This course is also available to attend in-person.
When: 17 - 19 November 2026
Where: Online
Day 1 start time: 13:30 GMT| Day 3 end time: 16:00 GMT
CPD: 15 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 strategic planning of nonclinical development
- 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:
- Develop a systematic understanding, and a critical awareness of the practical management aspects of nonclinical development, the types and design of nonclinical safety and pharmacokinetic studies and the regulatory requirements nonclinical drug development
- Demonstrate a comprehensive understanding of the nonclinical regulatory requirements, nonclinical guidelines and other requirements for running nonclinical drug safety studies
- Have a conceptual understanding of the legal and ethical regulatory aspects of nonclinical research and the importance of critical evaluation of the study designs and data generated during research on medicinal products
- Demonstrate the ability to critically analyse the nonclinical regulatory documentation and guidelines for the nonclinical part of drug development
- Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data and communicate your conclusions to the specialist and non-specialist audiences including working with other departments
- Critically appraise and evaluate communications from regulatory bodies and research publications covering nonclinical data
Course overview
The nonclinical regulatory requirements for drug development encompass modern approaches to candidate selection alongside the latest requirements for pharmacokinetics, toxicology, genotoxicity, carcinogenicity, and reproduction testing. The role of regulatory affairs extends throughout the nonclinical phase, from initial development through to filing and life-cycle management, with careful attention given to the nonclinical components of key regulatory documents and submissions such as the IB, IMPD, IND, NDA, MAA, and CTD reports. To support the achievement of these learning outcomes, case studies and workshops are used to help students consolidate and apply their understanding and knowledge.
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.