MHS Regulatory Science Track

The M.H.S. regulatory science track is a 31-credit program (inclusive of the 10 hours of required M.H.S. core credits) designed for preprofessional students who are seeking further specialization in regulatory sciences and for working health care professionals who are looking to enhance their standing within this growing and evolving field of study.

Educational programming will provide students with

  • a working understanding of regulatory history and theory,
  • federal and state regulatory structures relevant to health care products and professional practices,
  • regulatory compliance methods in the health care industry,
  • health care product patent-licensing processes and
  • the common research methods used in supporting product-licensing applications.

The primary goal of this degree program will be to prepare students for taking on significant roles within government agencies, pharmaceutical and biotechnological industries and health care provider organizations, as well as in other sectors of the health care industry where compliance and regulation are crucial. The program will allow students to develop a comprehensive understanding of the protocols, procedures, statistical analysis, assessment or risk/benefit, documentation and legal and ethical concerns that play a critical role in the day-to-day responsibilities of the field.

Upon completion of this program, students will be able to:

  • Demonstrate the constituent elements of federal and state regulations of healthcare delivery and manufacture and distribution of pharmaceuticals and biologics in the U.S.
  • Compare and contrast the governmental regulatory approaches for manufacture and distribution of pharmaceuticals and biologics in the U.S., Canada, Europe, South America and Asia.
  • Generate statistical analyses and reports acceptable to governmental regulatory agencies in the U.S., Canada and Europe.
  • Evaluate regulatory applications for new products or professional practices against applicable regulations, standards and guidances.
  • Discern the moral, legal, ethical and financial implications of research data or licensing applications for specific pharmaceutical or biological products.
  • Detect legal and regulatory requirements that can pose harm to patients and undue disruption to health care operations.
  • Identify conflicting regulations at local, state and federal levels and evaluate ways to reconcile them for affected constituencies.
  • Identify gaps in regulatory processes for particular health care products and services and propose policy solutions.

Graduates who achieve these objectives will be prepared to assume responsibilities requiring competencies associated with Level I and Level II of the Regulatory Science Professional Development Framework produced by the Regulatory Science Professional Society. Because most of the graduates of this program will have formal education in pharmacy or other health care professions, they will bring added dimensions to the knowledge and skills they acquired in regulatory sciences. Graduates will find rewarding career opportunities in health care provider organizations, health care consultancies, health care research and manufacturing industries, insurance providers, pharmacy benefit managers and state and federal government agencies.

This program is offered under the auspices of the FDU School of Pharmacy, Maxwell Becton College of Arts and Sciences, Florham Campus, Madison, New Jersy.