Are you interested in learning more about EU GMO considerations in light of the centralized CTA submission under the EU Clinical Trial Regulation 536/2014? Our upcoming webinar on October 26th will provide you with profound insights into the forefront of regulatory evolution.
Our expert speakers will guide you through the EU GMO framework, the environmental risk assessments, and the EMA action plan attempting to create an approach to clarify and harmonise national GMO requirements.
You can choose between one of 3 sessions available for this webinar on October 26th:
- Session 1: Thu 26 Oct, 6am ET | 11am BST | 12pm CEST
- Session 2: Thu 26 Oct, 10am ET | 3pm BST | 4pm CEST
- Session 3: Thu 26 Oct, 2pm ET | 7pm BST | 8pm CEST
FREE WEBINAR TOPIC
“Navigating GMO Landscape following the EU Clinical Trial Regulation 536/2014 implementation”
Agenda:
- What is a GMO and a GMM?
- Introduction to EU GMO legal framework
- GTMP GMO environmental risk assessments
- GMO considerations and CTR (EU) No 536/2014
At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.
About our expert speakers
Marcelina Rybianska
Regulatory Affairs Director, Strategy, Ergomed
Marcelina has 15 years of experience in global regulatory affairs, supporting Sponsor companies in the execution of successful regulatory strategies for their clinical research programs. She provides Ergomed clients with regulatory solutions and consultancy services across a variety of projects and therapeutic indications.
Lara Stevanato, PhD
Regulatory Affairs Associate Director, Ergomed
Lara joined Ergomed in 2023 and within the Regulatory Affairs department is the Biologics and ATMP CMC and nonclinical subject matter expert. She possesses a PhD in Biotechnology with over 20 years of CMC and clinical development experience in both the Biopharma and CRO industry. Her focus has been on identifying and addressing drug development challenges in the rare disease and oncology space.
