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  • 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

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Sections

Section 013

Jan 21 to Feb 11

Type: Live Online

Instructor:

  • Natalie McClure

Cost: $1,100.00

See section 013 Details

Type Live Online

Days

Sa

Time

9:00AM to 5:00PM Pacific Time

Dates

Jan 21, 2023 to Feb 11, 2023

Location

Live Online

Schedule and Location

View Details

Instructional Hours

30.00

Location

Live Online

Delivery Options

Online

Available for Credit

2 semester units

Spring enrollment opens on October 17!

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

Instructional Types

Live Online
Live Online courses provide an interactive learning experience with scheduled synchronous online sessions held via Zoom video conferencing (Pacific Time). Learn more about the Live Online format.
Online, Start Anytime
Continuous enrollment course begins when you enroll. You have a minimum of 90 days and a maximum of 180 days to complete the course.
Online, Fixed Date
Enroll in this course by its start date and complete it by its specified end date. There are no live sessions, but plenty of opportunities to collaborate with your classmates and instructor.
Classroom
Take classes in-person at one of our buildings or partner locations.

English Language Proficiency Requirements

All of our courses are taught in English. If English is not your first language, please use the following test scores as guides in order to be successful:

  • TOEFL: 90
  • IELTS Academic Format: 7
  • DAAD: C1
  • TEM-4 or TEM-8: Level 70
  • Duolingo: 115

Note: You do not need to submit test scores.

Extension

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Berkeley, CA 94704-7000

extension@berkeley.edu

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The University of California, Berkeley, is accredited by the Western Association of Schools and Colleges (WASC). UC Berkeley Extension—like all other UC Berkeley schools, colleges and departments—is accredited by WASC through the University.

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Course Fee

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.

PB HLTH X401.9 - 013 - Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices

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