emphasis will be on FDA, EU, and Japan and ICH, but discussions of emerging countries’ systems will also be included. In addition to pharmaceuticals, the course provides an overview of the related product vigilance areas, such as medical devices, over-the-counter products, and drug/device combinations. In addition to understanding the regulatory framework, additional instruction will include discussions of partnership agreements, pharmacovigilance aspects of due diligence, licensing and acquisitions, and product liability issues.
5589. Advanced Topics in Regulatory
Aspects of Biomedical/Technical Communication (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 589.
Prerequisite: PHARMACEUTICS 5459, PHARMACEUTICS 5534, PHARMACEUTICS 5592, 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.
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 United States. Future regulatory structures in the major world markets are explored.
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. Note: This course is required for the M.S. in QA/RA and for the Drug Development Certificate.
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.
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.
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.
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. Students may take PHARM 5599 and PHARM 5602 in either order.
5605. Advanced Topics in Food and Drug Law (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 605.
Prerequisite: PHARMACEUTICS 5592 or permission of instructor.
This course expands the regulatory concepts covered in PHARM 5592. Each semester the specific topics change.
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.
5612. Bioethics for Pharmaceutical Professionals (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 610.
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. Note: This course is required for the Certificate in Clinical Trial Management.
5615. Project Management for Pharmaceutical Professionals (3 s.h.)
Not open to students who have taken the former PHARMACEUTICS 615.
Prerequisite: At least four courses in the QA/RA program, including PHARMACEUTICS 5459: Drug Development and PHARMACEUTICS 5592: Food and Drug Law.
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.
Data management is the activity of collecting, reviewing, organizing, and analyzing data from clinical research studies. The data from clinical research studies are the crux of a regulatory submission for a new drug or biologic. There is no basis for a therapeutic claim without data. Thus the success of a submission depends on quality data management practices and strict adherence to regulatory requirements. This course teaches students how to go from collecting data for the first protocol to ultimate submission to a regulatory agency from data collection, management, and reporting perspectives. Note: This course is required for the Certificate in Clinical Trial Management.
Additional elective courses in Pharmaceutical Sciences can be found on the website: http://www.temple.edu/pharmacy_QARA/courses-electives.htm.