Professional Program in Regulatory Affairs offered by UC Berkeley
- Public University
1200 acre campus- Estd. 1868
Professional Program in Regulatory Affairs at UC Berkeley Overview
Professional Program in Regulatory Affairs
at UC Berkeley
Gain a comprehensive overview of the regulatory affairs principles and concepts
Duration | 36 months |
Total fee | ₹6,150 |
Mode of learning | Online |
Official Website | Go to Website  |
Course Level | UG Certificate |
Professional Program in Regulatory Affairs at UC Berkeley Highlights
Professional Program in Regulatory Affairs
at UC Berkeley
- Earn a certificate of completion from University of California, Berkeley
Professional Program in Regulatory Affairs at UC Berkeley Course details
Professional Program in Regulatory Affairs
at UC Berkeley
Skills you will learn
What are the course deliverables?
- Harmonization Across Worldwide Applications
- BLA/NDA/MAA Submissions and Commercialization
- Principles of Supply Chain and Manufacturing
- Principles of Quality and Compliance
More about this course
- 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
Professional Program in Regulatory Affairs at UC Berkeley Curriculum
Professional Program in Regulatory Affairs
at UC Berkeley
Required Courses
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
Professional Program in Regulatory Affairs at UC Berkeley Faculty details
Professional Program in Regulatory Affairs
at UC Berkeley
Elissa Carney, Program Director
Professional Program in Regulatory Affairs at UC Berkeley Entry Requirements
Professional Program in Regulatory Affairs
at UC Berkeley
Eligibility criteria
- Education: Bachelor's degree
Conditional Offer
- Yes
- Read moreEvery offer of admission is conditional. All admitted students have conditions that must be met in order to sustain Berkeley’s offer of admission. When accepting the offer, every admitted student is prompted to read and accept each of their conditions. they can find a printable version of their Conditions of Admission in the MAP@Berkeley portal, along with a printable version of your admission letter. Each condition check box must be selected. The student must then click Continue in order to progress to the admission deposit payment screen
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Professional Program in Regulatory Affairs at UC Berkeley Contact Information
Professional Program in Regulatory Affairs
at UC Berkeley