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  • Berkeley Global

Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices

PB HLTH X401.9

47392111

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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This course applies to the following programs:

Professional Program in Regulatory Affairs

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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

Note: You do not need to submit test scores.

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