Clinical Development 401: Phase IV

  • Course Price: $150 USD
  • BIO Member Price: $120 USD
  • 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

Takeaways
  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
View Outline
Certificate Requirements
  • View entire course
  • Pass course exam with a 70 percent
Trailer
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
LinkedIn Certificate Demo
Certificate Requirements
  • View entire course
  • Pass course exam with a 70 percent
You have two weeks from the time you start accessing the course. For example, if you start accessing the course at 9 am on Saturday, the course will close at 9 am 14 days later. 

Our online classes 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 to complete the class evaluation. 

Yes, each course has an accompanying pdf that contains all of the presented course information. 

There are no refunds once you have purchased an online course. 

The online classes 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 class 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 only when all three of these items are completed. 

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. 

 

BIO member discounts are available for on-demand, online classes. To access the BIO member discount, use your company email address during the checkout process. The checkout system will automatically recognize your organization and apply the 20% discount to your purchase if your company is a member of BIO. If you use a private email address we are unable to provide you the BIO membership discount.

If your on-demand course expires, but you have not completed it, you can extend it for an additional 2 weeks for $25.

  • Log into your dashboard
  • Go to the on-demand course you want to extend
  • The "Course Extension" button brings you to the payment gateway
  • Please note: It will appear you are being asked to pay the full amount of $150, but a discount will be automatically given once you fill in all of your payment information. 

You have 90 days, from the day your course expires, to take advantage of this nominal extension fee. Once the 90 days are past, you will need to pay the full price to view the course again. 

  1. Once your online course starts click on “Resources” in the upper right-hand corner
  2. In the drop down menu find the link “Course Slides”
  3. Download and/or print 
Certificate Requirements
  • View entire course
  • Pass course exam with a 70 percent