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Regulatory Affairs: Master of Science at San Diego State University
Author(s) -
Sevier Ernest Dale
Publication year - 2010
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.24.1_supplement.72.2
Subject(s) - regulatory affairs , regulatory science , health care , business , engineering ethics , engineering management , political science , engineering , medicine , public administration , law , pathology
The program addresses the pharmaceutical, biotechnology and medical device industries' need for education in the FDA regulation of biomedical products, and incorporates strategies to provide the knowledge and the expertise to apply it to regulatory challenges in the development, testing and manufacture of biomedical products. Learning objectives: Interpret healthcare‐related laws, regulations, guidelines, and policies; Evaluate research and development processes for biomedical products from a FDA regulatory perspective; Identify areas of compliance with regulations and policies; Interpret FDA‐related laws and regulations; Identify responsibilities of the regulatory affairs professional that extend throughout the lifetime of products; Identify international healthcare regulations that apply to the planning of a biomedical development program; Utilize effective communication skills with organizational behavior and project and operations management principals within a project development team environment; and Summarize and explain requirements for FDA submissions to testing investigational drugs and medical devices.