This course is also available to attend online.
When: 17 - 18 February 2026
Location: TOPRA Office, 3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9NN, UK
Day 1: 09.00 - 16.45 GMT | Day 2: 09.00 - 17.00 GMT
CPD: 15 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Regulatory affairs professionals in the pharmaceutical industry writing reports and dossier sections
- Related technical experts who write regulatory documents
What you'll learn
By completing this course, you will be able to:
- Write clear, precise, and well-structured regulatory documents and communications
- Organise and build regulatory submission documents from data to final dossier
- Apply best practices in writing style, language, and clarity
- Manage teams, peers, and differing opinions effectively
- Write technical reports and overviews that communicate key messages clearly
- Understand what regulators look for, with practical tips from regulatory authorities
Course overview
This course provides a practical and theoretical foundation in writing effective
regulatory documents and communications. You will learn how to craft
clear, precise and impactful materials that support success in regulatory affairs.
Through interactive sessions, case studies, and guidance from industry experts, you will explore key topics such as good writing principles, document structure, dossier management, technical report writing, and communication strategies, both within teams and with regulatory authorities.
Designed by professionals for professionals, this course builds your skills and confidence to prepare high-quality submissions. It also helps you minimise regulator queries and strengthen your reputation for clear, precise work.
Course presenters
Course presenters will be announced shortly.
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,250.00 + VAT* |
Standard Price
Non-member |
£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 all attendees, regardless of your country of origin. 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.