This course is also available to take part in online.
When: 10 - 12 February 2026
Where: Nhow, Brusseler Strasse 1-3, 60327, Frankfurt, Germany
Start Day 1: 13:00 CET | End Day 3: 16:00 CET
CPD: 19 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Students of the TOPRA MSc programme
- Delegates from the regulatory affairs industry who wish to develop their knowledge of the requirements for a new active substance
- Delegates 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 global regulatory requirements for chemistry and pharmacy data supporting new active substances
- Prepare and assess quality documentation for Common Technical Document (CTD), Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug (IND) submissions
- Interpret and apply good manufacturing, validation and analytical principles to meet regulatory expectations
- Critically assess communications and data from regulatory authorities to inform compliant development strategies
Course overview
Understanding the quality aspects of pharmaceutical development is critical for regulatory success. This course equips regulatory affairs professionals with the knowledge to navigate the regulatory requirements for chemistry and pharmacy data. Participants will explore the preparation of quality documentation, including IMPDs, INDs and CTD modules and examine data expectations for manufacturing, validation, and specification of drug substances and products.
Through lectures, case studies and workshops, you will:
- Explore how chemistry and pharmacy data support each stage of drug development
- Examine dossier structures and formats used in the EU and U.S.
- Discuss modern approaches to analytical methods, validation and manufacturing requirements
- Review specification and quality control principles for drug substances and products
Course presenter
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 *19% 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 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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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.