Louise is the QA Regulatory and Governance Affairs Manager for University of Leeds (UoL) and Leeds Teaching Hospital Trust (LTHT), specialising in the management and oversight of Non-Commercial Clinical Trials of Investigational Medicinal Products (CTIMPs). Louise has experience in trial management, protocol review / development, data capture, Pharmacovigilance, regulatory reporting and NHS ethical review. Her current role is to oversee the LTHT / UoL CTIMP portfolio, to ensure all trials are conducted in line with the applicable regulations. This includes review and approval of all trial protocols in advance of regulatory submission, the assessment of clinical trial amendments, Pharmacovigilance activities and protocol deviations / series breaches. In 2015 Louise acted as organisation lead for an MHRA inspection, and is currently driving the resulting corrective actions. Prior to her current post, Louise has four years’ experience as a Clinical Trials Quality Monitor, assessing compliance to Good Clinical Practice and the Medicines for Human Use Clinical Trials Regulations across a range of disease disciplines and therapeutic areas.
The new Health Research Authority (HRA) has changed the landscape for NHS governance for both commercial and non commercial sponsors. This will be an interactive session sharing experience on the impact of the new HRA processes on universities and other non commercial sponsors. Case studies for both IMP and non IMP studies will be shared …
|Theme:||Policy and Governance|
|Speakers:||Clare Skinner, Ms Louise Brook|