Legal Considerations in Drug Development

Legal Considerations in Drug Development


Welcome to Lawshelf’s video-course on legal and ethical considerations in drug development. More than 4.7 million Americans work in the pharmaceutical industry and more than 16 million work in healthcare. This course looks at the landscape of how the drug development process is regulated and at some of those most important regulations. Drug development and marketing is, of course, the lifeblood of the pharmaceutical industry.

This is an intermediate-level course and it is recommended for people with some knowledge of rules that relate to drugs, healthcare or pharmaceuticals, but the course can be useful for people with no such background.

The course starts by laying out the process of drug testing and describing the governmental framework that regulates the industry. We also look at the details and impacts of the 21st Century Cures Act, passed in 2016.

Module 2 begins our discussion of promotion and marketing, the other major topic of our course. We’ll focus on the “Bad ad” program and the many federal regulations that seek to ensure that consumers are given only information that is useful and accurate.

Module 3 focuses on drug pricing, including abusive pricing and antitrust issues. We will look at case studies in this regard.

Our last 2 modules look at government steps to relax regulations for drugs that are urgently needed. We will look at the requirements and procedures for expediting drug approval and ways the government seeks to expand access to critical drugs.

We hope that this course will give healthcare workers an understanding of the regulatory world in which they operate and ideas of all of the things they must watch for, especially in marketing and making representations about drugs and healthcare services.

Best of luck and we welcome your feedback.

What is a video-course?

A LawShelf video-course is an in-depth series of presentations on a discreet legal topic. LawShelf video-courses focus on practical legal information and applications and are each designed to familiarize the viewer with a legal topic quickly and efficiently.

Who should take a video-course?

Our video courses are designed for professionals such as attorneys, paralegals, corporate officers and financial professionals, as well as laypeople looking to deepen their knowledge of particular areas of law. The courses allow you to acquire the specific knowledge and skills that you need without the expense and time commitment of going “back to school” for a degree. 

How do I learn?

Video courses are divided into 5 or 6 modules.  Each module contains a video lesson (usually about 15 minutes long) and a series of self-test questions that you can use to practice and make sure that you understand the material.

How do I complete a video-course?

To complete a video-course, you must pass a 10-question multiple-choice examination by scoring 70% or higher.  The questions on the exam are randomly selected from the self-test question sets for the various modules. You can retake an exam as many times as you need to, though you will not get the same questions each time since the questions are drawn from an exam bank.

How long will it take me to complete a video-course?

Between watching the modules, doing the self-test practice questions, reviewing the material and taking the final exam, we estimate that completing a video-course requires a time investment of 4-5 hours.  The courses are designed to get straight to the point. We’re cognizant that your time is valuable, and we condense the information you need to know to comprehensively cover a subject into as little time as practical.

Is there limit to how many video-courses I can take or complete?

No. A LawShelf subscription enables you to access any and all LawShelf content, including all video-courses. You can take courses as quickly or slowly as your time allows.

Do I receive any recognition for completing a video-course?

Once you complete the course by passing the final exam, you will be awarded a digital badge to display as evidence of your training and accomplishment.

How will a digital badge help me? 

Modern educational trends are moving away from traditional classroom-based course completion models and towards skills-based education. Employers today care more about skills than ever before. LawShelf digital badges conform to the Open Badge standard and are verifiable records of your skills that can easily be shared online.

How long do I retain access to the course materials?

You retain access the modules and take the final exam as long as you are a subscriber to LawShelf.

Legal and Ethical Considerations in Drug Development: Module 1 of 5

Promotion of Pharmaceutical Products: Module 2 of 5

Drug Pricing: Module 3 of 5

Exceptions to the Rule Part 1: Module 4 of 5

Expectations to the Rule Part 2: Module 5 of 5

Final Exam only needs to be taken by those seeking to earn the Digital Badge credentials for this course.