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  • Berkeley Global

Professional Program in Regulatory Affairs

Reiss Reid
is the associate director of pre-clinical biology at Stealth Mode Biotech.

Graduate, Professional Program in Regulatory Affairs
Read Reiss Reid's Story.

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.

Next Steps

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Free Information Sessions

  • Start Anytime Online Science Courses on Friday, June 9, 2023 offered Online

    Date: Friday, June 9, 2023

    Time: 1:00pm to 2:00pm (Pacific Time)

    Location: Online

    Start Anytime Online Science Courses

    Start Anytime Online courses are continuous enrollment, which means the course is open for enrollment at any time and starts at the time you register. You can work through course material at your own pace and will have ample opportunities for interaction with your instructors and other students.

    Date: Friday, June 9, 2023

    Time: 1:00pm to 2:00pm (Pacific Time)

    Location: Online

    calendarItemDropdowninfo1DropStart Anytime Online Science Courses20230609T1300Z20230609T1400ZOnline<p>Start Anytime Online courses are continuous enrollment, which means the course is open for enrollment at any time and starts at the time you register. You can work through course material at your own pace and will have ample opportunities for interaction with your instructors and other students.</p>
    Register for the Start Anytime Online Science Courses Information Session on Friday, June 9, 2023Online

All Info Sessions

Courses

Required Courses

Expand or collapse Required Courses
Minimum Required

5 Course(s)

Maximum Allowed

0 Course(s)

We recommend that you start with Principles of Regulatory Affairs, but you may take the courses in any order.

  • PB HLTH X401.9 Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices
    Units / CEUs

    2

    Status

    Not Available

  • PB HLTH X402.2 BLA/NDA/MAA Submissions and Commercialization
    Units / CEUs

    2

    Status

    Not Available

  • PB HLTH X402.1 Harmonization Across Worldwide Applications
    Units / CEUs

    1

    Status

    Not Available

  • PB HLTH X403.1 Post-Approval Activities
    Units / CEUs

    1

    Delivery Options

    Online

    Status

    Available

  • PB HLTH X404.8 IND/CTA Preparation, Submission and Agency Interfacing
    Units / CEUs

    2

    Delivery Options

    Online

    Status

    Available

Electives

Expand or collapse Electives
Minimum Required

2 Academic Unit(s)

Maximum Allowed

0 Academic Unit(s)

  • PB HLTH X475.7 Principles of Supply Chain and Manufacturing
    Units / CEUs

    1

    Delivery Options

    Online

    Status

    Available

  • MCELLBI X431 Principles of Product and Process Development
    Units / CEUs

    1

    Status

    Not Available

  • PB HLTH X401.6 Principles of Quality and Compliance
    Units / CEUs

    1

    Status

    Not Available

  • PB HLTH X401.1 CMC Regulatory Compliance for Pharmaceutical Products
    Units / CEUs

    2

    Status

    Not Available

Course of Related Interest

Expand or collapse Course of Related Interest
Minimum Required

0 Course(s)

Maximum Allowed

0 Course(s)

  • PB HLTH 1023 The Drug Development Process: An Intensive Seminar
    CEUs

    3.6

    Status

    Not Available

May 11 Online Event: Careers in Biosciences

Biotechnology is a major economic driver and companies are seeking skilled professionals who are interested in contributing to rapid innovation and growth.

Continue Reading this Post

Certificate and Program Policies

  • Substitutions and Waivers
  • Transfers
  • Financial Aid
  • Transcripts and Records

Contact Us

To contact the department office, email biotech_online@berkeley.edu.

Prerequisites

There are no prerequisites for the Professional Program in Regulatory Affairs, but a bachelor's degree is recommended.

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 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.

How to Register

By registering, you declare your intention to complete the curriculum. To register online for the Professional Program in Regulatory Affairs, complete these two steps:

  1. Submit the online registration, and complete your student account profile if you are a new student.
  2. Pay the nonrefundable registration fee through your shopping cart. Please allow 3–5 business days for the registration to appear in your student account.

Estimated Cost

Each course is priced individually, and you pay the course fee at the time of enrollment. The program has an estimated cost of $6,150 (not including course materials or registration fee). Course fees are subject to change.

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 biotech_online@berkeley.edu 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.

Videos

Networking and Career Growth in Biosciences and Biotechnology Panel

 

Interview With Instructor Peter Calcott

 

Online Information Session

 

Advisory Board

Peter Calcott, Ph.D.
President and CEO
Calcott Consulting

Ronald Carlson
Head of Quality
UCSF Drug Product Services Laboratory

Cynthia Cowgill, Ph.D.
Regulatory Affairs
Gilead Sciences

Anthony Davies, Ph.D.
Vice President
Geron Corporation

Frederic Ivtchenko, M.B.A.
Product and Technology Transfer Manager
GlaxoSmithKline

Loël McPhee, M.S., RAC
RQC Strategic Operations
Genentech
Founder/Director
Andiron Technologies Inc.

Chin-Wei Soo, DRSc, FRAPS
Global Regulatory Head: Combination Product, Device, Digital Health
Roche/Genetech Inc.

Liz Wool, BSN, CCRA, CMT
President,NCC ACRP
Board of Trustees, ACRP
Editorial Advisory Board,ACRP Monitor magazine
President and CEO, QD-Quality and Training Solutions Inc.

Linda Yang, Ph.D., M.B.A.,RAC, CQA
Associate Director, Regulatory Affairs
Norgine Pharmaceuticals

Extension

1995 University Ave., Suite 130

Berkeley, CA 94704-7000

extension@berkeley.edu

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