Clinical Development 401: Phase IV

  • Course Price: $150
  • BIO Member Price: $120
  • Course Run Time: 50 minutes
  • Course Level: Level 3 - Advanced
  • Completion Period: 2 week

Clinical Development 401: Phase surveys the ongoing post-approval clinical assessments required by regulatory agencies. Learn how drug risk management is accomplished through detecting, assessing and reporting adverse effects using real-world data.

Suggested Prerequisites

Clinical Development 101: General Principles
Clinical Development 201: Phase I
Clinical Development 301: Phase II/III

  1. Purpose of Phase IV studies.
  2. Key limitations of pre-market studies and why post-market studies are an important complement to Phase I-III studies.
  3. Role of regulatory safety information reporting programs including MedWatch in US and EudraVigilance in Europe.
  4. In-depth look at Real-World Data (RWD) and Real-World Evidence (RWE) and their impact on safety.
  5. Identification of important real-world data sources
Certificate Requirements
  • Pass course exam with a 70 percent
  • Complete the course evaluation
Section 1: Phase IV Studies
Explains the purpose of Phase IV studies and takes in-depth look at numerous study examples including long-term safety and pharmacoeconomic studies.
Section 2: Pharmacovigilance and Post-Marketing Safety Follow-Up
Explains important regulatory terms such as pharmacovigilance, safety signal, signal detection and signal analysis. The purpose of regulatory safety...More
Section 3: Real-World Evidence
Discusses how regulatory authorities, such as FDA, are increasingly using real-world evidence to improve regulatory decisions. Important sources of re...More
Final Quiz
Course Evaluation
Certificate Requirements
  • Pass course exam with a 70 percent
  • Complete the course evaluation
You have two weeks from time of purchase to complete any of the online courses. For example, if you purchase the course at 9 am on Saturday, the course will close at 9 am 14 days later.

You can pay an additional fee for an extension.

Our online courses are between 40 minutes and 85 minutes in length. We suggest allowing 20 minutes to take the end of the course quiz and 10 minutes for the course evaluation. 

Yes, each course has an accompanying pdf that contains all of the presented course information. You will be able to download the pdf once you have registered for the course. 

There are no refunds if you decide to not take the course once you have registered. 

The online courses are fully animated with a professional voice-over. Each course begin with an overview of what you will learn, the course itself, and then ends with a course quiz to assess your understanding.

You can repeat the course as often as you like within your two week run time.

You have two chances to pass the quiz. A passing score is 70% or higher. 

Each course is to be taken by one individual. If you would like to take our online courses as a group, please contact Stacey Hawkins at This email address is being protected from spambots. You need JavaScript enabled to view it. for pricing.

There are three requirements to receive your course certificate. 1. You must view the entire course. 2. You must pass the course quiz with a 70%. 3. You must complete the course evaluation. You can download and print your certificate from your dashboard.

Before moving on to the next section of our on-demand, online courses, all slides within a section must be viewed.

There is an easy way for you to see which slides you have completed and not completed in the course. Look at the menu on the left side of the course- the slides that have been seen are darkened and the slides that have not been seen are light. 


Certificate Requirements
  • Pass course exam with a 70 percent
  • Complete the course evaluation