US Regulatory Strategy for Biologics & Pharmaceutical Drugs
4.3 (6 ratings)
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US Regulatory Strategy for Biologics & Pharmaceutical Drugs

Learn how to navigate the US FDA regulations for getting your drug from bench to bedside.
4.3 (6 ratings)
Instead of using a simple lifetime average, Udemy calculates a course's star rating by considering a number of different factors such as the number of ratings, the age of ratings, and the likelihood of fraudulent ratings.
19 students enrolled
Created by Brandon Too
Last updated 1/2017
English
Current price: $25 Original price: $100 Discount: 75% off
5 hours left at this price!
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Includes:
  • 3 hours on-demand video
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion
What Will I Learn?
  • Navigate through the US FDA regulations for drug research and development
  • Conduct primary and secondary research to develop a regulatory strategy
  • Understand the role of a Regulatory Affairs professional in drug development
View Curriculum
Requirements
  • A background in medical science and/or the biopharmaceutical industry is helpful but not required.
  • A curiosity in understanding how the drug development process works.
Description

Understanding, navigating, and complying with the United States Food & Drug Administration (FDA)'s regulations is vital to translating medical discoveries from "bench to bedside". In this course, we will explore why regulations are important for public health, how to navigate through the FDA regulations to market a biologic or pharmaceutical, and practice developing a regulatory strategy.

At the end of this course, we will understand the drug development process and learn the key regulatory steps toward FDA approval. With this knowledge, we will also develop our ability to conduct regulatory intelligence and develop a regulatory strategic plan.

Scientists, physicians, entrepreneurs, public health professionals, industry analysts, consultants, and biomedical students interested in the biotechnology and pharmaceutical industry may find this course valuable.

Who is the target audience?
  • Scientists, physicians, and life science entrepreneurs who want to bring a biologic or drug to the US market
  • Regulatory Affairs professionals who want to improve their US regulatory knowledge for biopharmaceuticals
  • Biopharmaceutical industry analysts and consultants who want to better understand drug development for investment and business purposes
  • Students interested in a regulatory affairs career in the biopharmaceutical industry
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Curriculum For This Course
22 Lectures
02:58:02
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Section 1: Welcome & Introduction
5 Lectures 40:45

A brief lecture introducing the instructor and his motivation behind creating this course.

Preview 03:37

This lecture a student will gain a high-level overview of the drug development process, the trend in acute to chronic diseases, and the different industry stakeholders.

Preview 13:01

We will learn the history and organizational structure of the US Food and Drug Administration (FDA) relevant to drug development.

Preview 11:26

In this lecture, we will cover the role of a Regulatory Affairs Professional in drug development, their responsibilities, and their backgrounds.

Preview 09:54

A brief summary highlighting key lessons learnt in Section 1.

Preview 02:47
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Section 2: Pre-Investigational New Drug (Pre-IND) - Preclinical Development
6 Lectures 45:48

In this course, we will shepherd a fictional drug through the drug development process. This lecture will introduce us to this drug and our team.

Introduction to the Course Drug
02:10

An important key in developing a strategy is to be informed through gathering data and producing actionable intelligence. This lecture will introduce us to the common primary and secondary sources of information used to produce a regulatory strategy.

Basics of Regulatory Intelligence and Developing a Strategy
11:58

This lecture will review the nonclinical information needed to file an Investigational New Drug (IND) to the FDA.

Planning Nonclinical Studies with the Investigational New Drug
08:57

To develop and commercialize a drug, a team needs to consider the manufacturing components to assure that the drug is of high quality.

Manufacturing Considerations for the Investigational New Drug
05:36

In this lecture, we will review the necessary information needed to file an original IND to the FDA.

Preparing the IND for FDA Submission
13:33

This lecture will summarize the key points made in Section 2 toward preparing an IND submission to the FDA.

Section 2 Summary
03:34
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Section 3: Investigational New Drug (IND) - Clinical Development
7 Lectures 59:03

After IND submission, what happens next? In this lecture, we will review the key interactions between the FDA and applicant immediately after IND submission.

Is It Safe-to-Proceed?
03:53

Regulatory strategy begins before IND filing yet managing and adapting this strategy continues during clinical development. In this lecture, we will learn more about creating a regulatory strategy before and during clinical development.

Clinical Development Strategy: Regulatory Paths & Programs
19:31

This lecture will cover the basic IND management activities of a Regulatory Affairs professional.

IND Management
08:25

Clinical development is broken down into three distinct phases. This lecture we will review the Phase 1 aspects.

Phase 1 & EOP1: Clinical Pharmacology
08:52

Clinical development is broken down into three distinct phases. This lecture we will review the Phase 2 aspects and key regulatory milestones.

Phase 2 & EOP2: Proof-of-Concept and Pediatrics
09:54

Clinical development is broken down into three distinct phases. This lecture we will review the Phase 3 aspects.

Phase 3: Pivotal and Confirmatory Studies
04:03

This summary lecture will highlight the key points made in Section 3.

Section 3 Summary
04:25
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Section 4: New Drug Application - Getting A Drug Approved
2 Lectures 19:19

After clinical development has completed, preparing the NDA or BLA requires a cross-functional team to provide all the information in a structured method. We will learn the structure and content of the NDA.

Preparing the NDA/BLA for FDA Submission
08:21

Once the NDA or BLA is submitted to the FDA, there is a lengthy review process involving both the applicant and FDA. We will learn what this process entails.

The NDA/BLA Review Process and Getting FDA Approved
10:58
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Section 5: Post-Approval - Marketed Drug
1 Lecture 08:35

After a drug or biologic is FDA approved, what happens next? In this lecture we will understand the post-marketing activities.

Post-Marketing Maintenance & Label Expansion
08:35
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Section 6: Course Wrap-Up
1 Lecture 04:32

We will wrap-up this course with the instructor's final thoughts and an optional project.

Course Wrap-Up
04:32
About the Instructor
Brandon Too
4.3 Average rating
6 Reviews
19 Students
1 Course
Health Professional

The overarching mission is to empower others to improve health through individual- and population-based solutions.

Brandon has a broad background in health from exercise, nutrition, rehabilitation, medicine, and public health. Currently, he serves as a Regulatory Affairs professional for a biopharmaceutical company developing innovative drugs for significant unmet medical need. He has experience in clinical research and regulatory affairs and hopes to provide students his insight into developing novel medical products. He also enjoys providing personal training, nutrition advice, and coaching to reduce the risk of chronic diseases and to improve athletic performance.

Brandon graduated with both a MS in Exercise Science and BS in Exercise Biology from the University of California, Davis. He received the US Regulatory Affairs Certificate (RAC) from the Regulatory Affairs Professional Society (RAPS).