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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.

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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

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PB HLTH X401.9 - 007 - Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices

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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.

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