CERTIFICATE IN REGULATORY AFFAIRS

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Overview

The laws and regulations related to the development and commercialization of drugs, biologics and medical devices are often complex and continually changing.  Regulatory Affairs professionals are assuming key positions at the highest reaches of the biopharma industry as they provide strategic and operational guidance in meeting the requirements of the FDA and other U.S. and international regulatory bodies.

The well-prepared Regulatory Affairs professional is expected to have a solid foundation in science, informatics, law, policy, and business.  This online certificate provides students with the practical information and insights they will need to participate effectively at every stage of a product’s life cycle. 

The 15-credit online academic certificate program is structured to fit into the busy schedules of working professionals while maintaining the highest degree of academic rigor and faculty-student interaction. Click here to view courses for this certificate. Through graduate course work conducted by faculty at UMDNJ’s School of Public Health, Graduate School of Biomedical Sciences and School of Health Related Professions, you’ll be exposed to:

• Study design and statistical analysis
• Comprehensive discussion of U.S. and international food and drug law
• Concepts of quality control and quality assurance and validation
• Issues in the ethical conduct of clinical trials and post-marketing activities

Who Should Apply?

This program is open to those who have previously earned a baccalaureate degree. Regulatory Affair professionals seeking to enhance their skills or persons interested in transitioning to the field will benefit from the coursework. Students with backgrounds in chemistry, biology, engineering, or healthcare, including those with advanced degrees, are also appropriate candidates for the certificate.

Learning Advisement

Not sure if this certificate is right for you? Take advantage of our Learning Advisement feature and get answers to your specific questions about coursework requirements, applicability of the coursework to your career goals, information on other offerings at UMDNJ and much more. Call (973) 972-6482 or send inquiries to biopharma@umdnj.edu and you will receive a detailed response within three business days.

The Curriculum

The Certificate in Regulatory Affairs provides you with a solid foundation in the letter and spirit of U.S. and international laws, guidelines, and regulations that apply to drugs, biologics, and medical devices. The 15-credit online curriculum consists of four core courses and one elective chosen from a wide array of subjects. Most students will choose to take one or two courses per semester. Read more about web-based learning.

CERTIFICATE COURSES: Click on the course title for additional information.
CORE
	Clinical Trials Overview: Methodology and Practice, BPHE 5310P
	Regulatory Requirements in Clinical Investigations, BPHE 5521P
	Food and Drug Law, BPHE 5110P
	Adverse Event Reporting and Postmarketing Activities, BPHE 5725P
	Additional Requirement: All students must complete the University-wide online ethics course.

ELECTIVES (choose one)
	Applied Biostatistics, BINF 5400
	Applied Clinical Trials, BPHE 6352P
	Biomedical Informatics for Clinical Trials Management, BINF 5075
	Cultural Diversity in Clinical Trials, BPHG 5800G
	Concepts of Quality Control, Quality Assurance and Validation, BPHE 5720P
	Data Analysis and Interpretation, IDST 6121
	Data Analysis and Interpretation II, IDST 6122
	Health Care Policy, HSAP 0661 (in-person lecture)
	Healthcare Policy and Planning, IDST 6120
	Health Ethics and Law, HSAP 0616 (in-person lecture)
	Introduction to Biostatistics, PHCO 0504 (in-person lecture)
	Overview of Disease Processes and Treatment, BPHE 5510P
	Principles and Methods of Epidemiology, PHCO 0502-W

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