The University of California, Irvine Extension will offer two free, online courses covering the development, production and regulation of pharmaceutical and medical devices as part of its OpenCourseWare (OCW) efforts. The two courses, Medical Quality Product Systems and Regulatory Requirements for Pharmaceuticals, are geared to promote understanding of the circumstances and regulations under which new medical technologies and pharmaceuticals are developed, and the processes used to ensure a safe, viable product.
The Medical Quality Product Systems course walks students through U.S. and European medical device quality systems and their commonalities and differences. By the end of the course, students should be able to identify global quality standards for all medical devices, and put into perspective the impact these quality systems play in the approval process.
The Regulatory Requirements for Pharmaceuticals course examines the drug development process to help students articulate industry requirements for clinical trials, good manufacturing practices, good laboratory practices, the proper labeling of medical products and the FDA’s submission requirements.
Though both classes are geared toward pharmaceutical and medical device professionals, they also provide consumers with valuable information on why drug development can be a protracted process; help them understand regulatory concerns and standards; and offer insights on the highly competitive international pharmaceutical industry.