Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Workshop Summary (2012) / Chapter Skim
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4 Education and Training of a Regulatory Science Workforce
4 Education and Training of a Regulatory Science Workforce
Pages 31-42
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From page 31... ...
The workshop discussions on education and training sought to identify current gaps and specific opportunities, including collaborative approaches, to strengthen the education and training of a regulatory science workforce. The workshop also examined barriers to implementing education and training strategies and potential ways to overcome these barriers.
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AN OVERVIEW OF EXISTING TRAINING PROGRAMS1 Training Opportunities Within FDA FDA is the major locus of regulatory research and training in the United States, Peck observed. Peck noted that the so-called "Subpart E Regulation," passed by Congress in 1989, included a provision that gave FDA authority to conduct regulatory research: "At the discretion of the agency, FDA may undertake focused regulatory research on critical ratelimiting aspects of the preclinical, chemical/manufacturing, and clinical phases of drug development and evaluation."2 Regulatory research is an inherent component of FDA's activities, and the agency has contributed to the advancement of the drug development field through its work with sponsors to advance development and evalu ation of products more rapidly.
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From page 33... ...
.5 Specific training programs in regulatory research are rare, said Peck, though many universities have produced new methodologies and good scientists who have contributed to advances in regulatory science. These advances have come largely from pharmaceutical science departments at schools of pharmacy in the United States and Europe, clinical pharmacology research fellowships, clinical investigator fellowships, and some NIH programs (such as the year-long clinical pharmacology course that has a regulatory framework)
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From page 34... ...
To better identify their audience, the Department of Translational Research Education at the University of Pennsylvania Perelman School of Medicine surveyed the many constituencies that have a stake in regula tion and drug development. Meagher noted the following findings from the survey: • Geographic location should not limit opportunities for educational encounters or for training programs.
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From page 35... ...
Metrics would assess whether training increases the ability of the research workforce to meet the needs of the regulatory science initiative, whether the programs create a viable career structure, and whether the training improves the quality of research management. At the individual level, metrics can show if a program enables a student to demonstrate knowledge in core concepts and to apply that knowledge through completion of a mentored project designed to enhance the individual's professional abilities.
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From page 36... ...
The following four education and training programs currently receive IMI funding: the European Medicines Research Training Network, the European Modular Education and Training Programme in Safety Sci ences for Medicine, the European Programme of Pharmacovigilance and Pharmacoepidemiology, and the Pharmaceutical Medicine Training Programme (PharmaTrain)
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From page 37... ...
A mechanism for lifelong learning or continued professional development also exists. FELLOWSHIPS AND EXCHANGE PROGRAMS Fellowships and Exchange at FDA Leslie Wheelock, Director, Office of Scientific Professional Develop ment, Office of the Chief Scientist, FDA, described FDA's CFP.
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From page 38... ...
Each project is identified by the centers as being of critical importance to address a scientific regulatory issue. Wheelock noted that FDA promotes this program widely to academic institutions and trade organizations in recognition that the agency presents a nontraditional career path for scientists calling for broad promotion and efforts to increase understanding and familiarity with science careers at FDA.
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From page 39... ...
a senior staff fellowship track that recruits investigators to develop their own independent research, also with the opportunity after a 7-year period to be considered for permanent hiring as a senior investigator. These positions require that the fellows spend about half of their time engaged in regulatory review activities.
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From page 40... ...
This program identifies scientists from the NIH Clinical Center for placement in short-term rotations in FDA's Office of Clinical Pharmacology or the Office of New Drugs. The rotations last a minimum of 8 weeks and provide learning experiences focused on the issues that would enable fellows to file an IND application.
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From page 41... ...
Fellows are required to take courses in drug law, reviewer training, statistics, and clinical trial design. Depending on background and experience, fellows also take classes on risk assessment and risk management, good manufacturing practice and good laboratory practice, technical writing, presentation skills, IND regulations, and NDA regulations.
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