This course is also available to attend in-person.
When: 19-21 May 2026
Where: Online
Day 1 start time: 09:00 GMT | Day 3 end time: 17:00 GMT
CPD: 15 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Students of the TOPRA MSc programme
- Regulatory affairs professionals who wish to develop their knowledge of abridged applications
and specialised products
- Professionals from allied industries who wish to have a comprehensive understanding of the subject
What you'll learn
By completing this course, you will be able to:
- Evaluate the legal and regulatory requirements for abridged applications and specialised products
- Identify and assess the chemical/pharmaceutical, non-clinical and clinical data needed to
support these submissions
- Apply regulatory strategies and processes to ensure compliance with relevant directives and documentation
- Critically analyse legal texts, regulatory guidance and scientific evidence to inform robust regulatory advice
Course overview
A thorough understanding of data requirements is essential when working with abridged applications and specialised products. This course enables regulatory affairs professionals to explore the diverse types of abridged application pathways and the supporting data needed for new dosage forms, indications, and unique product types. It also examines the regulatory strategies and legal considerations surrounding these submissions, helping participants to navigate requirements and confidently provide informed regulatory advice.
The course also considers how these principles apply across key product categories, including herbals, inhaled products, drug–device combinations, blood products, radiopharmaceuticals, and cosmetics, as well as opportunities for abridged approaches in global markets.
Course presenters
TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire.
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,750.00 + VAT* |
Standard Price
Non-member |
£2,450.00 + VAT* |
TOPRA MSc Students
|
£1,750.00 + VAT* |
Those working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets, and MSEs (Micro and Small Enterprises) can also access discounted rates by becoming a TOPRA member. For more information about the discounts available, please email meetings@topra.org before making your booking.
Important Notice On VAT
In compliance with regulations, a *20% VAT will be charged to attendees only where applicable. If you have a VAT number or if the company or organisation you are affiliated with has a VAT number or equivalent please ensure it is visible on your profile. If your VAT number is not visible on your profile, please email finance@topra.org to have it updated. If you do not have a VAT number, there is no action required — VAT will be applied accordingly during the registration process. Please observe that the VAT number needs to be valid.
Click here to check and validate your VAT number.
For EU countries; if you are unsure of the VAT number, click here to check and validate your VAT number.
Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.