5000. Special Topics – RAQA
Special topics in RAQA (described in further detail in the schedule of classes).

5401. Fundamentals of Pharmacology and Pharmacokinetics
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. 
Not open to students who have taken RAQA 400 or RAQA 405.

5408. Pharmacoeconomics
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.
Not open to students who have taken RAQA 480.

5451. Statistical Quality Control
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.
Not open to students who have taken RAQA 451.

5458. The Global Biopharmaceutical Industry
Prerequisite: Drug Development (5459)
What social and economic factors contributed to the development of innovator and generic pharmaceutical companies, and what are their current and future trends? This course introduces students to the basic structure of the pharmaceutical industry, examining the growth and relationships among various sectors, including the fully-integrated companies of big pharma, the generic and biotech industry, and specialty and service companies, such as CROs and CMOs. Social, political, demographic, economic, and technological influences will be examined not only in the US domestic market, but also across major world economies, including the differences between national health and single-payer systems. A segment of the course focuses on the impact of the Waxman-Hatch Act on drug price competition and patent term restoration.

5459. Drug Development
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. 
This course is required for the MS in RAQA, the Drug Development Certificate, the Certificate in Clinical Trial Management, the Certificate in Biosimilars and Generic Drugs, and the Basic Pharmaceutical Development Certificate.
Not open to students who have taken RAQA 459.

5468. Validation of FUE (Facilities, Utilities and Equipment)
Prerequisite: Good Manufacturing Practices (5477) or appropriate industry experience in GMPs.
The production of FDA regulated products (pharmaceutical, medical device, food, etc.) is highly dependent on both the initial qualification of facilities, utilities, and equipment (FUE) along with the ongoing efforts to maintain the qualified/validated state by meeting current user and regulatory needs. This course focuses on the key validation elements specific to qualifying and validating facilities, utilities, and equipment. In practice, validation of these items is also a prerequisite for other validation efforts including process, cleaning and test method. The class will examine the key concepts of FUE qualification/validation as well as the life-cycle through retirement of the FUE.

5469. Pharmaceutical Laboratory Quality Systems and Operations
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.
Not open to students who have taken RAQA 489.

5471. Biotechnology: Bioprocess Basics
Prerequisite: Undergraduate introductory Biochemistry and Chemistry courses.
This course empasizes regulatory and control aspects of biologics manufacturing as well as Quality by Design (QbD) principles. It provides students with a basic understanding of the major steps involved in the manufacture of biologics/biopharmaceuticlas, including preparation of media, fermentation, harvesting/recovery, purification and formulation. Included is a review of basic bioscience topics (e.g., microbiology, biochemistry, and molecular biology) with particular relevance to the study of bioprocessing techniques.
Not open to students who have taken RAQA 481. Also not open to Non-Thesis Pharmaceutical Sciences MS students who have taken Pharmaceutics 475 or 5471.

5472. Pharmaceutical Marketing
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.
Not open to students who have taken RAQA 482.

5473. Generic Drug Regulation (ANDAs)
Prerequisite: Drug Development (5459).
When marketing exclusivity or the patent for a drug product expires, or the courts rule that the patent is not valid, other manufacturers can gain approval to market and sell a similar product. The manufacturers of these generic forms may obtain FDA approval based on an Abbreviated New Drug Application (ANDA), which documents the bioequivalence of their product to the pioneer brand product. This course reviews specific case studies of generic drug product approvals using ANDA regulations and court decisions. It provides an understanding of the current regulatory environment for generic drugs and introduces students to the problems and situations that are unique to this industry. A review of generic product categories (authorized generics, generic biopharmaceuticals, generic vaccines) includes the different approaches used to develop generic products, explaining terms such as a Paragraph IV filing. After discussing the interaction between generic drug companies and the FDA, foreign market regulations for generic drugs will be studied, covering global generic markets in Europe, Asia, South America, and other selected jurisdictions. Post-marketing regulation and pharmacovigilance will also be included.
Not open to students who have taken RAQA 483.

5474. Process Validation
Prerequisites: BS in Pharmacy, Chemistry, Biology or Engineering and strong science background, including familiarity with chemistry, biology, 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.
Not open to students who have taken RAQA 484.

5476. Good Laboratory Practices
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.
This course fulfills the GxP requirement for RAQA MS students and for the Drug Development Certificate.
Not open to students who have taken RAQA 486.

5477. Good Manufacturing Practices
This course is an introduction to current Good Manufacturing Practices for pharmaceuticals and pharmaceutical products. Regulations 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. 
Notes: this course fulfills the GxP requirement for RAQA MS students and for the Drug Development Certificate.
Students with extensive manufacturing experience in cGMPs may petition the School to replace Good Manufacturing Practices with Advanced GMPs-Defining "c" (5479). To do so, students must have at least five years of GMP experience and submit a resume to the RAQA Office for final approval. 
Not open to students who have taken RAQA 487.

5478. High Purity Water Systems
Prerequisite: college-level chemistry course.
This course examines high purity water systems from a 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.
Not open to students who have taken RAQA 488.

5479. Advanced Good Manufacturing Practices – Defining “c”
Prerequisite: successful completion of Good Manufacturing Practices (5477) or permission of the instructor.
This course brings students from the basic GMP concepts presented in Good Manufacturing Practices (5477) 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.
Not open to students who have taken RAQA 479.

5491. Pre-Approval Inspections
Prerequisites: Drug Development (5459) and Good Manufacturing Practices (5477).
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.
Not open to students who have taken RAQA 490.

5492. Production of Sterile Products
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.
Not open to students who have taken RAQA 492.

5493. Sterilization Processes
A study of the theory and application of sterilization processes in the preparation of sterile pharmaceutical products. The course lectures will cover basic principles and current sterilization technology. The course will focus on moist heat sterilization using autoclaves which is the predominant sterilization method employed in the production of pharmaceuticals. A case study will be used in the course demonstrating the specification, installation, qualification and regulatory approval of a new autoclave facility. An overview of gas and radiation sterilization will be provided. Specific pharmaceutical product examples using radiation and gas sterilization will be reviewed in detail. 
Not open to students who have taken RAQA 493.

5494. Quality Audit
Prerequisite: A Good Practices course (5476 or 5477 or 5479 or 5536).
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 MS in RAQA; however, students interested in RA may substitute IND/NDA Submissions.
Not open to students who have taken RAQA 494.

5495. IND/NDA Submissions
Prerequisite: Drug Development (5459) or Food and Drug Law (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.
This course is required for the MS in RAQA: however, students may take Quality Audit as an alternate.
Not open to students who have taken RAQA 495.

5496. Regulation of Medical Devices: Compliance
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.
Not open to students who have taken RAQA 496.

5497. Statistics for Clinical Trials
Assuming no previous courses in statistics, this introductory course reviews topics of interest in statistical evaluation of clinical trials. 
Not open to students who have taken RAQA 497.

5498. Computerized System Validation
This course studies the regulatory history and background for computerized system validation (CSV). The current FDA and global CSV relevant regulations including the predicate rules will be discussed. The course will also address compliance with 21 CFR Part 11. The course will introduce students to software development methods and deliverables as they relate to CSV. A wide range of computerized systems typically employed in regulated environments will be examined and their unique challenges will be discussed. Students will have opportunity for hands on practice in the development of a key validation deliverables and will complete an assigned project. Software development experience is not needed, but a better than average understanding of technology and the systems used in Life Sciences is expected.
Not open to students who have taken RAQA 498.

5499. Drug Dosage Forms
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 RAQA 499.

5502. Regulation of Medical Devices: Submissions
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. 
Not open to students who have taken RAQA 500.

5503. Design Controls for Medical Devices and Combination Products 
This course focuses on design control requirements and practices in the medical device and combination products industry. Class discussions will include design control requirements as they apply to medical devices and combination products. Current regulations and practices will be discussed and utilized to provide students with experience in executing design control activities for a range of products.
Note: Counts as an elective in the Medical Device Certificate.

5505. Global Medical Device Regulation
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.
Not open to students who have taken RAQA 505.

5506. Environmental Law and Regulation (EPA)
The mission of the Environmental Protection AGency (EPA) is to protect human health and the environment.  This course provides an understanding of basic environmental laws and regulations and EPA's enforcement activities.  Students will learn how to find, analyze and apply the significant laws that EPA administers, including the Clean Water Act (CWA), the Clean Air Act (CAA), the Endangered Species Act (ESA), Federal Insecticie, Fungicide and Rodenticide Act (FIFRA), Occupational Safety and Heath Act (OSHA), Toxic Substances Control Act (TSCA) and others, and well as Environmental regulations (40CFR).
Not open to students who have taken RAQA 510.

5507. Regulation of Non-Prescription Healthcare Products (OTCs)
Prerequisite: Food and Drug Law (5592)
This course examines non-prescription healthcare products in the U.S., including their legal status (both past and present). Starting with discussions of how non-prescription healthcare products are classified, the course will focus on the Food and Drug Administration’s OTC Monograph system and the OTC Monograph User Fee (OMUFA). Students will learn how non-prescription labeling evolved (including discussions on Drug Facts Labeling) and examine cases where prescription products were switched to OTC, including the impact of FDA’s NSURE Initiative, a draft guidance that will facilitate Rx-to-OTC switches. A brief overview of Non-Prescription classifications outside the U.S. will also be included.

5508. Good Pharmacovigilance Operations
Prerequisite: Clinical Drug Safety and Pharmacovigilance (5538) OR Post Marketing Safety Surveillance (5471).
This course provides a solid foundation for understanding/managing the complexities of the lifecycle of an individual case safety report (ICSR). It reviews the process from receipt of the ICSR to reporting to regulatory authorities (both as an expedited ICSR and within a periodic safety update report). It compares U.S. and EU regulations and ICH guidances in this area. It also covers the requirements for a validated safety database to process ICSR and Quality Systems in a  pharmacovigilance (PV) department. The course discusses the management of a PV department and the business decisions required to manage the volume of cases received. Also discussed is the role of PV agreements and preparation for a PV inspection.

5509. Pediatric and Orphan Drug Regulations
This course introduces students to pediatric and orphan disease drug development, which includes defining these two populations, discussing where they overlap, and the historical and current challenges in developing therapeutic products for them.  Biopharmaceutical medications and aspects of medical device development for these populations will also be included.  Discussions focus on legislative changes and the importance of legislative advocacy during the past three decades for pediatric and orphan disease drug development, as well as incentives to make drug development in these areas profitable.  While the primary focus of the course will be on the United States and the FDA, the course will include similar activities in the European Medicine Agency (EMA) and other relevant regulatory agencies around the world.  Specific examples of successful pediatric and orphan drug development programs are included as well as guest lecturers presenting current issues and trends in these areas.

5511. Advanced Audit Workshop of Quality Systems
Prerequisite: Quality Audit (5494) and a Good Practices course (5477, 5479, 5486, or 5536) or permission of instructor.
A continuation of Quality Audit (5494), 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.
Not open to students who have taken RAQA 511.

5512. Microbiological Concepts in Pharmaceutical Manufacturing
This course addresses essential microbiology concepts and contamination control of manufacturing and quality control that form the basis of Good Manufacturing Practices (GMPs) for both sterile and non-sterile pharmaceuticals. Emphasis is placed on a review of the following from a microbiological perspective: basic microbiology and microbial awareness, cleanroom design and microbiology, cleaning and disinfection, aseptic techniques, microbial identification, objectionable microorganisms, environmental monitoring, importance of risk assessment, manufacturing technologies and techniques, building quality into processes and contamination control strategy, influcence of raw material quality on finished product, microbial deviation investigations 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. 
Not open to students who have taken RAQA 512.

5513. Active Pharmaceutical Ingredients
Prerequisite: Drug Development (5459)
This course provides a working background on Active Pharmaceutical Ingredients (APIs) used in pharmaceutical dosage forms with focus on the development, manufacture and global regulations that impact successful marketing approval of products. The primary focus is on small molecule synthetic APIs.

5514. Regulatory eSubmissions
Prerequisite: Drug Development (5459).
This course will explore the evolution of global regulatory submissions from the original paper format to the current electronic common technical document (eCTD) and non-eCTD electronic submissions (NeeS). This course will primarily focus on current regulations, tools, and specifications associated with electronic submissions and electronic requirements of included documentation.

5515. Biologics/Biosimilars: A Regulatory Overview
Prerequisites: Drug Development (5459). Science background required.
Since the first biopharmaceutical product approval in 1982 (recombinant human insulin), the biotechnology derived product market has been rapidly growing with introduction of a number of promising advances in medicine such as therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors. As with traditional drugs (small molecules), the regulatory framework for approval of a biotechnology derived product (biologics) is complicated. In addition, there has been much debate about the introduction of biosimilars using an abbreviated approval process. An overall biologics-based process map beginning with pre-clinical through the post-marketing stage will be discussed. Topics such as therapeutic proteins/peptides, gene therapy, stem cells, vaccines, interference RNAs, PK-PD, world-wide regulatory filings, pre-clinical IND-enabling studies, BLA/CTD filing, biosimilars/follow-on-biologics, selected case studies, immunogenicity, comparability studies, manufacturing challenges, clinical trials, market exclusivity, and related regulatory guidelines will be discussed.

5516. Cleaning Validation
This course will cover the origins and historical development of cleaning validation and the current movement to Science-based, Risk-based and Statistics-based programs (ASTM Standard E3106). The course will review the chemistry and physics of cleaning and the development of cleaning processes, the calculation of cleaning limits, analytical method development and validation (with particular emphasis on Total Organic Carbon analysis and Visual Inspection) and how Risk Assessments are applied to the cleaning processes and their validation. The evolving regulatory landscape on cleaning validation starting from the FDA to the ICH to the EMA and other regulatory agencies will be discussed.

5518. Regulatory Issues in Pharmacogenomics
Pharmacogenetics (PGt) is the study of genetic causes of variability in drug metabolism (pharmacokinetics) and responses to drugs, including adverse events (AEs) and desired pharmacological effects (pharmacodynamics). Variability can be attributed to variations in DNA, such as polymorphisms, or sequences that influence an enzyme or a receptor activity. Pharmacogenomics (PGx) is the science involving pharmacology and genomics which studies how genetic differences within a population affect body's response to a drug. After the completion of the Human Genome Project, PGx has become an attractive tool in the attempt to develop personalized medicine that can be adapted to each person's own genetic makeup and lead to a higher therapeutic efficacy. The FDA (and other regulatory agencies) is requesting that sponsors conducting such programs consider providing pharmacogenomic data to the Agency voluntarily, when such data are not otherwise required under the regulations. Such voluntary submissions would facilitate the drug approval process and help identify patients who need dose adjustments or are prone to certain toxic effects (reflected in the drug's label). 

5532. Global Labeling Regulation: Principles and Practices
Suggested prerequisite: Drug Development (5459)
This course provides a detailed analysis of corporate labeling practices in the United States and European Union (EU). It compares and contrasts FDA regulations with more recent EU and International Congress on Harmonization (ICH) regulations, including the impact on corporate labeling documents. A significant portion of the course will be devoted to new guidelines from FDA and the pharmacovigilance guidelines for the EU market and ICH.

5533. Requirements for Product Labeling and Advertising
Prerequisite: Food and Drug Law (5592) or permission of instructor.
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.
Not open to students who have taken RAQA 533.

5534. Regulatory Aspects of Biomedical/Technical Communication
Prerequisite: Drug Development (5459) or Food and Drug Law (5592) or permission of the 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.
Not open to students who have taken RAQA 534.

5535. Advanced Topics in Labeling Development
Prerequisite: Requirements for Product Labeling and Advertising (5533) or permission of the 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.
Not open to students who have taken RAQA 535.

5536. Good Clinical Practices
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 RAQA MS students and for the Drug Development Certificate. It is required for the Certificate in Clinical Trial Management.
Not open to students who have taken RAQA 536.

5537. Clinical Trial Management
Prerequisite: Good Clinical Practices (5536) or permission of the 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.
Not open to students who have taken RAQA 537.

5538. Clinical Drug Safety and Pharmacovigilance (formerly Clinical Safety and Risk Management)
Prerequisite: Good Clinical Practices (5536) or appropriate experience in industry GCPs.
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.
Not open to students who have taken RAQA 538.

5539. Global Clinical Drug Development
This course focuses on the specific regulatory requirements of clinical development in the European Union, Eastern 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 class may be substituted in place of Clinical Trial Management in the CTM certificate.
Not open to students who have taken RAQA 539.

5541. Pharmaceutical Packaging: Technology and Regulation
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 is required.
Not open to students who have taken RAQA 540.

5540. Regulation of Training: Compliance
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).
Not open to students who have taken RAQA 543.

5542. Pharmacopoeia Compliance:  Understanding the Global Impact on RAQA
Prerequisite:  Drug Development (5459) 
Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is applicable. This fundamental – and often misunderstood – principle is an important consideration throughout the drug product life cycle across the bio/pharmaceutical industry. This course provides an in-depth look at the interplay of pharmacopoeias, quality assurance, and regulatory affairs to assist companies in establishing effective processes, partnerships, and tools to maintain appropriate and timely compliance. Topics include why pharmacopoeia compliance is necessary and why it is difficult; a history of pharmacopoeias and harmonization efforts; the revision process for global and national pharmacopoeias and the associated surveillance process used by industry to identify pharmacopoeia changes; the process for monograph development including real-world case studies; and new topics that are on the horizon as the pharmacopoeias continue to evolve. The couse also provides compendial touchpoints during each stage of product development and its importance to regulatory decision making throughout a development program and lifecycle management of a therapeutic product. including innovator, generic, virtual, OTC, and start-up companies who discover, develop, manufacture, and distribute small-molecule drug products, biotherapeutic products, and vaccines, as well as the drug substances and excipients used in these products. Class discussion and hands-on exercises will provide insights on the complexity encountered and possible solutions that companies face every day. The class will focus on small molecule drugs and biotherapeutics and will not include an in-depth overview of herbals or dietary supplements.

5543. Good Distribution Practices (GDPs) 
Prerequisite:  Good Manufacturing Practices (5477)
Students will study the organizational, managerial, technological and regulatory isseus related to the supply chain, logistics, and distribution functions of the pharmaceutical industry. They will be introduced to the tools and technologies that companies use to manage their supply chain, logistics, and distribution functions while maintaining a state of control.  Topics will include both the regulated aspect of distribution as well as key business considerations necessary to get product to the patient.  Students will examine the global economy and the impact pharmaceutical regulations from various regulators across the major markets.  Influential regulatory thinking will be examined such as Quality Risk Management and global trade policies.  Emerging technologies of supply chian monitoring will be discussed in a non-technical way to assist the student in preparation of regulatory modernization efforts.  A series of hot topics will be discussed as case studies to ensure relevancy in a quickly evolving supply chain. 

5544. Regulatory Intelligence
Prerequisites: Drug Development (5459) and Food and Drug Law (5592).
This course examines the fundamentals of global regulatory intelligence, including defining what it is, how it is gathered, and how it can be used to influence regulatory decision making throughout a development program and lifecycle management of a therapeutic product. Students will learn to monitor the legislative and regulatory landscape by assessing various types of accessible information and data. Class discussion and hands-on exercises will provide insights on the collection, analysis, and management of regulatory intelligence. The class will focus on drugs but will also look at other therapeutic products.

5545. Post Approval Changes (PAC)
This course reviews PAC 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 RAQA 545.

5546. Global Pharmaceutical Excipient Regulation
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.
Not open to students who have taken RAQA 546.

5547. Project Management for Clinical Trials
This course focuses on ways to lead, manage and operate clinical trials, starting with the development of a clinical development plan through the completion of supporting clinical studies. Designed to familiarize the clinical research professional and those in related fields with predictable planning practices, the course helps students learn to be effective members of a clinical research team. The material covered will be a mix of basic project management methodology, drug development best practices, and the “soft skills” needed to successfully lead and manage a clinical trial team. Much of the time will be allocated for hands-on application of the topics. Material covers a review of clinical development planning and the design of an appropriate clinical study. The course also discusses the efficient initiation, planning, execution, monitoring/controlling, and closing of a study. Working on teams throughout the course, students develop a Clinical Plan, both in and outside of class, that will be presented at the end of the semester. 

5548. Risk Management for Pharmaceutical and Medical Devices
This survey course focuses on risk management requirements and practices in the pharmaceutical, medical device, and biotech industries. Current regulations and risk management tools will be discussed and utilized to provide students with experience in executing risk assessments.

5571. Post-Marketing Safety Surveillance
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.
Not open to students who have taken RAQA 571.

5572. Vaccines: RA and QA Issues
Suggested prerequisite: Drug Development (5459).
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 RAQA 572.

5573. Pharmacoepidemiology
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.
Not open to students who have taken RAQA 570.

5574. Pharmaceutical Quality Management Systems
Prerequisites Drug Development (5459)
This course provides a detailed overview of Pharmaceutical Quality Management Systemsthrough evaluating federal regulations and guidelines. Emphasis is placed on the development and management of total Quality Systems that meet regulatory expectations. Topics covered include the development, management, usage and maintenance of Standard Operating Procedures (SOPs), Deviation/Non-conformance Systems, Corrective and Preventative Action Systems, Supplier Management Systems, Change Management Systems, Validation, and Process controls via Key Performance Indicators. Focus is placed on the key areas for inspection readiness and robust Quality Systems development. Current guidelines in Pharmaceutical Quality Systems, including Q10, are evaluated. This course presents a total Quality Management Systems approach to the pharmaceutical industry, including traditional pharma (small molecule), biologics, and medical devices.

5575. Regulatory Sciences: Managing the Guidelines for Quality
Prerequisite: strong science background required. Forward resume to RAQA Office for approval.
The International Conference on Harmonization (ICH) revolutionized both the format and content of global regulatory filings, The Common Technical Document (CTD) serves 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. Specifica cross-referencing of documents will be cited. As the term ‘guideline’ implies, such documents should not be generally viewed as regulations. They are essentially ‘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 Quality guidelines will be supplemented by a discussion of the basic scientific principles that may influence implementation. Following an introductory discussion of what a guidance document is and is not, an overview of the ICH process will be shared. Building upon this foundation, the course is designed to focus on the technical aspects of select guidelines associated with filing a CTD for a traditional new chemical entity (NCE). The challenges and opportunities faced in the global implementation of the ICH Quality guidelines will also be discussed.
Not open to students who have taken RAQA 580.

5576. Global CMC Issues and Regulatory Dossiers
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.
Not open to students who have taken RAQA 586.

5577. Global CMCs - Biopharmaceuticals and Other Biologics
This course provides students with an introduction to the chemistry, manufacturing and controls (CMC) topics involved in the development and licensure of biologic products (biopharmaceuticals, vaccines) in the US, Europe and other highly regulated regions. Topics will be discussed from the perspective of Regulatory and QA requirements and expectations. Basic microbiology, cell biology and chemistry concepts will be reviewed with an emphasis on their practical application to product development and RA/QA. The class is designed to orient RA/QA professionals, managers and scientists responsible for biopharmaceutical CMC development and preparation of dossiers to the CMC content matter and technical issues that must be addressed in biologic product development and registration. Topics will include adventitious agents testing, cell and seed bank testing methods and requirements, drug substance production via cell culture, protein and virus purification methods, control and analysis of process impurities, analytical methods and potency testing for characterization and release, strategy for specification setting for release and stability, comparability studies for biologics.

5578. Risk Management and Safety Signaling of Healthcare Products
This course provides a basic understanding of the principles involved in developing, negotiating, and implementing Risk Management Plans. While the focus will be on the EU and US, the general principles are applicable across multiple jurisdictions. Starting with the background needed to develop effective benefit-risk management programs, the course will provide an overview of the many factors contributing to the development of such programs. The sources and methods of interpretation of data as part of a risk management strategy will be included. Importantly, students will acquire practice in developing sections of risk management programs, enabling them to acquire the skills necessary in evaluating the utility and reliability of such programs

5579. Regulatory and Legal Basis of Pharmacovigilance 
Suggested prerequisite: Post Marketing Safety Surveillance (5571) or Clinical Drug Safety and Pharmacovigilance (5538).
This course reviews key regulations and the regulatory framework that influence the development and management of a pharmacovigilance system. While the main emphasis is on ICH regions, systems in emerging countries are also included, including the impact of the changing regulatory landscape on both manufacturers and regulators. Discussions include partnership agreements, pharmacovigilance aspects of due diligence, licensing and acquisitions, and product liability issues. In addition, students learn key aspects of drug safety and pharmacovigilance; FDA and EMA guidances that shape pharmacovigilance practices; the merits and deficiencies in the U.S. AERS database system in comparison to the European Eudravigilance data base; differences between the U.S. periodic reports (including periodic safety update reports, development safety update reports, and others as mandated); the impact of key regulatory reforms on pharmacovigilance (Brexit and GDPR); and product liability issues.

5591. Global Regulatory Affairs
Prerequisite: Food and Drug Law (5592) or Drug Development (5459), or permission of the instructor.
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. 
Not open to students who have taken RAQA 591.

5592. Food and Drug Law
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 MS in RAQA, the Drug Development Certificate, and the Medical Device Certificate.
Not open to students who have taken RAQA 592.

5594. Regulation of Dietary Supplements and Functional Food
Functional foods and dietary supplements have been a fast growing segment of the food market for the last half a decade owing to the aging demographics and scientific research demonstrating their effect on health. Regulation and judicial decisions have been influential for dietary supplement companies in producing and marketing their products. An understanding of how these regulation work and what influence they have on dietary supplement regulatory policy is critical. This course will provide information on the history of the regulation in the US and an in-depth look at the current regulatory outlook for these products in the US and in other select countries/regions.
Not open to students who have taken RAQA 594.

5595. Food Law
While Food and Drug Law (5592) briefly touches on food law, this course examines the major federal statutes and regulations applicable to food in more detail through class discussion and workshops. While emphasis is placed on the role, policies, and regulations of FDA, the practical working relationships and obligations between the food industry, the USDA, and other government agencies at the state and local level are also examined. Pertinent landmark judicial decisions and concepts are presented relating to regulation of food and enforcement action against adulterated food. The Food Safety Modernization Act (FSMA), the most sweeping reform of U.S. food safety laws in more than 70 years, is studied, including new enforcement tools granted to FDA. Preventive Controls for Human and Animal Food, which are revolutionizing food safety programs across the globe, are extensively studied and illustrated. The student project focuses on conducting a Hazard Analysis for a particular food product.

5596. Food Labeling and Regulatory Affairs
This course provides students with an in-depth understanding about how food in the U.S. must be labeled. Students learn about the food label and its mandatory elements, as well as problems associated with incorrect or deceptive labeling. Rules issued under the Food Safety Modernization Act (FSMA), such as Sanitary Transportation, Protection Against Intentional Adulteration, Produce Safety, Foreign Supplier Verification Program, and Accredited Third Party Certification are thoroughly studied. The course describes regulatory affairs functions in the food industry including facility registration, importing, FDA inspections, recordkeeping, reporting, and recalls. Workshops throughout the course illustrate important labeling and FSMA concepts.

5597. Food Good Manufacturing Practices (GMPs)
This course covers FDA-enforced cGMPs (current Good Manufacturing Practices) through class discussion and workshops. Food safety regulations under the Food, Drug, and Cosmetic Act are covered as well as their impact on personnel, facilities, equipment, and production. Major foodborne pathogens are discusssed, followed by control strategies, such as formulation and thermal processing. Emphasis is placed on preventing foodborne hazards via an understanding of sanitation measures, allergen control, acidification, and low acid canning, A risk-based approach to controlling hazards is presented using HACCP (Hazard Analysis and Critical Control Points) principles, from which new Preventive Controls regulations were derived. The student project focuses on evaluating food safety concerns when an FDA inspection reveals a total quality failure.

5599. Clinical Aspects of Pharmaceutical Medicine
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. Students may take Pharmaceutics 5599 and 5602 in either order.
Not open to students who have taken RAQA 599.

5601. Industry Interactions with FDA and Health Authorities
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.
Not open to students who have taken RAQA 601.

5605. Advanced Topics in Food and Drug Law
Prerequisite: Food and Drug Law (5592) or permission of the instructor.
This course expands the regulatory concepts covered in Pharmaceutics 592. Each semester the specific topics change.
Not open to students who have taken RAQA 605.

5606. Regulatory Strategy: Discovery to Approval
Prerequisites: Drug Development (5459) and IND/NDA Submissions (5495).
A regulatory strategy is a key component of therapeutic product’s development. It is imperative to create a regulatory strategy early in the development process to consider such critical factors as the correct indication, size of the treatment population, cost and extent of clinical studies, and potential market for the product under consideration. The regulatory strategy should be developed as soon as the target product profile (TPP) is determined. Considering the enormous investments companies incur when launching new products, any regulatory strategy must be well thought out, reviewing existing patents, current regulatory intelligence, and pricing issues. This course covers the development and execution of product approval strategy from discovery to marketing approval. Class discussions include analyses of successful product launches as well as ones the failed due to insufficient regulatory strategies.

5611. Advanced Topics: Regulation of Advertising & Promotions
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.
Not open to students who have taken RAQA 611.

5612. Bioethics for Pharmaceutical Professionals
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.
Not open to students who have taken RAQA 610.

5615. Project Management for Pharmaceutical Professionals
Prerequisite: at least four courses in the RAQA program, including Drug Development (5459) and Food and Drug Law (5592).
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.
Not open to students who have taken RAQA 615.

5616. Accelerated Regulatory Pathways:  From Fast Track to Reliance:
Prerequisite:  Drug Development (5459)
Facilitated Regulatory Pathways (FRPs) are regulatory approaches used by ministries of health to accelerate the development and assessment of new products or reduce the burden of duplicative regulatory activities, helping to make the development and assessment of safe, effective, quality medicines more efficient and timelier often through reliance or recognition mechanisms, thereby promoting efficient access to important medicines worldwide. Students will learn about the evolution of and distinguish the characteristics FRPs used by ICH and maturing regulators. Participants will learn how to apply these to real-world global drug development programs. They will investigate how to apply the concept of Return on Investment for the use of FRPs, as these apply to companies and agencies and will gain an understanding of how the data requirements for FRPs and the acceleration of authorizations through these pathways have implications for agencies, patients, payers and health technology assessment bodies. A combination of presentation styles will be used: lecture by the instructor and invited international speakers; interactive questions will be posed by the presenter to the students; each week selected students will be asked to prepare a10 minute overview of a recently published manuscript/research paper/policy document. The document will relate to the topic of the session and will help students familiarize themselves with important advances in the field of FRPs; an in-session discussion will be presented by the course instructor based on the reading homework- practical applicability of the learnings from the publication will be stressed. 

5618. Clinical Data Management 
Prerequisite: Drug Development (5459) and Good Clinical Practices (5536).
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. Not open to students who have taken RAQA 618.

5621. Regulatory Bioanalysis
Prerequisite: a background in science is recommended
Benefitting both pharmaceutical quality professionals and scientists working in the laboratory, this course covers several broad topics: (1) a high-level overview of the basic science behind chromatographic and ligand-binding assays used in routine quantitative analysis of biological samples that provide data to support pharmaceutical drug/biological product approval; (2) detailed instruction of FDA and EMA regulations and guidances that govern bioanalytical method development, validation and application in routine sample analysis; (3) ‘best practices’ recommended for implementing quality management systems in a bioanalytical laboratory; and, (4) discussion of approaches to address common problems that may arise during method validation and sample analysis. This course addresses subjects not routinely covered in other RAQA courses, including the quantitative analysis of biological samples (e.g. plasma, serum, urine) from nonclinical animal and human clinical studies. A large part is devoted to exploring and understanding quality principles in the bioanalytical laboratory required to withstand regulatory inspection.

5622. Unit Operations
Prerequisites: Students are expected to have a strong science background, including familiarity with chemistry, biology, and physics. Students should also have a basic understanding of pharmaceutical manufacturing processes. In addition, students need an aptitude in basic mathematical principles, including the ability to do calculations.
This course will expose students to the current process steps common to the manufacture of modern pharmaceuticals. In particular, the key variables for each step of a process will be discussed. Each class will feature a specific process common to pharmaceutical processing. Specific variables will be discussed, including an analysis of each process.
At the end of the course the student should be able to describe a process by a series of smaller operations, describe the key variables for each small operation, identify key limitations of time and resources in proposed processes, and provide constructive improvements to complex processes.

5625. Process Analytical Technology (PAT)
Prerequisite: Students are expected to have a science background, including familiarity with chemistry. Students should also have a basic understanding of pharmaceutical manufacturing activities.
The course provides an immersion in topics associated with Process Analytical Technology (PAT) with the intention of creating a pragmatic working knowledge of the subject. It will cover the regulatory environment, quality control and assurance aspects, business drivers, analytical methodologies (e.g., spectroscopy, chromatography, and sensors), chemometrics and multivariate analysis, process control, real-time release, and a range of applications (e.g., biologics, vaccines, and solid dose pharmaceuticals). Innovative and abstract thinking will be emphasized.

5627. Statistical Design of Experiments (DOE)
Prerequisite: familiarity with basic math. A statistical program (Minitab) will be used.
This course exposes students to the use of statistical methods for designing optimal processes used in industry, extensively using data sets and data charting. At the end of the course the student should be able to: create an experimental plan to optimize a process; create a screening study to limit the number of experiments; use surface methodology to set process specifications; and use specialized methodology for material analysis.

5629. Process Monitoring
To learn more: http://qara-apache.temple.edu/snee/pm5629_files/default.htm
Students are introduced to state-of-the art process monitoring and controls used in the pharmaceutical and biotechnology industries. Students will be shown how process control is an integral part of using Quality by Design to build quality into the product. A discussion of process flowcharting and improvement is followed by an introduction to the use of control charting and process capability analysis to assess the stability and capability of processes. These concepts, methods and tools are then integrated into a process performance and product quality monitoring and improvement system. The course concludes with an introduction to process improvement using lean and Six Sigma methods. The Minitab statistical software is used to enable the statistical calculations involved. Students deepen their understanding of the subject by completing a project that involves the collection and analysis of data measuring the performance of an operational process. At the end of the course students will be able to collect process monitoring data, analyze process data to assess process stability and capability, identify opportunities for improvement, conduct studies to solve problems and create process improvements, and use statistical software to analyze process data.

5650. Special Topics in RAQA (topics vary and will be published in the schedule of classes each semester as needed.

Spring 2022 Special Topics Course:

Critical Analysis of Media Coverage of the Pharmaceutical Industry: This course consists of critical analyses of recently published non-fiction works which focus on events and cases within the pharmaceutical industry. Factual documentation of actual events will provide the opportunity to analyze the works’ impact on the pharmaceutical industry and its employees, plus healthcare professionals and patients. Classes will consist of cumulative, in-depth, comparative analyses and discussions using current pharmaceutical industry regulations and guidances. Utilizing critical thinking skills, students will perform a full analysis and critique of the chosen text(s), studying each author’s approach, evidence presented, applicable pharmaceutical regulations and guidances, as well as the resultant impact on the pharmaceutical industry and intended target audience.  Suggested prerequisites:  5459. Drug Development, 5477. Good Manufacturing Practices, and 5592. Food and Drug Law.

5655. Analytical Chemistry in Pharmaceutical Laboratories
Prerequisite: Drug Development (5459). Students are expected to have some laboratory background in chemistry or related science and familiarity with laboratory practices.
Analytical chemistry plays a critical role in pharmaceutical product development. An effective laboratory system must ensure that quality data is generated, so that raw materials and finished products can be released. The analytical chemist develops methods, evaluates data, reports results, and writes development reports, according to regulation and compliance standards.
This course provides an overview of laboratory operations and the critical role of an analytical scientist. It reviews regulatory requirements for pharmaceutical lab operations and provides a framework for quality in a drug development laboratory. Although the course is designed for pharmaceutical scientists, many of the operations discussed are applicable to the chemical and environmental industries.

Pharmaceutical Sciences Courses
The following courses in Pharmaceutical Sciences are open to RAQA students with strong science backgrounds. This consists of a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must fax their resume to 267.468.8565 for written permission to register.

5492. Production of Sterile Products
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.
Not open to students who have taken Pharmaceutics 492.

5501. Development of Sterile Products
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.
Not open to students who have taken Pharmaceutics 501.

8002. Pharmaceutical Analysis
The applications of chemical analysis to pharmaceuticals and pharmaceutical manufacturing are discussed. Classical separation methods, including GC, HPLC, and NMR, as well as hyphenated techniques (GC-MS and HPLC-MC), are explored. Students are introduced to immunologic, antibody-based procedures and emerging technologies.
Not open to students who have taken Pharmaceutics 411.

8003. Preformulation - Small Molecules (Formerly Pharmaceutical Manufacturing I: Preformulation/Formulation)
This course presents techniques relevant to all aspects of preformulation and formulation phases, including specifics of powder characterization, properties of particulate systems for manufacturability, milling, evaluation of crystal structures, thermal methods, DSC, and amphorates, hygroscopic potential of solids during processing, polymorphism, solubility, compactibility, relevant biopharmaceutical factors, dissolution rates as well as principles and mechanisms of all aspects of incompatibility and stability testing.
Not open to students who have taken Pharmaceutics 406.

8004. Manufacturing - Solid Dosage Forms - Small Molecules (Formerly Pharmaceutical Manufacturing II: Solid Dosage Forms)
This course presents processing and principles that apply to solid dosage form design and product development. Conventional and specific techniques of industrial pharmacy, including direct compression, wet and dry granulation, fluid bed and coating operations, tableting machine instrumentation and compactibility measurements, and solid product evaluations are presented. Novel oral dosage forms and technologies associated with solid products as well as product quality and performance assessment are covered.
Not open to students who have taken Pharmaceutics 407.

8005. Pharmaceutical Biotechnology
This course introduces students to pharmaceutical biotechnology, biophysical and chemical aspects of biotech products, and their pharmaceutical formulations and clinical applications. Amino acids, proteins, peptides and nucleotides are of particular interest. The principles of pharmaceutical formulations and physicochemical evaluation of formulations will be discussed. Pharmacokinetics of biologics and current analytical methods used in pharmaceutical biotechnology are included. In addition, the course provides an introduction to biopharmaceuticals that encompass a variety of technologies ranging from products derived from natural sources, peptides, therapeutic proteins/monoclonal antibodies, oligonucleotide therapeutics (e.g. antisense, ribozymes, apatmers, siRNA), gene therapy and special issues in drug delivery. The course will begin with a review of the molecular, biochemical, pharmaceutical underpinnings that support each of the technologies and will move into a more detailed discussion of each therapeutic technology. Preclinical and clinical development, safety, efficacy and manufacturing issues will be discussed. 
Not open to students who have taken Pharmaceutics 475.

8006. Physical Pharmacy I - offered spring in even-numbered years
Prerequisites: Students are expected to have a strong science and math background and a previous course in physical chemistry.
The emphasis of this course is to form a bridge between the concepts of physical pharmacy and the application of pharmaceutical sciences. Students will gain understanding of the aspects of intermolecular forces, physical properties of solutions, ionic equilibria, buffers and isotonic solutions, solubility and partition pharnomena, complexation and protein binding, reaction kinetics, mass transport, dissolution phenomena, interfacial phenonmena, and rheology. Pharmaceutical applications based on the basic principles will be discussed as well. Students will be expected to be able to apply the basic concepts from this course to typical formulation and stability issues of pharmaceutical dosage forms.
Not open to students who have taken Pharmaceutics 485.

8007. Applied Biopharmaceutics
This course presents the interrelationship of the physicochemical properties of the drug and the dosage form to the route of administration to the rate and extent of systemic drug absorption. It covers drug absorption mechanisms and physiological and GIT constraints on dosage form transit and bioavailability, effect of formulation parameters, dissolution methodologies, in-vitro/in-vivo correlation of drug product performance, as well as PAC, ICH and FDA guidelines on development and approval processes. Formulation strategies are provided for optimum therapeutic outcome via application of pharmaceutical sciences to the design of drug delivery systems.
Not open to students who have taken Pharmaceutics 410.

8111. Introduction to Toxicology
Toxicology is a multi-disciplinary science focused on the adverse effects of chemicals, drugs, and environmental agents. In the first part of this course the basic principles of toxicology will be covered, including dose response relationships, mechanisms of toxicity and exposure. In the second part, target organs of toxicity will be presented with an overview of anatomy and physiology of different target organs (e.g. liver, kidney), as well as organ-specific response to toxic insult. In the final segment, students will be exposed to a variety of areas of applied toxicology, including risk assessment, clinical and forensic toxicology, chemical carcinogenesis, reproductive toxicology and the role of toxicology in drug development.

8478. Modified Release Dosage Forms
This course covers the fundamentals of various extended release dosage forms and their modification for use in particular dosage formulations. Biopharmaceutical and pharmacokinetic aspects of extended-release dosage forms are discussed, including an overview of polymeric excipients used in formulations. Current commercial products under development are included.
Not open to students who have taken Pharmaceutics 478.

8582. Physical Pharmacy II
This course focuses on the theory and application of pharmacokinetics (PK) and pharmacodynamics (PD) and PK-PD modeling. Topics include linear and nonlinear PK, compartmental and non compartmental modeling, metabolite kinetics, modeling
concepts, and PK-PD.

Special Note:

The following courses are required for the MS in Pharmaceutical Regulatory Sciences:

• Pharmaceutical Manufacturing I: Preformulation/Formulation (8003)
• Pharmaceutical Manufacturing II: Solid Dosage Forms (8004)
• Pharmaceutical Biotechnology (8005)
• Physical Pharmacy (8006) - offered only in spring of even-numbered years
• Regulatory Sciences: Managing the Guidelines for Quality (5575)
• IND/NDA Submissions (5495)
• Facilities, Utilities and Equipment (5468)
• Chemistry, Manufacturing and Controls (CMC) (5576 or 5577)

Electives: One elective in Pharmaceutical Science and One elective in RAQA from the following:

Pharmaceutical Science electives (students must take one):

• Pharmaceutical Analysis (8002)
• Applied Biopharmaceutics (8007)

RAQA electives (students must take one)

• High Purity Water Systems (5478)
• Cleaning Validation (5516)
• Computerized System Validation (5498)
• Vaccines: RA and QA Issues (5572)
• Biologics/Biosimilars (5515)
• Regulatory Strategy (5606)

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Special Note:
The following RAQA courses may be taken as electives for students pursuing the Non-Thesis Master’s in Pharmaceutics:

5451. Statistical Quality Control
5458. Validation of FUE (Facilities, Utilities and Equipment)
5469. Pharmaceutical Laboratory Quality Systems and Operations
5471. Biotechnology: Bioprocess Basics
5474. Process Validation (either RAQA 5474 or Pharmaceutics 8484. Students may not receive credit for both courses.)
5477. Good Manufacturing Practices OR 5479. Advanced GMPs – Defining “c” (Students may select 5477 or 5479 but not both courses.)
5478. High Purity Water Systems
5493. Sterilization Processes: Manufacturing
5499. Pharmaceutical Drug Dosage Forms
5501. Development of Sterile Products
5512. Microbiological Concepts in Pharmaceutical Manufacturing
5575. Regulatory Sciences: Managing the Guidelines for Quality
5576. Global CMC Issues and Regulatory Dossiers
5577. Global CMCs – Biopharmaceuticals and Other Biologics
5622. Unit Operations
5625. Process Analytical Technology (PAT)
5627. Statistical Design of Experiments (DOE)
5629. Process Monitoring
5655. Analytical Chemistry in Pharmaceutical Laboratories