This webinar/presentation aims to elucidate the complexities associated with initiating a multi-country clinical trial involving an investigational medicinal product that contains or consists of a GMO, considering the perspectives of both sponsors and investigative sites. The webinar will provide a comprehensive overview of the regulatory framework, with particular emphasis on the European Union, where harmonization has been achieved in the domain of clinical trials pursuant to the Clinical Trials Regulation (CTR). However, regulatory fragmentation endures with regard to GMO legislation, as the pertinent directives have been transposed variably across Member States.
Registration instructions: A dedicated web-platform will be used for registration.