Warren Jameson, Ph.D Email & Phone Number

Magherafelt, Gb

United Kingdom

United Kingdom

United Kingdom

Working with clients in review and if needed, create documentation for their Quality Management System and technical documentation for Invitro diagnostics devices for IVDR compliance/CE Marking and FDA submission such as 510(k) and Emergency Use Authorisation (EUA). Significant experience in carrying out training, creating documentation and creating technical documentation such as:Performance evaluationPost Market Surveillance Analytical Performance Clinical Performance Scientific ValidationLabelling information Regulatory assessment for companion diagnosticsDesign dossiersInstructions for useFurthermore, creating promotional material such as webinars and blogs on changes to the IVD industry. Carrying out training on IVDR compliance for clients. Supporting medical writing, editorial and peer review of literature searches, publications, clinical performance reports and white papers. Supporting IVD registrations and regulatory assessments in UK, EU, Canada, China and ROW countries.

United Kingdom

Northern Ireland

My duties include ensuring compliance with relevant legislation across the organization, ensuring that all managers and responsible individuals develop and maintain their part of the Quality Management System. Dealing with Clients and exceeding customer requirements and expectations. Leading and supporting quality initiatives across the organization. Maintaining and carrying out Quality audits to ensure compliance and improving the business. Managing Quality documentation, Risk assessment, Risk Management and reporting on Quality Management activities to Managing Director. Managing internal audit schedules and auditors. Ensuring that certification to Quality Standards and registration to care standards is achieved and maintained this includes ISO9001and CQC. Auditing suppliers for business activity withknowledge of ISO13485:2016, ISO17025:2017, MDSAP, ISO19011 and increasing knowledge for the upcoming IVDR regulation. Furthermore, developing Policy within the company on a large range of issues which include Health and Safety, Data protection, Privacy and Quality. Moreover, manage changes within the company such as new services availability or implementation of corrective action and/or preventative in business and operations processes.

Antrim

Research and Development of new biological quality controls to be used in diagnostic clinical chemistry analyzers as Project Lead. This involves the management of multiple projects, which covers Regulatory Documentation such as Design initiation, Design Scope, Design history, Verification and Validation of the project and transfer of product.Formulating/developing products and meeting the projects’ design scope. This involves working with and managing both internal and external collaborators and service providers.I can assemble, interpret testing data and manage projects to meet deadlines. I can present data/project summaries to senior management with emphasis on project completion with cost and budget. I can manage testing of trials, coordinating with other team members and liaise with other multi-skilled operation departments. I have experience in communication and development of projects with external opinion leaders/clients on custom product feasibility. This is through expert knowledge and experience in performance and stability. Finally I have experience with product completion, with intention of new product launch and working with other departments for endorsement. In addition, experience within Quality Control which includes testing of newly formulated products and determining whether they meet design and regulatory specifications after manufacture, before release.Experience in resolving technical and customer queries when required. Ensuring products meet specified design specification for submission to external requirement organization, such as FDA, for registration and other quality related stability requirements. Analyzed and submitted results into international QC/QA schemes. All activities mentioned are carried out through ISO13485 standard and significant experience in product development and management using this standard through good manufacturing/development practice.

Haematology/Oncology Department, Belfast City Hospital.

The aim of my project was to determine effect of histone deacetylase inhibitors (HDACi) and novel microtubule targeting agents on CLL cells that are in a state of pro-survival stimulation (CD40L and interleukin 4) that can cause chemotherapy resistance. Results indicate that pan-HDAC inhibitor blocks up-regulation of c-FLIP in CD40L/IL-4 setting, this causes the activation of initiator caspase 8 resulting in apoptosis. Furthermore, combinations of HDACi and a novel mi-crotubule targeting agent caused a synergistic apoptotic effect.BACKGROUND:Chronic Lymphocytic Leukaemia (CLL) is the most common haematological disorder in the western world. It is characterized by an expansion of mature monoclonal CD5+ B-lymphocytes, with a clinical presentation of accumulating cells in the peripheral blood. Within CLL, two subtypes have been defined by prognostic somatic mutations, unmutated (UM) or mutated (M) in the Immunoglobulin heavy chain variable genes (IgVH). The accumulation of these cells is due to a deficiency in the apoptotic machinery and increased proliferation of cells. Previous CLL research has shown that these B-Lymphocytes have survival advantages either due to genetic alterations or through interactions with their microenvironment contributing to the pathogenesis of the disorder and chemotherapy resistance. An example of such interactions is with Th1 Helper T-lymphocytes expressing CD40L (CD154) and interleukin 4 (IL-4) in lymph nodal regions and with bone marrow stroma. As an inhibitor of apoptosis, c-FLIP (cellular FLICE-Inhibitory Protein) has been found to be overexpressed in a range of human cancers, expressed as long (c-FLIPL) and short (c-FLIPS) splice forms. This catalytically inactive Caspase8/10 homologue has been identified as part of the extrinsic apoptosis pathway. C-FLIP has been found to be overexpressed in multiple cancers; these include colon, non-small cell lung and non-Hodgkin’s lymphoma.

Maghera

Work as part of a team to provide a high quality service to the general public, in a sporting environment

Doctor Of Philosophy (Ph.D.), Chronic Lymphocytic Leukaemia (Haematology/Oncology)

Bachelor Of Science (B.Sc.) With Dipolma In Industrial Studies (Dis), Molecular Biology