Newswise — NEWARK, NJ—The University of Medicine and Dentistry of New Jersey–School of Health Related Professions (UMDNJ-SHRP) has announced a new online Masters degree program in Clinical Trial Sciences—Drug Safety & Pharmacovigilance, the only such degree offered in New Jersey and one of just a few across the nation training professionals in this growing health field. It is also offering a Drug Safety & Pharmacovigilance certificate program. Both will be offered in collaboration with the University of Montreal. Enrollment is open now (http://shrp.umdnj.edu/dept/biopharma).
Due to recent government initiatives, training in pharmacovigilance and reporting of adverse reactions to drugs is a rapidly growing need, which promises employment opportunities.
“Consider the drug recalls you hear about,” says Barbara Gladson, PhD, who is director of the MS in Clinical Trial Sciences. “There is a new regulatory environment related to reporting adverse events as well as new quantitative methods for signal detection both during the clinical phase of drug development and also during the post-marketing period.”
Gladson notes that both the U.S. Food and Drug Administration [FDA] and the European Medicines Agency [EMA] have developed offices of drug safety and surveillance. The FDA has promoted these activities under a new discipline entitled “Regulatory Science Initiative” and defined as the “science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.”
There are numerous other related initiatives that are either current or in developmental stages, she adds.
“This area of science is important because we currently do not have a good way to detect adverse drug reactions [ADRs] once a product is released on the market,” says Gladson. “And during the drug development stages, most of the protocols are written to look at efficacy and not harm. These protocols would be structured differently if they could detect the ADR early on in the process.”
Details on Online MS Degree in Clinical Trial Sciences: Drug Safety & Pharmacovigilance The Drug Safety & Pharmacovigilance Track will be a 36-credit Master of Science degree consisting of a 9-credit core and 27 credits of specialization courses and electives, which include Regulatory Affairs, Clinical Trial Informatics and Clinical Trial Management & Recruitment Sciences. The overall goal of this degree is to prepare competent individuals to work in the biopharmaceutical industries, regulatory agencies, clinical research organizations, or academia, with the primary objective of assisting with the execution of clinical drug and device studies. The goals for this track are to educate students to recognize, quantify, analyze, and communicate the benefits and risks associated with drug and related products.
Details on the Certificate in Drug Safety & Pharmacovigilance The Certificate in Drug Safety and Pharmacovigilance is a 15-credit program. It has a similar goal as the degree track but is geared toward students currently working within the profession or students who wish to pursue work on the regulatory aspects of pharmacovigilance.
About the University of Medicine and Dentistry of New JerseyThe University of Medicine and Dentistry of New Jersey (UMDNJ) is New Jersey’s only health sciences university with more than 6,000 students on five campuses attending three medical schools, the State’s only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and New Jersey’s only school of public health. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, which provides a continuum of healthcare services with multiple locations throughout the State.
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