Course Overview

Orphan drugs are vital for those people with rare diseases, and this is recognised by Regulators globally. By gaining orphan drug designation, pharmaceutical companies access various incentives to encourage therapeutic development. However, it is important the system is not misused and that you fully understand the regulatory requirements and roadmap.

This training course will provide you with a comprehensive understanding of the opportunities and challenges offered by orphan drug designation. Once completed, you will understand the regulations and whether they are applicable to your product. You will also have a good understanding of the application process and procedure to obtain orphan drug designation. You will examine strategic considerations to ensure the most efficient regulatory path for your product. Learn more about how we deliver live online training.

Download the Agenda

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

Key Learning Objectives

• Examine the orphan drug regulations in the EU, US and Japan
• Gain a deep understanding of the regulations; what they cover and why
• Discover if your drug can be considered an orphan drug under the current regulations
• Review multiple considerations for orphan drug designation and the awards this brings
• Examine the orphan drug designation process in the EU and US
• Get first-hand insights on how to get the best from orphan drug regulations
• Analyse the maintenance of an orphan drug designation in preparation for MAA/NDA

What is Included in a Short Live Online Course?

• Direct access to an expert trainer
• Interactive and engaging sessions
• Access to the Educo Life Sciences Training Portal
• Unlimited access to the recordings for 2 weeks after the session

Course Dates

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

13 March 2025

1-Day Live Online Training
Register at the top of the page.

29 October 2025

1-Day Live Online Training
Register at the top of the page.

Group Discount

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

• To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
• There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
• The full training course is delivered online.
• For live online courses – The dates and times of modules/sessions are subject to change.
• For live online courses – The module/session durations are approximate.

Frequently Asked Questions (FAQs)

This course is designed for professionals who need to learn more about the orphan drug designation process and is relevant for large organisations all the way to start-ups. The course is very much applicable to those involved in the regulatory roadmap of their products and include:

• Regulatory professionals (managers, executives)
• Senior management
• Project management