When: 24-25 June 2025
Where: TOPRA 3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9NN
Start time day 1: 09:00 GMT |
End time day 2: 16:30 GMT
This course is also available to take part in online.
Suitable for
This course is designed for those:
- Regulatory professionals who are new to the world of GMOs or have previous experience they would like to build on
- Regulatory professionals who wish to hear about the latest developments related to GMO applications, submission requirements and dossier preparation
- Anybody involved in GM medicines drug development who wishes to avoid potential delays due to GMO requirements
Course information
This interactive training course covers theoretical requirements as well as practical case studies on strategy planning and dossier preparation for GMO applications for clinical development in Europe, the UK as well as global considerations.
Industry experts will provide insights, from and industry and agency perspective, into:
- Current legislative requirements for GMO risk assessments, ranging from clinical development to licensing in Europe and the UK
- Product types including gene and cell therapies, examples of which include genetically modified cells, viral vectors, gene edited products and vaccines
- Dossier requirements and options (including use of and experience with common application forms [CAFs] and Summary Notification Information Format [SNIF]
- Steps to perform an environmental risk assessment (ERA) and complete regulatory GMO application forms
- Global considerations for genetically modified products in regions such as North America and APAC
- Strategic planning around the specific regulatory intricacies of genetically modified products from country to site level and how to avoid common pitfalls
- How to establish internal company processes and navigate cross-functional planning for managing GMO requirements
Benefits to delegates
- Expand your knowledge on GMO regulatory frameworks
- Learn to understand the challenges involved in managing GM medicines and leverage efficient and consistent practical solutions to avoid potential delays in GM drug development
- Learn by doing – participate in case studies and interactive sessions on how to develop strategies and work on application dossiers for genetically modified products
- Empower participants to navigate the fast-paced evolution of the regulatory requirements and communicate the critical needs to internal and external stakeholders
- Meet and learn from experts in the field to build a network to support the rest of your career
CPD: This course provides 12 CPD hours on successful completion. To learn more about why continuing professional development is important, visit our Lifelong Learning page.
Programme
The draft programme is available here.
Module Leaders
This course has been developed by the TOPRA Biotech, Cell & Gene Therapies SPIN group. The presenters have proven track records of regulatory submissions supporting both clinical trials and marketing authorisations, and publications in the GMO space.
Presenters
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,050.00 + VAT* |
Standard Price
Non-member |
£1,250.00 + VAT* |
Save on the full cost of membership and £180 on the price of your training
course when you add TOPRA membership to your booking (membership fees are exempt from 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
|
£787.50 + VAT* |
Government or academic rates
Non-member
|
£937.50 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£525.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£625.00 + 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%.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.