When: 25 - 26 March 2025
Course overview
This two-day course led by industry experts will give you an understanding of the specific regulatory requirements for medicines which consist of or contain genetically modified organisms (GMOs), such as many advanced therapy medicinal products (ATMPs) and viral vector-based vaccines, and how to navigate these. This interactive course covers not just the theoretical requirements, but also includes case-studies on strategy planning and dossier preparation for GMO applications for clinical development in Europe, the UK as well as global considerations.
This course is led by industry experts and will provide insight into:
- Current legislative requirements for GMO risk assessments, from clinical development up to licensing in Europe and the UK
- Product types including gene and cell therapies such as genetically modified cells, viral vectors, gene edited products and vaccines
- Dossier requirements and options (including use of and experience with “common application forms” [CAFs], “SNIFs”)
- Steps to perform an environmental risk assessment [ERA] and complete regulatory GMO application forms
- Global considerations for genetically modified products including North America and APAC
- Strategic planning of 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
- Latest and upcoming developments in an ever-changing landscape, from an industry and agency perspective
Benefits to delegates
- Develop/expand your knowledge on the GMO regulatory framework
- Learn to understand the pitfalls of 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 will be uploaded soon.
Presenters
This course has been developed by the TOPRA Biotech, Cell & Gene Therapies SPIN, with the presenters having over 100 years of combined experience in the GMO space and a proven track records of regulatory submissions supporting both clinical trials and marketing authorisations, and publications in the GMO space.
Presenters include:
- Erik Schagen, Director Regulatory Sciences - ProPharma
- Kathryn Parsley, Vice President Regulatory Affairs - Complement Therapeutics
- Leoni Mahal, Senior Associate Regulatory Affairs - Achilles Therapeutics
- Myra Widjojoatmodjo, Scientific Director - Johnson & Johnson
- Sabine Ruehle, Director Regulatory Affairs - Boyd Consultants
Suitable for
- Regulatory professionals who are new to GMO applications or have previous experience they would like to build on
- Regulatory professionals who wish to hear about the latest and upcoming developments for GMO submission requirements
- Regulatory professionals who wish to gain hands-on experience on strategic planning and GMO dossier preparation
- Anybody involved in GM medicines drug development who wishes to avoid potential delays due to GMO requirements
Pricing
Standard
- Member: £1,050+VAT*
- Non-member: £1,250+VAT*
Discounted places
A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.
- Those working for regulatory agencies, government agencies or academic institutions:
- Members: £787.50+VAT
- Non-members: £937.50+VAT
- Those working for charities, patient groups or in full-time education:
- Members: £525+VAT
- Non-members: £625+VAT
*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.