This course is also available to attend in-person.
When: 1-3 December 2026
Where: Online
Day 1 start time: 10:00 | Day 3 end time: 17:00 BST
CPD: 15 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Students of the TOPRA MSc programme
- Professional from the regulatory affairs industry who wish to develop their knowledge of the whole life-cycle of the product
- Individuals 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:
- Recognise the needs of marketing colleagues in commercialising products, including the development of new dosage forms, additional indications, and changes in legal status
- Demonstrate how patents, supplementary protection certificates, and other intellectual property tools can be leveraged to optimise a product’s market life, and understand the role of regulatory professionals in maintaining these advantages
- Evaluate regulatory strategies that balance compliance with commercial objectives, including the considerations of pricing and reimbursement committees, to maximise potential market benefits
- Understand the importance of the Summary of Product Characteristics (SmPC) as a means of communication with prescribers and as the basis for advertising and patient information
- Interpret international regulations and constraints on advertising and promotion of pharmaceuticals and over-the-counter (OTC) medicines
- Appreciate the responsibilities for maintaining an active product licence, with respect to risk management plans and the safety reporting of adverse drug reactions
- Differentiate between internal and external activities associated with issue management, including handling falsified medicines
Course overview
Translating a product from development to commercial success requires strategic regulatory oversight across the entire lifecycle. This course enables delegates to explore the regulatory frameworks and strategic decisions involved in bringing a product to market and maintaining its presence. Topics include brand shaping, lifecycle management, advertising compliance, intellectual property, and pricing strategies. Participants will develop the ability to critically assess regulatory approaches that support brand protection and commercial sustainability in dynamic 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.
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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.