When: 6-8 September 2023
Where: TOPRA Office, 6th Floor, 3 Harbour Exchange, London, E14 9GE
Also available as a virtual course, please click here for the virtual registration option.
This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of advanced therapy medicinal products. Advanced therapy medicinal include cell, tissue and gene therapies. It will allow you to examine the regulatory requirements for advanced therapy medicinal products in the EU and compare this with other territories. It will consider the scientific principles underpinning the development and regulation of advanced therapy medicinal products and the complexities involved.
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 and how drug-device combination products that incorporate ATMPs are handled.
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.
Regulatory requirements for a range of different countries will be discussed 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 the students to contextualise their understanding and knowledge.
You can view and download an example programme based on previous courses here
- Shaun Stapleton - Vice President Regulatory Affairs and Pharmacovigilance, ReNeuron Ltd
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. In addition to the module leader(s) listed above, Previous speakers for this course include:
This course is suitable for
Students of the TOPRA MSc programme
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
- TOPRA MSc students: 1,500£ + VAT*
- Delegate: 1,700£ + VAT*
A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities or patient groups, and/or those in full time education. Price: 1,275£ + VAT*.
Please email us at email@example.com for a discount code before making your booking.
*VAT, if applicable, is charged at the rate of 20%.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.