Pharmaceutical Industry Drug Regulatory Affairs (DRA)

Empowering Professionals in the Pharmaceutical Industry: A Comprehensive Online Course in Drug Regulatory Affairs

4.52 (507 reviews)
Udemy
platform
English
language
Science
category
1,875
students
2.5 hours
content
Feb 2023
last update
$59.99
regular price

What you will learn

Overview of the drug development process

The role of regulatory agencies in drug development and approval

International guidelines and regulations for drug development and approval

The drug registration process in the United States (FDA)

The drug registration process in Europe (EMA)

The importance of good manufacturing practices (GMP)

The principles of pharmacovigilance and adverse event reporting

The regulation of medical devices and combination products

Regulatory strategies for different types of drugs (e.g. orphan drugs, biosimilars)

The impact of intellectual property on drug development and approval

The role of clinical trials in drug development

The regulatory aspects of marketing and advertising of drugs

The regulation of generics and biosimilars

The ethical considerations involved in drug regulation

The future direction of drug regulation and its potential impact on the pharmaceutical industry.

The process and requirements for submitting a new drug application (NDA) or investigational new drug application (IND)

The requirements for post-approval changes and supplements to a drug product

The process and requirements for conducting clinical trials in the US and abroad

The requirements for labeling and packaging of drugs

The role of regulatory agencies in inspections and enforcement

The role of regulatory agencies in risk management and pharmacovigilance

The process and requirements for fast track, breakthrough therapy, and orphan drug designations

The process and requirements for market exclusivity and data protection

The regulatory requirements for advertising and promotion of drugs

Description

This drug regulatory affairs course is designed for professionals in the pharmaceutical industry who want to gain a comprehensive understanding of the drug development process and the regulations that govern it. The course will begin with an introduction to drug regulatory affairs, including an overview of the drug development process and the role of regulatory agencies such as the FDA and EMA. Students will learn about the international guidelines and regulations that govern drug development and approval, and will gain a detailed understanding of the drug registration process in the United States, Europe, and other major markets.

The course will cover the various stages of drug development, from pre-clinical research to post-approval changes, and will provide an in-depth look at the role of regulatory agencies in the approval and marketing of drugs. Students will learn about the principles of good manufacturing practices (GMP) and pharmacovigilance, as well as the regulation of medical devices and combination products. They will also learn about regulatory strategies for different types of drugs, such as generic drugs, orphan drugs and biosimilars, and will gain an understanding of the impact of intellectual property on drug development and approval.

The course will include a detailed examination of the role of clinical trials in drug development, and will cover the regulatory aspects of marketing and advertising of drugs. Students will also learn about the changing regulatory landscape due to advances in technology, and the regulation of generics and biosimilars.

Additionally, the course will cover the process and requirements for submitting a new drug application (NDA) or investigational new drug application (IND), as well as the requirements for post-approval changes and supplements to a drug product. Students will also learn about the process and requirements for conducting clinical trials in the US and abroad, as well as the requirements for labeling and packaging of drugs. The course will also include a detailed examination of the process for filing and handling of citizen petitions, as well as the role of regulatory agencies in inspections and enforcement.

The course will also cover the process and requirements for fast track, breakthrough therapy, and orphan drug designations, as well as the process and requirements for market exclusivity and data protection, and the regulatory requirements for advertising and promotion of drugs. The course will be delivered online, allowing students to learn at their own pace and on their own schedule.

Throughout the course, students will have the opportunity to engage in interactive discussions, and case studies, allowing them to apply their knowledge to real-world scenarios. Upon successful completion of the course, students will have a deep understanding of the drug regulatory process and be prepared to navigate the complex regulations that govern the pharmaceutical industry.

In conclusion, upon completion of the course, students will have a deep understanding of the drug regulatory process, including the drug development process, the role of regulatory agencies, the process of drug registration, and the specialized drug categories and drug listings. They will also have a grasp of the good practices, such as good clinical practice, good laboratory practice, and good manufacturing practices and the regulation of medical devices. They will also be familiar with the changing regulatory landscape, the role of health technology assessment, patient advocacy groups, international trade agreements, and the ethical considerations involved in drug regulation. They will be able to work confidently in the field of drug regulatory affairs and have the knowledge and skills necessary to make informed decisions in their professional roles.

Content

Introduction to Drug Regulatory Affairs

Introduction to Drug Regulatory Affairs
Historical Overview of Regulatory Affairs
Phases of Drug Development

Documentation for the Drug Registration

Regulatory Documents
Application Review Process- US FDA
Application Review Process- EU: Types of submission procedures
Application Review Process- EU: Application submission and review procedure

Specialized Drug Categories and Drug Listings

Generic Drugs
Orphan Drugs
Orange Book
Purple Book
Green Book

Medical Devices

Medical Devices
Medical Devices Marketing Application
Medical Devices Review Process

Good Practices

Good Clinical Practice
Good Laboratory Practice- Introduction
Good Laboratory Practices - Principles Part 1
Good Laboratory Practices - Principles Part 2
Good Manufacturing Practices – Part 1
Good Manufacturing Practices – Part 2

Product Development Lifecycle

Product Development Lifecycle

Screenshots

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Reviews

David
February 10, 2023
I believe the course was a good one for me. There was anxiety about how much information you were expected to retain.
Reid
January 27, 2023
The training was amazing, and it was beyond my expectation. Got to understand the principles of regulatory affairs and understood the roles and responsibilities of a regulatory affairs professional while working in a practical setting. Thanks a lot.
Kylan
January 25, 2023
First of all I want to thank the instructor, She is a Very Awesome Teacher with excellent Teaching Skills. I was Zero in regulatory affairs But Now I am Bit Confident. Overall Course is Best. I am Fully Satisfied with Course. And now After this course, I am interested to learn more and more from this instructor.

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5074068
udemy ID
1/10/2023
course created date
1/29/2023
course indexed date
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