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...
Transitioning from preclinical to clinical development is a critical step in drug development, often accompanied by significant challenges. This webinar will explore key considerations from a clinical pharmacology perspective, and explore potential solutions to establish a robust plan for your First-In-Human study. Speaker: Tom Habraken...
Join the first webinar of our series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing on Thursday 16 January 2025. In this webinar, we will be covering the general aspects; giving you a brief introduction into regulatory affairs and the documentation required...
Join our second webinar of the series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing on Thursday 6 February 2025. Following our first webinar on general aspects on Thursday 16 January 2025, this webinar will delve deeper into the various documents required...
Join our third and final webinar of the series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing on Thursday 27 February 2025. This webinar will delve deeper into the various documents required for early development and highlight the importance of involving skilled...
