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
UC Berkeley Extension Home Page
      • 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
      • 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.

Loading...

Sections

Section 007

May 15, 2021 to May 23, 2021 Live Online

Course Fee(s)

Course Fee credit (2 units)

$1,100.00


Type Live Online

Access classroom-style interactive learning from anywhere in the world! Attend scheduled online sessions with your instructor and classmates in addition to completing your coursework.

Live Online format allows you to take classes from anywhere with an internet connection. Classroom sections will be taught in this format through Spring 2021. Learn more about this format.

Beginning August 15, 2020, you must have a Zoom account to participate.

Many schools are now accepting transfer credit for online coursework, including health and sciences programs. Check with your institution before enrolling.

Days

Sa, Su

Time

9:00AM to 5:00PM Pacific Time

Dates

May 15, 2021 to May 23, 2021

Schedule and Location

View Details

Instructional Hours

30.00

Delivery Options

Online

Available for Credit

2 semester units

Instructors

  • Natalie McClure

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

Prerequisites

College level biology, biochemistry, chemistry or engineering

UC Berkeley Extension UC Berkeley Extension Footer Logo

1995 University Ave., Suite 200

Berkeley, CA 94704-7000

extension@berkeley.edu

  • About Us
  • Administration
  • Contact Us
  • Gifts
  • Jobs

Copyright © UC Regents

Powered by Destiny One
Facebook Facebook Icon Twitter Twitter Icon LinkedIn LinkedIn Icon YouTube YouTube Icon Instagram Instagram Icon

Join us on WeChat!

Image of UC Berkeley Extension's 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 - 007 - Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices

Processing...

Online

Natalie McClure

Dr. Natalie McClure is a regulatory affairs consultant with extensive experience in drug development, regulatory affairs and quality assurance.  She has filed more than 50 INDs, and CTAs and supervised regulatory affairs and clinical research for clinical trials in the US, Canada, Western Europe, Eastern Europe, Russia, India, and China. Natalie has directed drug development programs for new chemical entities and controlled release dosage forms. 

Dr. McClure obtained her PhD in Organic Chemistry from Stanford University and BS in Chemistry from the University of Michigan and then spent 10 years working for Syntex Research working in the process development laboratories on new synthetic approaches to prostaglandins and large scale peptide synthesis. Over the past 30 years, Natalie has worked with multiple small companies to establish their internal regulatory affairs and quality assurance systems.

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 http://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.