Professional Program in Regulatory Affairs

Regulatory affairs personnel are the first-line assurance that company products and documentation are in accordance with regulatory bodies worldwide. The Professional Program in Regulatory Affairs reviews FDA regulations and other guidelines, Good Pharmaceutical Practice (GXP) principles, and ethical considerations covering the development of drugs and dossiers for clinical trials and licensure, and provides the training to manage these activities.

Additional coursework draws from the related functional areas of clinical research, product and process development, manufacturing and supply chain, and quality and compliance. Many required courses apply to multiple programs, allowing you to earn credit while you find the curriculum that's right for you.

Curriculum Requirements

The curriculum comprises 5 required courses and a minimum of 2-semester units of electives for a total of 10 units (150 hours of instruction). Candidates must pay a nonrefundable specialized program of the study registration fee.

You must take all courses for a letter grade. To receive the Award of Completion, you must maintain an overall minimum 2.5-grade point average, with a grade of C or better in each course. All coursework must be completed within three years.

Certificate and Award Request

Once you have completed the program coursework, notify UC Berkeley Extension that you have completed the curriculum and request your Award of Completion. Send an email to [email protected] or call (510) 642-1062. After your records have been reviewed, verified, and approved (usually within two to three weeks), your Award of Completion will be mailed to you.

Courses

Required Courses

• We recommend that you start with Principles of Regulatory Affairs, but you may take the courses in any order.
• Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices
• BLA/NDA/MAA Submissions and Commercialization
• Harmonization Across Worldwide Applications
• Post-Approval Activities
• IND/CTA Preparation, Submission, and Agency Interfacing

Electives

• Principles of Supply Chain and Manufacturing
• Principles of Product and Process Development
• Principles of Quality and Compliance
• CMC Regulatory Compliance for Pharmaceutical Products

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