Leading pharmaceutical provider PCI Clinical Services will bring its expertise to the stage at Cell and Gene Therapy World (17-20 January 2017) with an international case study on the remote Qualified Person (QP) certification of Advanced Therapy Medicinal Products (ATMPs).
On 19 January at the Hyatt Regency (Miami, FL, USA), Dr 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 Good Manufacturing Practice (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.
“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.
Dr Murtough is a certified EU QP for PCI, located at PCI’s Clinical Trial Center of Excellence in Bridgend, UK. Having graduated with a doctorate in pharmaceutical microbiology, he has worked in various roles within the pharmaceutical industry for the last 15 years. For the last 4 years, he has specialised in Cold Chain and Ultra Cold Chain logistics for clinical trials, which has included handling a wide range of product types including, cell therapies, viral vectors, monoclonal antibodies and vaccines.
PCI supports cell and gene therapies, as well the broader category of Advanced Therapeutic Medicinal Products (ATMP), in its expansive portfolio of Cold Chain and Ultra Cold Chain services for Clinical/Investigational medicines and Commercial therapies.
PCI’s expertise includes supporting therapies requiring cryogenic storage conditions with specialised procedure and infrastructure to ensure safety and efficacy, and recently announced expansion of its cryogenic storage to include both its European and North American operations. PCI will be exhibiting at Cell and Gene Therapy World from January 17-20 on stand number 136.
To hear more from Shawn Murtough and the PCI Clinical Services team register for Cell and Gene Therapy World by visiting http://www.bioleaders-forum.com/.