Notified Body Requirements for Drug-Device Combinations: Demystifying Article 117 The involvement of a notified body is an essential aspect of the regulatory process for combination products covered by Article 117, as it helps to ensure that the device component of your combination product is safe,...
Join the Cutting-Edge Conversation Are you ready to embark on an extraordinary exploration of Advanced Therapy Medicinal Products (ATMPs)? Get ready to immerse yourself in the dynamic world of ATMPs development and manufacturing, led by none other than Ion Tcacencu, an esteemed ATMP expert with...
Join our upcoming webinar, designed to untangle the intricacies of non-clinical challenges in drug development. It's imperative to recognize that beyond the clinical aspect, there exists a complex domain of non-clinical considerations that greatly influence the trajectory of drug development. These considerations range from understanding...
