New Qualified Person Oversight Regulations When Importing Investigational Medicinal Product to the UK

Lisa Parkhouse, Quality Manager / QP, Sharp

Lisa has 25+ years’ experience working across a variety of quality roles at Sharp and has deep expertise in UK QP requirements for batch certification, UK QP Oversight of Investigational Medicinal Product (IMP) imported from EU, Quality Management Systems and GMP manufacturing.

Providing essential guidance to ensure QP batch certification requirements are in place so IMPs can reach patients quickly and safely, Lisa plays a pivotal role in the clinical trials that Sharp supports.

Integral to Sharp’s quality culture, she supports client and regulatory audits, quality investigations and trains Sharp colleagues on current GxP requirements as part of Sharp’s commitment to the reliable, secure delivery of drugs that make a real difference to people’s lives.

Stewart Howells, Logistics Team Manager, Sharp

Stewart has worked within the clinical trial industry for 14 years, with a focus on the distribution of clinical materials globally. He is currently working as the Logistics Team Manager at Sharp Clinical Services UK, located at our Rhymney facility in South Wales. Stewart’s main responsibilities at Sharp include the overseeing of all activities associated with UK imports and exports along with supporting the full supply chain of clinical trial supplies, including the selection and management of third-party depots.