When: 16-18 September 2025
Where: TOPRA Office, 3rd Floor City Reach, 5 Greenwich Place View, London E14 9NN
This course is also available to attend in person.
Suitable for
This course is essential for:
- Delegates from the regulatory affairs industry who wish to develop their knowledge of advanced therapy and medicinal products;
- Delegates from allied industries who wish to have a comprehensive understanding of the subject;
- Students on the TOPRA MSc programme.
Note: this course is also Module 22 of the MSc Regulatory Affairs.
Course information
This course explores the complexities of ATMP development and examines the regulatory frameworks in the EU and UK, with comparisons to other major jurisdictions such as the US and Japan. Participants will consider classification, quality, clinical and non-clinical requirements, and the scientific principles that underpin these innovative therapies. Emphasis is placed on developing the ability to anticipate regulatory issues and formulate strategic advice to guide ATMPs through to market authorisation.
Benefits to delegates
Lecturers and workshops will cover:
- ATMP legislation, classification and certification
- The importance of having a clear classification early in the regulatory process and borderlines between different types of ATMPs
- Good manufacturing and good clinical practice
- Issues specifically relating to ATMPs
- Other relevant legislation that must be considered such as requirements for blood derivatives
- The unique quality considerations for ATMPs such as the definition and characterisation of the starting materials, comparability and key specification tests
- Clinical and non-clinical considerations including the challenges with animal and disease model selection, immunotoxicity, GMO risk assessments
- How drug-device combination products that incorporate ATMPs are handled
- Regulatory requirements for a range of different countries such as the US, EU, UK and Japan.
The use of case studies and workshops will assist in the achievement of these learning outcomes and enable delegates to contextualise their understanding and knowledge.
CPD: This course provides 15 CPD hours upon successful completion.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
You can view and download the programme here
Module Leader
Presenters
The expert presenters for this training course are:
- Jessica Alsiö, Regulatory CMC Associate Director - Cell and Gene Therapy, Novartis
- Sabine Ruehle, Director, Regulatory Affairs, Boyd Consultants
- Sean Russell, Managing Partner, PrimeRA Pharma Partners
- Florence Salmon, Global Head Regulatory Cell and Gene Therapies, Roche
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,900.00 + VAT* |
Standard Price
Non-member |
£2,375.00 + VAT* |
TOPRA MSc Students
|
£1,650.00 + VAT* |
*VAT, where applicable, is charged at the rate of 20%.
| Discounted training course registration fees |
| Event Registration Type |
Price (GBP) |
Government or academic rates
TOPRA Member
|
£1,425.00 + VAT* |
Government or academic rates
Non-member
|
£1,781.25 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£950.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£1,187.50 + VAT* |
Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
Please email meetings@topra.org for a discount code before making your booking.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.