Skip to main content
The following fields are required:
Error has occurred. Please reload this page and try the operation again.
  • Agents
  • Partners
  • Student Login
  • Instructor Login
Extension
      • Areas of Study
        • Art and Design
        • Behavioral Health Sciences
        • Business
        • Construction and Sustainability
        • Education
        • Humanities and Languages
        • Sciences, Mathematics
          and Biotechnology
        • Technology and
          Information Management
        • Writing, Editing and
          Technical Communication
      • Online Learning
        • Online Courses and Certificates
      • Custom Programs
        • For Universities and Organizations
      • Events
        • Information Sessions
        • Free and Low Cost Events
      • Academic Services
        • Enrollment
        • Transcripts
        • General Information
        • Community Guides
      • Course and Program Information
        • Latest COVID-19 Information
        • Online Course Policies
        • Certificates, Programs and CEUs
        • Concurrent Enrollment
        • Career Services
      • Student Aid
        • Disabled Students
        • Financial Assistance
        • Community Impact Scholarship
      • Voices
        • Voices Home
        • Educator Insights
        • Student Stories
        • Professional Pathways
        • Industry Trends
      • Events
        • Information Sessions
        • Free and Low Cost Events
  • Berkeley Global

Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices

PB HLTH X401.9

47392111
Delivery Options Online

Learn about the regulatory authorities whose regulations and requirements must be met to ensure compliance with the laws governing the pharmaceutical and medical device industries. Examine the steps leading to testing products in humans, the approval of products, post-approval requirements and industry implementation.

Prerequisites:

College level biology, biochemistry, chemistry or engineering

Loading...

Sections

Section 008

Aug 21, 2021 to Sep 18, 2021 Live Online

Course Fee(s)

Course Fee credit (2 units)

$1,100.00

Type Lecture

Days

Sa

Time

9:00AM to 5:00PM Pacific Time

Dates

Aug 21, 2021 to Sep 18, 2021

Schedule and Location

View Details

Instructional Hours

30.00

Delivery Options

Online

Available for Credit

2 semester units

Instructors

  • Angela Bazigos

Section Notes

No Class on September 4th (Labor Day Holiday)

This course applies to the following programs:

Professional Program in Regulatory Affairs

Expand or collapse section

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

Learn More About this Program

Notes

Departmental contact: biotech_online@berkeley.edu | (510) 642-1062

English Language Proficiency Requirements

All of our courses are taught in English. For you to be successful, you should be able to demonstrate your English proficiency by speaking at the following testing levels:

  • TOEFL: 90
  • IELTS Academic Format: 7
  • DAAD: C1
  • TEM-4 or TEM-8: Level 70
  • iBT Special Home Edition and myBest scores are accepted. Scores must be from the past two years.
Extension

1995 University Ave., Suite 200

Berkeley, CA 94704-7000

extension@berkeley.edu

Copyright © UC Regents

Powered by Destiny One

Academic Areas

  • Art and Design
  • Behavioral Health Sciences
  • Business
  • Construction and Sustainability
  • Education
  • Humanities and Languages
  • Sciences, Mathematics and Biotechnology
  • Technology and Information Management
  • Writing, Editing and Technical Communication

Resources

  • Latest COVID-19 Information
  • About Us
  • Career Services
  • Administration
  • Transcripts
  • Gifts
  • Jobs
  • Contact Us
Facebook Facebook Icon Twitter Twitter Icon LinkedIn LinkedIn Icon YouTube YouTube Icon Instagram Instagram Icon
WeChat QR code

We use cookies to give you the best experience on our website. By clicking Accept, you consent to our cookie policy and privacy policy.

Session Time-Out

For security reasons and the protection of your personal information, your session will time out due to a period of inactivity in minute(s) and second(s). Click Extend My Session to continue. For security reasons and the protection of your personal information, your session timed out after a period of inactivity. You will be redirected to the home page.

Confirm

Alert

Course Fee

PB HLTH X401.9 - 008 - Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices

Processing...

Online

Angela Bazigos

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Drugs, Biologics, Medical Devices, Healthcare & Food. Experience combines GxP regulations in Quality Assurance, Regulatory Compliance, Clinical Trial Science, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers, Veracyte and other Medical Device Companies & Stanford Hospital. Former President of Pacific Regional Chapter of Society of Quality Assurance. 

Processing...

Privacy Policy

Cookie Policy

This statement explains how we use cookies on our website. For information about what types of personal information will be gathered when you visit the website, and how this information will be used, please see our privacy policy.

How we use cookies

All of our web pages use "cookies". A cookie is a small file of letters and numbers that we place on your computer or mobile device if you agree. These cookies allow us to distinguish you from other users of our website, which helps us to provide you with a good experience when you browse our website and enables us to improve our website.

Types of cookies we use

We use the following types of cookies:

  • Strictly necessary cookies- these are essential in to enable you to move around the websites and use their features. Without these cookies the services you have asked for, such as signing in to your account, cannot be provided.
  • Performance cookies- these cookies collect information about how visitors use a website, for instance which pages visitors go to most often. We use this information to improve our websites and to aid us in investigating problems raised by visitors. These cookies do not collect information that identifies a visitor.
  • Functionality cookies- these cookies allow the website to remember choices you make and provide more personal features. For instance, a functional cookie can be used to remember the items that you have placed in your shopping cart. The information these cookies collect may be anonymized and they cannot track your browsing activity on other websites.

Most web browsers allow some control of most cookies through the browser settings. To find out more about cookies, including how to see what cookies have been set and how to manage and delete them please visit https://www.allaboutcookies.org/.

Specific cookies we use

The list below identify the cookies we use and explain the purposes for which they are used. We may update the information contained in this section from time to time.

  • JSESSIONID: This cookie is used by the application server to identify a unique user's session.
  • registrarToken: This cookie is used to remember items that you have added to your shopping cart
  • locale: This cookie is used to remember your locale and language settings.
  • cookieconsent_status: This cookie is used to remember if you've already dismissed the cookie consent notice.
  • _ga_UA-########: These cookies are used to collect information about how visitors use our site. We use the information to compile reports and to help us improve the website. The cookies collect information in an anonymous form, including the number of visitors to the website, where visitors have come to the site from and the pages they visited. This anonymized visitor and browsing information is stored in Google Analytics.

Changes to our Cookie Statement

Any changes we may make to our Cookie Policy in the future will be posted on this page.