This course is also available to attend online.
When: 18 -19 May 2027
Where: TOPRA 3rd Floor, City Reach. 5-6 Greenwich View Place, London, E14 9NN
Day 1 start time: 09:00 | Day 2 end time: 16:45 BST
CPD: 12 CPD hours upon successful completion
Who should attend
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.
What you'll learn
By completing this course, you will be able to:
- 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
Course overview
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. In the short video below, our training course leaders Sabine Ruehle MTOPRA (Director Regulatory Affairs, Boyds Consultants), and Kathryn Parsley (Vice President Regulatory Affairs, Complement Therapeutics) explain the benefits of attending this course.
Experts will provide insights, from both an 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.
Download Programme
Course presenters
The expert presenters for this course will be announced soon.
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,250.00 + VAT* |
Standard Price
Non-member |
£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 all attendees, regardless of your country of origin. 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.
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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.