The webinar will provide an introduction to the EU legal frameworks for conducting clinical trials with investigational medicinal products containing or consisting of Genetically Modified Organisms (GMOs). It will focus on a case study in Belgium, elaborating on the regulatory requirements and the involvement of local competent authorities in accordance with the deliberate release directive.
Agenda:
- Overview of EU GMO Legal Framework
- Belgium – GMO Case Study for a CTD
- Deliberate Release Application Process
- Lessons Learned and Recommendations
About Our Speakers
Lara Stevanato, PhD
Associate Director of Regulatory Affairs
Amila Djulovic, MPharm
Regulatory Affairs Specialist – Study Start up and Regulatory
If you have any questions about our webinar, feel free to contact us.