Biopharmaceutical Manufacturing and Regulatory Affairs Certificate
的 Biopharmaceutical Manufacturing and Regulatory Affairs Certificate 在 药学院 at PG电子试玩平台 focuses on the complex regulations governing the development, 这些产品的制造和分销, preparing students for positions in biotechnology and sharpening the skills and knowledge of those already working in this field. 这个证书是药学院颁发的 regulatory affairs (RA) and quality assurance (QA) graduate program.
Ever since the first biopharmaceutical product (recombinant human insulin) was approved in 1982, products derived through biotechnology have provided medical advances that include therapeutic monoclonal antibodies, 癌症疫苗, 细胞因子, 反义技术, 干扰RNA和生长因子.
的 regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, 严谨且高度复杂. 这个五门课程的证书具有很强的监管重点, enabling students to become fluent 在 most current regulations and trends affecting the industry. Current pharmaceutical science methods used 在 discovery of biotechnology products are studied, 包括材料采购和测试要求. Technologies and unique considerations associated with the manufacturing and distribution of biotechnology products are discussed, along with including the regulatory requirements for sterilization processes.
的 biotechnology industry continues to offer new job opportunities 在 U.S. 和国外. 两个最大的美国.S. 生物技术的中心是波士顿和旧金山, 占50以上,000 jobs in pharmaceutical biotechnology discovery and development. Hundreds of small, startup biotechnology companies exist throughout the U.S.
All courses 在 Biopharmaceutical Manufacturing and Regulatory Affairs Certificate are offered online, allowing remote students to participate in this highly relevant program.
邮政局长的证书
Students have the option to complete a post-master’s curriculum in Biopharmaceutical Manufacturing and Regulatory Affairs. 申请这个15学分的课程, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in bio化学, 生物学, 化学, 物理或与健康相关的学科.