On June 25, 2020, from 11.00 to 13.00, the AICRO training webinar will be held. The webinar is entitled: The concept of “vigilance” in clinical studies broadens the boundaries: from experience on the drug to the medical device. The regulatory background, language and methods of action: compared experiences.
It will be an interactive seminar, although in webinar mode, where the requirements of pharmacovigilance in the context of clinical trials will be addressed, to then discuss the imminent need to adapt the “surveillance” activity also to the medical devices field. The speakers will refer to the current legislation and share direct experiences with the participants, offering a multifaceted panorama for different actors: CROs, Sponsors, Clinical Trial Centers. Mariagrazia Felisi, Clinical Research Director at Consorzio per Valutazioni Biologiche e Farmacologiche, will be among the speakers of the webinar and will provide an overview of regulatory landscape on the drug, describing the role of the User in Eudravigilance and the delegation process.
More information on registration modalities and the agenda of the event is available at this link.