Post on 22-Apr-2018
transcript
FDA/CDER & UF/POP Graduate Program In Pharmaceutical Outcomes & Policy The University of Florida (UF) College of Pharmacy (COP) is collaborating with the Food & Drug Administration’s Center for Drug Evaluation and Research (CDER) to recruit individuals to become research scientists trained in safety and regulatory decision‐making.
The FDA/CDER Graduate Program works in collaboration with the U.S. Public Health Service Commissioned Corps (USPHS). It offers graduate education to career‐minded healthcare professionals who are interested in research surrounding the safe, effective and cost‐effective use of medications.
The UF & FDA/CDER Partnership
The Program admits 20 graduates from the health or related sciences annually. Students enroll in the UF Master of Pharmacy in COP Research program with an FDA/CDER safety and regulatory focus. Alternatively, students can receive funding for 2 years training towards a PhD degree in Pharmaceutical Outcomes & Policy (POP) Research. Integrating didactic course work and projects, students get extensive experience in FDA regulatory science. Internships
and mentoring will be provided by affiliate faculty located at CDER.
Students admitted are located full‐time at the University of Florida, and receive tuition, housing allowance, and a salary with benefits during their training. The student must agree to work for FDA/CDER for two years for each year of paid tuition.
Candidates for the Scholarship Program must qualify for service as a USPHS Commissioned Corps officer, which include American citizenship, age ≤ 44, degree in health or related sciences from an accredited program, and licensure in at least one state (for health professionals).
The UF Pharmaceutical Outcomes & Policy Research Masters Program This program was created to meet the need for researchers trained to investigate safe, effective, and cost‐effective use of medications. The program offers a terminal masters degree. However, coursework is fully transferable to the Department’s Ph.D. program.
The MS degree provides the credentials to serve as entry‐ or mid‐level research associates in academic and clinical research units, pharmaceutical companies and contract research organizations, and government organizations. Typically, these individuals work under limited direction as part of a multi‐disciplinary research group. Examples of such positions include research associates, program managers, and health scientists. Successful graduates bring a strong skills set in research design and measurement, biostatistics, and clinical, regulatory, ethical, and socio‐economic aspects of drug development, utilization, and drug and patient safety.
Applicants are selected based on academic achievement and demonstrated interest in POP Research. Applicants must have over 500 points for each of the verbal and quantitative sections of the GRE and a GPA ≥ 3.0.
Core Curriculum Core courses establish the basic competencies in statistics, research methods, and POP content.
Pharmacy Healthcare Systems Federal Regulation of Drugs and Pharmacy Study Design in POP Research Measurement in Pharmacy Research Introduction to Pharmaceutical Outcomes and Policy Statistical Methods I‐III Data analysis and interpretation Critical appraisal of pharmacoeconomic studies POP seminars and journal club Mentored traineeship (FDA/CDER, pharmaceutical industry, contract research)1
1Traineeship is mandatory for FDA scholars program. For other students, internships are voluntary and can be planned during the summer semester.
The University of Florida College of Pharmacy
Program Specializations
The POP Research Master’s degree is divided into three specializations:
Pharmacoepidemiology
Focuses on observational research methods, large secondary database analyses, and pharmacovigilance to evaluate drug safety and effectiveness.
Prepares students to participate in research to examine the utilization and effects of drugs and related products or services in populations
apply observational research methods in phase IV studies (comparative effectiveness and drug safety)
This program will be of interest to clinicians who discover the need to conduct research but lack the formal training. Applicants with a non‐clinical but strong methodological background such as in epidemiology may choose this degree to specialize in the evaluation of pharmaceuticals. Students learn to measure phenomena such as drug utilization, its quality, and sequelae on patient morbidity or mortality on a population level. Specialty courses include:
Pharmacoepidemiology and Risk Management Introduction to Pharmacoepidemiology Pharmaceutical Products & Public Policy
Pharmacoeconomics
Focuses on the economic evaluation of medication and medical technology
Prepares students to participate in research to examine pharmaco‐economic and related health outcomes
the cost, utilization, and economic efficiency of pharmaceutical products, medical devices, and related services in the delivery of health care
The program introduces students to basic theoretical principles of pharmacoeconomic research. Students will learn to measure phenomena such as resource utilization, quality of life (health state utilities), and cost‐effectiveness and generate decision‐making statistics such cost‐effectiveness acceptability curves. This program is suited for individuals with a clinical or economic background and interest in research that can inform healthcare policy and payment decisions. Specialty courses include: Pharmacoeconomics & Health Technology Assessment Pharmaceutical Microeconomics Pharmaceutical Health Economics
Patient Safety and Medication Use
Focuses on quality in medication use, technical / scientific aspects in quality improvement and program evaluation
Prepares students to participate in conduct of quality improvement studies quality‐related assessments of behavior, policy, and health care services as they relate to delivery of and access to healthcare
Studies will evaluate the quality of medication use and systems, to determine barriers and root causes related to patient safety risks and medication errors, to identify or develop targeted interventions for these barriers and root causes. Graduates may participate in regulatory and public policy initiatives that affect the use of medications in society, and the evaluation of programs to prevent, detect and resolve medication errors and improve patient safety. Specialty courses include:
Patient Safety Program Evaluation Healthcare and Patient Safety Patient Responsibility in Healthcare
Applicants who may be interested in the POP Research Masters Program are:
Practicing clinicians with a desire to increase their involvement in research
Individuals working in research settings who wish to formalize and extend their training in order to advance their careers in these settings
Graduates in the health sciences who would like to explore a clinically‐oriented research career while maintaining their involvement in clinical care
Individuals with previous training in research (e.g., epidemiology) who would like to advance and focus their training on pharmaceutical research
Positions at the FDA/CDER center around drug approval, drug safety, and risk communication:
Clinical reviewer Safety evaluator Epidemiologist Project manager
For More information, please contact:
Pharmaco‐epidemiology
Pharmaco‐economics
Patient Safety
Almut G. Winterstein, PhD Greg Wood, RN, MSN, FNP Associate Professor CaptainUSPHS University of Florida FDA/CDER 3522736258 3017963639 almut@cop.ufl.edu william.wood@fda.hhs.hov