US Regulatory Strategy for Biologics & Pharmaceutical Drugs

US Regulatory Strategy for Biologics & Pharmaceutical Drugs, available at $54.99, has an average rating of 4.65, with 22 lectures, based on 147 reviews, and has 466 subscribers.

You will learn about 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 This course is ideal for individuals who are Scientists, physicians, and life science entrepreneurs who want to bring a biologic or drug to the US market or Regulatory Affairs professionals who want to improve their US regulatory knowledge for biopharmaceuticals or Biopharmaceutical industry analysts and consultants who want to better understand drug development for investment and business purposes or Students interested in a regulatory affairs career in the biopharmaceutical industry It is particularly useful for Scientists, physicians, and life science entrepreneurs who want to bring a biologic or drug to the US market or Regulatory Affairs professionals who want to improve their US regulatory knowledge for biopharmaceuticals or Biopharmaceutical industry analysts and consultants who want to better understand drug development for investment and business purposes or Students interested in a regulatory affairs career in the biopharmaceutical industry.

Enroll now: US Regulatory Strategy for Biologics & Pharmaceutical Drugs

Summary

Title: US Regulatory Strategy for Biologics & Pharmaceutical Drugs

Price: $54.99

Average Rating: 4.65

Number of Lectures: 22

Number of Published Lectures: 22

Number of Curriculum Items: 22

Number of Published Curriculum Objects: 22

Original Price: $39.99

Quality Status: approved

Status: Live

What You Will 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

Who Should Attend

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

Target Audiences

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

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.

Course Curriculum

Chapter 1: Section 1: Welcome & Introduction

Lecture 1: Welcome

Lecture 2: Drug Development Overview

Lecture 3: FDA History and Organizational Structure

Lecture 4: The Regulatory Affairs Professional in the Biopharma Industry

Lecture 5: Lecture 5: Section 1 Summary

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

Lecture 1: Introduction to the Course Drug

Lecture 2: Basics of Regulatory Intelligence and Developing a Strategy

Lecture 3: Planning Nonclinical Studies with the Investigational New Drug

Lecture 4: Manufacturing Considerations for the Investigational New Drug

Lecture 5: Preparing the IND for FDA Submission

Lecture 6: Section 2 Summary

Chapter 3: Section 3: Investigational New Drug (IND) – Clinical Development

Lecture 1: Is It Safe-to-Proceed?

Lecture 2: Clinical Development Strategy: Regulatory Paths & Programs

Lecture 3: IND Management

Lecture 4: Phase 1 & EOP1: Clinical Pharmacology

Lecture 5: Phase 2 & EOP2: Proof-of-Concept and Pediatrics

Lecture 6: Phase 3: Pivotal and Confirmatory Studies

Lecture 7: Section 3 Summary

Chapter 4: Section 4: New Drug Application – Getting A Drug Approved

Lecture 1: Preparing the NDA/BLA for FDA Submission

Lecture 2: The NDA/BLA Review Process and Getting FDA Approved

Chapter 5: Section 5: Post-Approval – Marketed Drug

Lecture 1: Post-Marketing Maintenance & Label Expansion

Chapter 6: Section 6: Course Wrap-Up

Lecture 1: Course Wrap-Up

Instructors

Brandon .
Regulatory Biotech Strategist

Rating Distribution

1 stars: 2 votes
2 stars: 2 votes
3 stars: 14 votes
4 stars: 47 votes
5 stars: 82 votes

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