Qualified Person (QP) Oversight — Know how the new rules for importing finished investigational medicinal products (IMPs) into Great Britain from approved countries affects a clinical trial supply? As of January 1st, 2022, IMPs imported into Great Britain from approved countries (EU) will require a UK Manufacturing and Import Authorisation (MIA(IMP)) holder to have in place an assurance system to check that these IMPs have been certified by QP before release to the trial.
This webinar will describe:
- The importation routes available — direct to site or through a UK Distribution Hub
- The authorisations required by the UK MIA(IMP) holder and the clinical trial sponsor
- The assurance system required of the UK MIA(IMP) holder
- The trial documentation required by the UK (IMP) holder
- How Sharp provides the UK QP oversight of these imports
Importer of Record (IOR) — Know what importer record means and its responsibilities? How will a supply chain be affected with the new QP oversight regulations introduced? What changes has Brexit brought when importing 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.
Who Should Attend?
- Clinical Trial Supply Project Managers
- Study Managers
- Clinical Trial Director
- Sourcing Managers
- Clinical Trial Project Manager
- Program Manager
- Qualified Person (QP)
- Anyone working on setting up an oral solid dose clinical trial
What You Will Learn
- The requirements for importing finished IMP into Great Britain from an approved country
- What documentation needs to be provided to the UK (IMP) holder providing the QP oversight service and how the documentation is used.
- Learn importer of record responsibilities and common associated shipping terminology
- Understand how Sharp can assist when importing to the UK following Brexit.
Sharp Clinical Services
Sharp is a global leader in clinical supply chain services and pharmaceutical packaging. For more than 65 years, we’ve provided solutions to pharma and biotech clients from phase I trials through to commercial launch and lifecycle management. Learn more at www.sharpservices.com.