This course is also available to attend in-person.
When: 15-16 September 2026
Where: Online
Day 1 start time: 09:00 | Day 2 end time: 16:45 BST
CPD: 14.5 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Less experienced regulatory professionals who require comprehensive information on CMC (Synthetic molecules)
- Experienced professionals who are newcomers to CMC (Synthetic molecules)
- Anyone who wishes to update their knowledge in CMC (Synthetic molecules)
What you'll learn
By completing this course, you will be able to:
- Understand the full requirements for Module 3 of the regulatory dossier, including substance and drug product data expectations
- Identify common pitfalls and learn practical strategies to avoid them
- Gain insights from Regulatory Authority speakers on “how to get it right the first time” and what makes a high-quality submission
- Engage with experts in the field and participate in discussions in a collaborative environment
Course overview
This course provides an update on the latest scientific and regulatory requirements for Chemistry, Manufacturing, and Controls (CMC) with a focus on synthetic molecules. Delegates will learn about common pitfalls, data expectations and best practices for preparing Module 3 of Marketing Authorisation Applications (MAA).
Course presenters
Course presenters will be announced in the near future.
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.
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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.