US Regulatory Strategy for Biologics & Pharmaceutical Drugs

Course Feature

Cost

Paid
Provider

Udemy
Certificate

Paid Certification
Language

English
Start Date

2017-01-01
Learners

No Information
Duration

No Information
Instructor

Brandon Too

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4.8

361 Ratings

This course provides a comprehensive overview of US Food & Drug Administration (FDA) regulations for biologics and pharmaceutical drugs. It is beneficial for scientists, physicians, entrepreneurs, public health professionals, industry analysts, consultants, and biomedical students interested in the biotechnology and pharmaceutical industry. Learners will gain an understanding of the importance of FDA regulations for public health, and how to navigate through the FDA regulations to market a biologic or pharmaceutical. They will also develop their ability to conduct regulatory intelligence and develop a regulatory strategic plan. This course is a great opportunity to gain knowledge of the drug development process and the key regulatory steps toward FDA approval.

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US Regulatory Strategy for Biologics & Pharmaceutical Drugs

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Course Overview

❗The content presented here is sourced directly from Udemy platform. For comprehensive course details, including enrollment information, simply click on the 'Go to class' link on our website.

Updated in [July 27th, 2023]

This course provides learners with an understanding of the importance of US Food & Drug Administration (FDA) regulations for public health, and how to navigate through the FDA regulations to market a biologic or pharmaceutical. Participants will gain knowledge of the drug development process and the key regulatory steps toward FDA approval, as well as develop their ability to conduct regulatory intelligence and develop a regulatory strategic plan. This course is beneficial for scientists, physicians, entrepreneurs, public health professionals, industry analysts, consultants, and biomedical students interested in the biotechnology and pharmaceutical industry.

Course Syllabus

Section 1: Welcome & Introduction

Section 2: Pre-Investigational New Drug (Pre-IND) - Preclinical Development

Section 3: Investigational New Drug (IND) - Clinical Development

Section 4: New Drug Application - Getting A Drug Approved

Section 5: Post-Approval - Marketed Drug

Section 6: Course Wrap-Up

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