Rutgers, The State University of New Jersey
Graduate School New Brunswick
About the University
Graduate Study at the University
Other Graduate Study at the University
Degree Programs Available
Financial Aid
Student Services
Academic Policies and Procedures
Degree Requirements
Programs, Faculty, and Courses
Course Information
Actuarial and Statistical Analysis
African Studies 016
Analytics: Discovery Informatics and Data Sciences
Anthropology 070
Applied Computing
Art History 082
Arts, Visual and Theater
Asian Studies 098
Atmospheric Science 107
Biochemistry 115
Bioenvironmental Engineering 116
Biomedical Engineering 125
Biotechnology 126
Biotechnology and Genomics
Business and Science 137
Cell and Developmental Biology 148
Cellular and Molecular Pharmacology
Chemical and Biochemical Engineering 155
Chemistry and Chemical Biology 160
Chinese 165
Cinema Studies 175
Civil and Environmental Engineering 180
Classics 190
Cognitive Science 185
College Teaching 186
College and University Leadership 187
Communication, Information and Library Studies 194
Communication Studies
Comparative Literature 195
Computational and Data-Enabled Science and Engineering 199
Computer Science 198
Cultural Heritage and Preservation Studies (CHAPS)
Curatorial Studies
Data Science (Statistics Track) 954
Drug Discovery and Development
East Asian Languages and Cultures 217
Ecology and Evolution 215
Economics 220
Education 300
Educational Psychology; Educational Theory, Policy, and Administration; Learning and Teaching
Electrical and Computer Engineering 332
Endocrinology and Animal Biosciences 340
Energy 335
Engineering Management
English, Literatures in (English 350, Composition Studies 352)
English as a Second Language 356, American Language Studies 357
Entomology 370
Environmental Change, Human Dimensions of 378
Environmental Sciences 375
Exposure Science
Financial Statistics and Risk Management 958
Food and Business Economics 395
Food Science 400
French 420
Genetic Counseling
Geography 450
Geological Sciences 460
Geospatial Information Science 455
Geospatial Information Systems
German 470
Global Agriculture
Global Sports Business 475
Graduate Student Professional Development 486
Higher Education 507
Historic Preservation
History 510
Horticulture and Turfgrass Science
Human Resource Management
Industrial Mathematics
Industrial Relations and Human Resources 545
Industrial and Systems Engineering 540
Information Technology
Interdisciplinary Ph.D. Program 554
Italian 560
Jewish Studies 563
Kinesiology and Applied Physiology 572
Labor and Employment Relations
Landscape Architecture 550
Latin American Studies
Library Studies
Linguistics 615
Literature and Language 617
Literatures in English
Materials Science and Engineering 635
Mathematical Finance 643
Mathematics 640, 642, 644
Mechanical and Aerospace Engineering 650
Medical Device Design and Development
Medicinal Chemistry 663
Medieval Studies 667
Microbial Biology 682
Microbiology and Molecular Genetics 681
Molecular Biophysics 696
Molecular Biosciences 695
Music 700
Neuroscience 710
Nutritional Sciences 709
Oceanography 712
Packaging Engineering 731
Perceptual Science 714
Personal Care Science
Pharmaceutical Engineering
Pharmaceutical Science 720
Pharmaceuticals and Clinical Trials Management 725
Certificate Program
Pharmacology, Cellular and Molecular 718
Philosophy 730
Physics and Astronomy 750
Physiology and Integrative Biology 761
Planning and Public Policy 762
Plant Biology 765
Political Science 790
Psychology 830
Psychology, Applied and Professional
Public Health 832
Public Policy
Quality and Reliability Engineering
Quantitative Biomedicine 848
Quaternary Studies 855
Religion 840
Russian, Central and East European Studies 859
Science and Technology Management 885
Social Networking and Media
Social Work 910
Social Work: Administration, Policy and Planning, and Direct Practice
Sociology 920
Spanish 940
Statistics and Biostatistics 960
Theater Arts
Toxicology 963
United Nations and Global Policy Studies
Urban Environmental Analysis and Management
Urban Planning, City and Regional
User Experience Design (UXD)
Visual Arts
Women's and Gender Studies 988
Writing for Graduate Students 355
Research Centers and Institutes
Divisions of the University


Camden Newark New Brunswick/Piscataway
  Graduate School-New Brunswick 2017 Programs, Faculty, and Courses Pharmaceuticals and Clinical Trials Management 725 Requirements  
Graduate School-New Brunswick

The certificate requires completion of 15 credits, including three required courses (9 credits) and two elective courses for 6 credits.

The required courses are:

16:137:510 (F) Drug Development from Concept to Market (3)

Provides an overview of the process of drug development in the pharmaceutical industry. The drug development pipeline from target selection through clinical trials and marketing will be discussed, employing expert guest lecturers from different stages of the developmental process. An interactive case study format will be used to study the developmental history of specific drug candidates throughout the course, starting with the target identification and method of drug discovery, through the development of lead compounds, patent filings, drug refinement, clinical trials, regulatory approvals, and marketing processes. Students will develop industry-specific teamwork skills as well as continuing their development of oral and written communication skills.

16:137:580 (S) Practical Aspects of Clinical Trial Design/Conduct (3)
Provides extensive training in clinical research and clinical data management. It incorporates end-to-end training for all clinical research areas with a special focus on clinical data management processes, documentation, and clinical data management systems. The course includes extensive practical sessions to provide rigorous hands-on experience on a clinical data management system (CDMS), which is widely used in the pharmaceutical industry today. It also provides hands-on experience in protocol development, case report form development, clinical database planning, database design, clinical data entry, clinical data definition, discrepancy management, and writing validation procedures.

16:137:582 (S) Fundamentals of Regulatory Affairs (3)
Provides an overview of the laws, regulations, and regulatory agencies governing pharmaceuticals, devices, biologics, and combination products marketed in the United States and in the world. The course also discusses the historical context in which the FDA evolved; its structure and its relationship with other U.S. regulatory agencies. Provides an overview of market clearance pathways for drugs, biologics, medical devices, and combination products so that the development and delivery of safe and effective health care products can be expedited. Emphasizes teamwork, oral communication skills, and written communication skills.

Two elective courses must be taken for the certificate. The full list of elective courses is available at See also the entry in this catalog for Business and Science 137.

Students must attend at least six colloquia in the professional science master's program for the certificate.
For additional information, contact RU-info at 732-932-info (4636) or
Comments and corrections to: Campus Information Services.

2017 Rutgers, The State University of New Jersey. All rights reserved.
Catalogs Home