医疗器械证书
的 医疗器械证书 in the 药学院 at 亿德体育 focuses on the domestic and global regulations governing the 医疗设备 field. Many pharmaceutical companies have separate device divisions or entire subsidiaries that focus on marketing medical and diagnostic devices, 如诊断仪器和工具包, 手术海绵, 以及给药装置, 从注射器到透皮贴剂. 这个证书是学校颁发的 regulatory affairs (RA) and quality assurance (QA) graduate program 可以在网上找到. 获得此证书不需要硕士学位.
Regulatory affairs professionals pursuing this certificate will deepen their understanding of the device field by exploring the similarities and differences in pharmaceutical and device regulations. 的 Food and Drug Administration’s (FDA) regulation of 医疗设备s has the same objective as its regulation of drugs: protecting public health by ensuring a balance of risk versus benefit for marketed products. 一些高风险医疗设备, 比如缝合线, 隐形眼镜和抗生素敏感盘, were regulated as drugs before the 1976 legislation was passed extending the FDA’s regulatory authority over devices. Because 医疗设备s are highly variable in complexity and technology, a more flexible approach to their regulation has evolved to meet this objective than has evolved for drugs.
的 医疗器械证书 reviews key aspects of the 医疗设备 industry: regulation, compliance and submissions in the domestic and global realms. Instructors are experts from the 医疗设备 sector who conduct highly interactive classes with hands-on workshops, enabling students to apply their knowledge immediately to the workplace.
邮政局长的证书
Students have the option to complete a post-master’s curriculum in 医疗设备s. Coursework focuses on the domestic and global regulations governing the 医疗设备 field. 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 biological sciences, 工程, 医疗保健, 自然科学或相关学科.