The Regulatory Process provides a summary of the regulatory bodies involved in approving pharmaceuticals, (both small molecules and biologics) discusses the application process involved in moving a product into clinical trials, introduces the Prescription Drug User Fee Act (PDUFA), explains the ways in which product approvals can be expedited, and finally discusses the application involved having a product approved, allowing for marketing and sale of the product.
02 The Regulatory Process Course
Section 2: IND/CTA Filing
Section 3: User Fee Programs
Section 4: Orphan Drugs and Expedited Pathways
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.
There are no refunds once you have registered for 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.
There are three requirements to receive your course certificate.
- You must view the entire course.
- You must pass the course quiz with a 70%.
- 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.
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 course has expired, but you have not completed it, you can extend it for an additional 2 weeks for $25.
- Log into your account
- Go to the course page you would like to extend
- Click on the "course extension" button. This will bring 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 up until 90 days from the day your course expired to take advantage of this discounted fee. Once the 90 days are past, you will need to pay the full price to view the course again.
- When you launch your online course (any section) look at the upper right-hand corner of the screen and click on “Resources”.
- A drop down box will appear that says “Course Slides”
- Click on "Course Slides". You can then download and/or print the slides.