Krieger School of Arts and Sciences Center for Biotechnology Education | Center of Excellence in Regulatory Science and Innovation

Download the 2014-2015 Academic Catalog

MS in Regulatory Science

410.649 Introduction to Regulatory Affairs
This course provides an overview of RA, its effect on product development. Topics include: RA history, regulatory agencies, how to access regulatory information, drug submissions, biologics submissions, medical device submissions, GLP, GCP, GMP, and FDA inspections.

410.651 Clinical Development of Drugs and Biologics
This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently

410.673 Biological Processes in Regulatory Affairs
This course provides an overview of the biological processes and laboratory techniques utilized for the discovery, development and evaluation of therapeutic drugs

410.676 Food and Drug Law
The class will discuss administrative procedures followed by the FDA. The course includes an overview of the drug, biologic and medical device approval processes and the regulation of food and dietary supplements.

410.679 Practicum in Regulatory Science
This integrative case-based course will focus on applying knowledge gained from previous courses in the MS Bioscience Regulatory Affairs program to actual cases from the U.S. Food and Drug Administration

410.683 Introduction to cGMP Compliance
Students will learn the scope and history of the regulations, industry-standard implementation strategies and “bestpractices” approaches, and FDA’s current expectations. Students will also learn to apply practical solutions to the regulatory issues faced in the pharmaceutical and biotech industries today

Concentration in Regulatory Affairs

410.606 Clinical Trial Management
The goal of this course is to provide students with a functional understanding of all the operational aspects of a clinical study.

410.627 Translational Biotechnology: From Intellectual Property to Licensing
This course provides an extensive overview of a process for development of a pharmaceutical by a biotechnology company or pharmaceutical company. The course emphasizes the importance of intellectual property, the basic sciences underpinning the development of a product, and the importance of the interaction between a company and the Food and Drug Administration (FDA)

410.648 Clinical Trial Design and Conduct
Through a case study approach, this course will cover the basic design issues of clinical trials, specifically targeting the Protocol, Case Report Forms, Analysis Plan, and Informed Consent.

410.651 Clinical Development of Drugs and Biologics
This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently.

410.675 International Regulatory Affairs
The course provides a review and analysis of the pharmaceutical/biotechnology product approval processes within the world’s major markets

410.677 Preparing a Successful Submission
Beginning with the IND and moving through the NDA this course provides a comprehensive review and discussion of the IND and NDA and all related submissions required for life cycle maintenance of the applications.

410.678 Marketing in a Regulated Environment
This course is designed to help students, understand, use, and comply with the laws, regulations, and policy guidance documents governing advertising and promotion of products regulated by the Food and Drug Administration (FDA).

410.682 Validation in Biotechnology
This course will introduce the fundamentals of validation, validation master planning, resource management, types of validation and the associated documentation, departmental roles and interaction, and the differences between commissioning and validation.

410.686 QA/QC for the Pharmaceutical and Biotechnology Industries
Students will be presented with a comprehensive overview of the current best practices in quality assurance and quality control. Students will also be exposed to the most recent theories and expectations from the Food and Drug Administration.

410.687 Ethical, Legal, and Regulatory Aspects of the Biotechnology Enterprise
This course provides an overview of the important ethical, legal and regulatory issues that are critical to the biotechnology industry.

410.690 Technical Writing in a Regulated Environment
In this practical course, students will learn both the basic concepts and the steps involved in writing documents and reports commonly associated with compliance and regulatory requirements in the Biotech and Pharmaceutical industries.

410.691 Drugs, Medical Devices, and Government
The course will explore the administrative roles of each agency and those instances where an intersection or overlap of activities of the agencies occurs.

410.701 Introduction to Food Safety
This course is designed to understand the legal and regulatory complexities of the regulation of food products in the United States. The prone issues including regulatory compliance in food safety and Hazard analysis and Critical Control points (HACCP) are among major issues to control the food supply.

410.702 Biomedical Software Regulation
This course describes how the U.S. government regulates software used in delivering healthcare including the regulations utilized by the Food and Drug Administration (FDA), as well as, the Center for Medicare and Medicaid Services (CMS).

410.715 Medical Device Regulation
This course provides a comprehensive introduction into medical devices and how they are regulated by the US Food and Drug Administration (FDA)

410.727 Regulatory Strategies in Biopharmaceuticals
This course will discuss different regulatory strategies that several players of the US biopharmaceutical industry have employed.

410.729 Regulatory and Economic Fundamentals of Drug Pricing and Reimbursement
This course will examine the elements of pharmaceutical pricing and reimbursement to better understand accepted drug pricing models, and how both government and industry look at drug pricing and reimbursement.

Concentration in Legal/Regulatory Affairs

410.606 Clinical Trial Management
The goal of this course is to provide students with a functional understanding of all the operational aspects of a clinical study.

410.650 Legal Aspects of Biotechnology
This course is an overview of the major legal principles that arise to protect and market biotechnological inventions and of the procedures required as a biotech company is established, evolves and brings products to market.

410.651 Clinical Development of Drugs and Biologics
This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently

410.684 Technology Transfer & Commercialization
This course is an introduction to the multidisciplinary aspects involved in the process of bringing technical developments, particularly research emanating from universities and other nonprofit organizations, into commercial use.