Skip to content

Regulatory Affairs and Health Policy Program Overview

The Goal:

For students to develop a robust understanding of pharmaceutical and healthcare regulation, healthcare systems, legislative procedures and quality improvement in order to create effective and lasting healthcare policy, processes and reform.

Program Highlights:

  • Courses led by industry experts with extensive experience in drugs, devices, biologics, and healthcare policy and regulatory affairs
  • Courses offered in-person, online or both
  • 10 course Master’s degree
  • 3 course Graduate Certificate of Regulatory Affairs
  • 3 course Graduate Certificate of Healthcare Policy

Regulatory Affairs & Health Policy: The Foundation of a High-Quality, Safe & Equitable Healthcare System

Healthcare has taken center stage over the last decade due to ongoing political debates at the state and federal levels, rapid technological innovations, and a growing awareness of health disparities throughout the U.S. and around the world. At the heart of all of these issues are health policy and regulation. Research, clinical trials, drugs, medical devices, and access to healthcare are all impacted by state, federal and even global health policies and regulations.

What Exactly is Regulatory Affairs and Health Policy?

Health policies and regulations are designed to address problems or changes that need to be made in order to preserve and protect the health of a community’s citizens. Health policies include:

  • Health-related decisions made by legislators that are codified in the statutory language enacted in laws.
  • Rules/regulations designed to implement legislation or to operate government and its various health-related programs.
  • Judicial decisions related to health (Longest, 1998).

Regulatory affairs in particular is central to ensuring patient safety in clinical settings and the safety and effectiveness of medication, medical devices and medical procedures. From research and development to clinical trials and premarket approvals to manufacturing, labeling and product advertising, regulatory affairs impact every phase of bringing new products, medications and practices to market safely and effectively.

“Regulatory Affairs and Health Policy is a global program, attracting students from countries with diverse healthcare systems and unique challenges interested in learning best practices to implement in their own countries.”

In the U.S., the debate over the Affordable Care Act (ACA) enacted under the Obama administration and ongoing issues with the Veterans Health Administration have brought health policy and regulations to the forefront and made it a topic of conversation for everyone from politicians and the media to everyday citizens. Around the world, the spread of infectious diseases, like the West African Ebola outbreak and the Zika virus, have highlighted challenges with the costs and availability of vaccines and other drugs. Dramatic advances in gene therapies and medical technology have raised many concerns among researchers, clinicians and the general population. All of these issues, and many other challenges facing communities around the world, can be addressed by health policy and regulation.

A Growing Need for Professionals Knowledgeable About Health Policy & Regulations

Most healthcare professionals enter the field with a desire to improve the quality of life for people, whether that’s through research or clinical work. Regardless of motivation, they rarely have training or experience with the organizational, economic or political issues that impact the work they do and the patients they serve. Yet, health policies and regulations are the most effective way to drive change that results in improved health outcomes, greater efficiencies and expanded access to care.

Educational institutions, like Massachusetts College of Pharmacy and Health Sciences (MCPHS), have identified the growing need for healthcare professionals who have the knowledge and skills to evaluate the impact different programs and policies have on the health of individuals and communities. In response, graduate degree and certificate programs are evolving to encompass the growing field of health policy and regulation, and prepare students to evaluate, shape and implement policies and regulations that affect the access, quality and cost of care and patient safety.

Responding to Trends in Healthcare

As an institution that is 100 percent focused on health sciences, MCPHS has long understood the role of regulation and policy in healthcare. However, as health policy has evolved, so has MCPHS’s Master of Science in Regulatory Affairs and Health Policy. Originally focused on drug regulatory affairs, the program focus has now expanded to include a much broader and more holistic approach to health policy and regulation. Students are exposed to the breadth of issues faced by practitioners in the field today, whether at a federal regulatory agency or a medical tech startup.

In addition to the MS in Regulatory Affairs and Health Policy, MCPHS offers a Graduate Certificate in Health Policy and a Graduate Certificate in Regulatory Affairs. Coursework in all of these programs is centered around analysis of current, real-world issues.

Offering Flexibility to Meet the Diverse Needs of Students

Regulatory Affairs and Health Policy is a global program, attracting students from countries with diverse healthcare systems and unique challenges interested in learning best practices to implement in their own countries. Those students working in the field already bring valuable knowledge and experiences to their courses that benefits everyone in the program. Pharmaceutical leaders like Novartis have teams from as far away as Hyderabad, India participating in online courses to help them enhance their knowledge. All of these students bring new perspectives and create exceptional learning opportunities.

“The Regulatory Affairs and Health Policy program is able to accommodate the unique needs of all of its participants by offering a choice of in-person or online courses, as well as full-time or part-time.”

The diversity of students isn’t limited to geographic location. Students from many backgrounds enter the program, from those with a desire to enter the healthcare field or gain a better understanding of health policy to senior professionals who want to enhance their knowledge or shift focus in their careers.

The Regulatory Affairs and Health Policy program is able to accommodate the unique needs of all of its participants by offering a choice of in-person or online courses, as well as full-time or part-time. Online students are just as engaged as students sitting in a classroom on campus. The faculty are skilled at crafting online courses that stimulate discussion and collaboration. Additionally, whether students are pursuing the Master’s degree or one of the certificates, the programs can be completed at students’ desired pace. MCPHS works with students in an effort to design a path through the program that meets their specific objectives and accommodates their scheduling needs. Many students working full time choose to take just one course per semester while others take multiple courses at once.

Be Part of the Solution

Regulatory affairs and health policy are important parts of national and global dialogue that impacts not only healthcare systems but also decisions about education, economic development, the environment, and much more. The demand for qualified, knowledgeable professionals is growing. A degree or certificate in regulatory affairs and health policy from MCPHS provides the knowledge and skills to take a leading position in healthcare, biotech and pharma industries or in government or global healthcare organizations. The field is wide-ranging and offers many opportunities for rewarding, challenging and well-compensated careers.

Learn more about the innovative Regulatory Affairs and Health Policy programs at MCPHS.

Longest, B.B. (1998). Health policy making in the United States (2nd ed.). Chicago: Health Administration Press.