US Regulatory Strategy for Biologics & Pharmaceutical Drugs

Name: US Regulatory Strategy for Biologics & Pharmaceutical Drugs
Rating: 4.5 (178 reviews)

Learn how to navigate the US FDA regulations for getting your drug from bench to bedside.

Created byBrandon .

Last updated 1/2017

English

What you'll 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

Course content

6 sections • 22 lectures • 2h 58m total length

Welcome3:37
A brief lecture introducing the instructor and his motivation behind creating this course.
Drug Development Overview13:01
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.
FDA History and Organizational Structure11:26
We will learn the history and organizational structure of the US Food and Drug Administration (FDA) relevant to drug development.
The Regulatory Affairs Professional in the Biopharma Industry9:54
In this lecture, we will cover the role of a Regulatory Affairs Professional in drug development, their responsibilities, and their backgrounds.
Lecture 5: Section 1 Summary2:47
A brief summary highlighting key lessons learnt in Section 1.

Introduction to the Course Drug2:10
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.
Basics of Regulatory Intelligence and Developing a Strategy11:58
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.
Planning Nonclinical Studies with the Investigational New Drug8:57
This lecture will review the nonclinical information needed to file an Investigational New Drug (IND) to the FDA.
Manufacturing Considerations for the Investigational New Drug5:36
To develop and commercialize a drug, a team needs to consider the manufacturing components to assure that the drug is of high quality.
Preparing the IND for FDA Submission13:33
In this lecture, we will review the necessary information needed to file an original IND to the FDA.
Section 2 Summary3:34
This lecture will summarize the key points made in Section 2 toward preparing an IND submission to the FDA.

Is It Safe-to-Proceed?3:53
After IND submission, what happens next? In this lecture, we will review the key interactions between the FDA and applicant immediately after IND submission.
Clinical Development Strategy: Regulatory Paths & Programs19:31
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.
IND Management8:25
This lecture will cover the basic IND management activities of a Regulatory Affairs professional.
Phase 1 & EOP1: Clinical Pharmacology8:52
Clinical development is broken down into three distinct phases. This lecture we will review the Phase 1 aspects.
Phase 2 & EOP2: Proof-of-Concept and Pediatrics9:54
Clinical development is broken down into three distinct phases. This lecture we will review the Phase 2 aspects and key regulatory milestones.
Phase 3: Pivotal and Confirmatory Studies4:03
Clinical development is broken down into three distinct phases. This lecture we will review the Phase 3 aspects.
Section 3 Summary4:25
This summary lecture will highlight the key points made in Section 3.

Preparing the NDA/BLA for FDA Submission8:21
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.
The NDA/BLA Review Process and Getting FDA Approved10:58
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.

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 this course is for:

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

US Regulatory Strategy for Biologics & Pharmaceutical Drugs

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Course content

Section 1: Welcome & Introduction5 lectures • 41min

Section 2: Pre-Investigational New Drug (Pre-IND) - Preclinical Development6 lectures • 46min

Section 3: Investigational New Drug (IND) - Clinical Development7 lectures • 59min

Section 4: New Drug Application - Getting A Drug Approved2 lectures • 19min

Section 5: Post-Approval - Marketed Drug1 lecture • 9min

Section 6: Course Wrap-Up1 lecture • 5min

Requirements

Description

Who this course is for: