Build a solid foundation in practical applications of regulatory affairs and quality assurance informing the development and manufacture of biopharmaceutical products through coursework in both didactic and laboratory settings. Gain hands-on experience with the development, manufacturing, and analytical processes associated with the production of safe and efficacious treatment options to support this rapidly expanding field. Leverage the highly knowledgeable and industry-experienced staff and state-of-the-art equipment made available through this program offered in conjunction with the Jefferson Institute of Bioprocessing at Thomas Jefferson University.

Prepare to enter the pharmaceutical field by sharpening your knowledge of industry terminology and gaining familiarity with regulations and quality practices. The program is aimed at professionals without science backgrounds, including those coming from business and the liberal arts.

Temple’s Certificate in Biologics and Biosimilars Manufacturing focuses on chemistry, manufacturing and controls aspects in the development and manufacture of these products, preparing students for positions in the biopharmaceutical industry and sharpening the skills and knowledge of those already working in this field. In this five-course certificate program, which can be delivered remotely, students become fluent in the methods used in the discovery of biopharmaceutical products, including materials sourcing and testing requirements. Technologies and unique considerations associated with the manufacture of biopharmaceutical products are discussed.

Our specialized curriculum—which can be delivered remotely—delves into the requirements of the major International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use markets for biologics and biosimilar products. Students form a strong foundation in the biologics and biosimilar regulatory landscape. They learn the tools and information to understand how biologics and biosimilars are regulated nationally, regionally and globally. The courses also expose students to key trends and controversies facing the biologics and biosimilar industry.

Biopharmaceuticals have provided innovative medical advances including the development of cancer vaccines and therapeutic antibodies. This pre-master’s certificate program emphasizes the complex regulations governing the development, manufacturing and distribution of such biopharmaceutical products.

Gain the tools and information to design, conduct and audit clinical trials of pharmaceutical products with the Pre-Master’s Graduate Certificate in Clinical Trial Management. Cover topics including protocol development, volunteer informed consent, study management and the role and responsibilities of institutional review boards. The professional certificate is aimed at pharmaceutical and healthcare professionals who are interested or already participate in clinical trials.

Explore safe and effective design of innovative pharmaceutical products in this certificate program. Keep up with the rapidly changing landscape of pharmaceutical industry regulation at the local, national and global levels. You’ll learn fundamental concepts of regulation and quality assurance that determine the discovery and development of new drugs. Gain a comprehensive understanding of the latest trends and practices to foster professional success.

Learn best practices for regulations in the food industry and gain the tools to respond quickly to new regulatory and quality assurance trends and developments. Designed specifically for individuals working in Philadelphia’s large food industry, this pre-master’s certificate allows you to earn credentials and advance in this quickly growing field.

Explore regulatory issues that are unique to generic drug manufacturers as well as necessary for industry professionals to understand to help companies create safe and effective bioequivalent products. This specialized curriculum—which can be delivered remotely—delves into domestic and global regulations for generic products. Courses explore the drug development process, global marketplace for generic drugs and building a strong foundation in generic regulatory issues, including the ANDA process. Learn the key trends and controversies facing the generic industry as well as how generic drugs are manufactured and regulated nationally and globally.

Study the regulations of domestic and global clinical trials and pharmacovigilance activities in the pharmaceutical and related industries (biologics, consumer products,  devices and vaccines). Learn how to manage and assist in clinical trials and to review and interpret safety data of clinical trials or post-marketing reports of healthcare products, preparing you for a career path in regulated industry or government agencies.  This program is only open to students with PharmD degrees.

Focus on unpacking and understanding the domestic and global regulations that govern the medical device field. Work to protect public health by ensuring a proper balance of risk and benefit for marketed products. In this pre-master’s certificate program, you’ll learn flexible frameworks for dealing with medical devices that vary in complexity and technology. Review key aspects of the medical device industry, including compliance, regulation and submissions in the domestic and global markets.

Become an expert in proper labeling, advertising and promotions of pharmaceuticals and related products. Home in on differences in regulations among key world markets and prepare for a career in the industry. Coursework  in this pre-master’s certificate program will guide you through complex and continually evolving regulations for labeling and promotion, both within the U.S. and globally.

Trace the steps that make up the manufacturing process, and study process monitoring and controls. Enhance your scientific understanding of the manufacturing process while learning to set standards that will increase product quality, improve plant efficiency, lower product costs and meet international and national standards. Choose to take this pre-master’s certificate on its own or use it as a basis for launching your master’s degree in quality and regulatory assurance.

The Pharmaceutical Regulatory Sciences MS curriculum addresses pharmaceutical science and regulatory affairs (RA) and quality assurance (QA) courses for current professionals looking to advance in their fields. The pharmaceutical science component of the program focuses on the core science principles involved in the development and manufacturing of therapeutic products, while RA and QA courses provide a strong framework of regulations and quality practices. The program is available on a part-time basis and offered online on weeknights over three semesters a year. 

Master the academic, interpersonal and professional skills necessary for pharmacists. Participate in dynamic courses, group projects, lab work and diverse inter-professional clinical experiences. Temple offers elective concentrations, which allow you to tailor your studies in a specialization: Business, Clinical Practice, Clinical Trials, Medication Safety or Regulatory Affairs.

Gain the knowledge and skills needed for supervisory and managerial roles in the biosimilars, biotechnology, device, generics, pharmaceutical and related industries. Choose from more than 80 courses that are offered on weekends and in the evening, both on campus and online, in regulatory affairs and quality assurance.

Learn the process of setting up sterile environments to manufacture devices and drug products safely. Train to strategically design facilities and implement techniques, including microbial controls and sterile filtration during the manufacturing process in this pre-master’s certificate program.

Validation is a critical and all-encompassing tool in the pharmaceutical, medical device, biotechnology and related regulated industries. In quality assurance practices, validation includes every test and scientific methodology used to demonstrate that facilities, utilities, equipment, processes, computers and products meet agreed-upon standards. This five-course (15-credit) certificate program—which can be delivered remotely—is designed for professionals working in a regulated industry who need theoretical, practical and hands-on knowledge of various validation principles. Participants may also select three specialized electives in Validation Science that best meet their career needs.