DIA EUROPE 2021

Clinical Trials involve all of the GXPs in their conduct, from GLP through to elements of GDP and of course includes GMP and GPvP. GCP is of course the foundation for the conduct of a clinical trial, however, without the others a trial is not possible. When we think about GMP and GCP there is of course a great overlap. GMP underpins the consistent manufacture and supply of the IMPs and GCP underpins efficient study management and compliance with applicable rules and regulation leading to desired outcomes. What are the most important aspects of the GCP/GMP interface? This session is split into 3 parts, in the first understand the legislation surrounding the GCP/GMP interface, how COVID 19 vaccines and therapies place greater importance on managing the interface and how advanced therapy medicinal products are bringing the manufacturing closer to the patient through personalised medicines. Clinical trials have becoming increasingly more complex over the years, and have becoming increasingly patient centric. We see the move from all patients’ drug supplies being handed over at the investigator site to some being delivered directly to their home. Where products are not simple tablets, nor a self-administered injection, how do we ensure that a responsible person is administering the medication. In terms of drug accountability, who is responsible for this in the patient home? In this part of the session, hear about the differences between a commercial supply chain and a clinical supply chain. Understand the challenges in direct to patient shipping and home administration. See the differences in drug accountability requirements depending on the trial and the product researched. And finally with new technologies the possibility to bring the trial closer to the patient is already here. In the Covid-19 pandemic the use of these technologies’ has increased to facility the continuity of the supplies. What are these technologies and what is the future. Then hear from our experts in a moderated discussion.