WEBINAR DETAILS
  • About
    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
    • Q & A
  • Price
    Free
  • Language
    English
  • OPEN TO
    Everyone
  • Dial-in Number
    Please register for this Webinar to view the dial-in info.
FEATURED PRESENTERS
  • Webinar hosting presenter

    Lara Stevanato, PhD

    Associate Director of Regulatory Affairs
    With over 20 years of experience in pharmaceuticals and biotechnology, Lara is a regulatory affairs expert for cell and gene therapy products, leading regulatory efforts for 10+ CGTs, focuses on rare genetic diseases and pediatric trials....
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  • Webinar hosting presenter

    Amila Djulovic, MPharm

    Regulatory Affairs Specialist - Study Start up and Regulatory
    Amila brings nearly a decade of diverse experience in regulatory affairs to her role. Her expertise spans across Marketing Authorizations (MAs) and Clinical Trials, with a particular focus on GMO-related studies conducted across multiple EU...
    Full Profile
  • Webinar hosting presenter

    Ergomed Clinical Research

    With 25 years of experience, Ergomed offers custom-made clinical solutions for every stage of development from proof-of-concept to late-stage programs. Founded in 1997, Ergomed is dedicated to the provision of global specialized services in the...
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