University of California, Berkeley - Extension
Professional Program in Regulatory Affairs
Berkeley, USA
Course
DURATION
LANGUAGES
English
PACE
Full time
APPLICATION DEADLINE
EARLIEST START DATE
TUITION FEES
USD 6,150
STUDY FORMAT
Distance Learning
Regulatory affairs personnel provide first-line assurance that company products and documentation comply with regulatory bodies worldwide. The program reviews FDA regulations and other guidelines, Good Pharmaceutical Practice (GXP) principles, and ethical considerations involved in the development of drugs and dossiers for clinical trials and licensure. It provides training in managing these activities and includes related coursework in clinical research, product and process development, manufacturing and supply chain, and quality and compliance. The curriculum consists of five required courses and at least two semester units of electives, for a total of 10 units and 150 hours of instruction. There are no prerequisites, although a bachelor's degree is recommended. All courses must be taken for a letter grade, with a minimum grade of C required in each course. All coursework must be completed within three years.
The curriculum comprises five required courses and a minimum of two semester units of electives, totaling 10 units and 150 hours of instruction. Courses may be taken in any order, although Principles of Regulatory Affairs is recommended as the starting point. Elective options include supply chain and manufacturing, product and process development, quality and compliance, and CMC regulatory compliance. All coursework must be completed within three years.
The program has an estimated cost of $6,150, excluding course materials and the registration fee. Each course is priced individually and paid at enrollment; course fees are subject to change. Candidates must also pay a nonrefundable specialized program of study registration fee.