PCI Clinical Services is bringing its expertise to the stage at Cell and Gene Therapy World (January 17-20, 2017) with an international case study on the remote Qualified Person (QP) certification of Advanced Therapy Medicinal Products (ATMPs).

On January 19 at the Hyatt Regency, Miami, FL, Shawn Murtough, associate quality director, PCI Clinical Services, will outline the key challenges and solutions that can arise during QP certification of ATMPs. The presentation will be part of a wider session entitled, “How are ATMP companies dealing with late-phase clinical and commercial scale logistics challenges in Europe?” In his case study, Dr. Murtough will explore the evolving GMP framework for ATMPs and consider whether new requirements for falsified medicines and data integrity can be fully applicable to ATMP supplies.

During this presentation, Dr. Murtough will also consider how the approach to QP certification differs between EU and non-EU manufactured ATMPs and the specific challenges that the remote QP faces when certifying ATMPs for human use.

“Cell and Gene Therapy World is a global stage to demonstrate how our leading expertise and technology helps to address and resolve the new problems faced by pharma companies in this rapidly advancing space,” said Dr. Murtough. “The insight that we will be sharing from PCI’s real world experience in cell therapy, gene therapy, and other ATMP’s will complement the wider session, adding realistic and practical detail and giving attendees a better grasp of how to overcome the logistics of the clinical challenges often encountered. The event promises to be a fascinating insight into this growing therapeutic area.” said Dr. Murtough.

For more information about Cell and Gene Therapy World visit www.bioleaders-forum.com.