Speakers
Elspeth McIntosh, MBA, RN
Director, Castle Pharmacovigilance Ltd, United Kingdom
Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.
Louise Woodward, PhD
UK QPPV and Local Safety Responsible, Roche Products Ltd, United Kingdom
Louise began her career in pharmacovigilance over 20 years ago and has held a variety of roles, including Safety Advisor and Team Leader within a UK Safety function and Clinical Safety Scientist within a Global Safety department, gaining experience in all aspects of PV. She moved to work with EU QPPV Office roles for over 7 years, as PSMF Manager/Process Owner and also as a PV Governance and Policy Leader. Louise has been the UK Local Safety Responsible for Roche Products Ltd for over a year now and took on the role of UK QPPV in October 2021.
Helen Fiddes
Head of Patient Safety, UK and Ireland, Bristol-Myers Squibb, United Kingdom
Helen is Director of Patient Safety, UK/IE based in the UK at Bristol-Myers Squibb (BMS). Helen joined BMS in 1998, initially working in Medical Information and then transferring to Patient Safety where she has developed her career, holding positions of increasing responsibility. Helen currently leads a team of 11 staff responsible for the implementation of complex Risk Management activities and Pharmacovigilance Operations.?? Prior to BMS, Helen worked in research and in community pharmacy and holds a bachelors in Pharmacy, from the University of Strathclyde.?
Lauren East
Head Pharmacovigilance and Medical Information / UK QPPV, Abbvie, United Kingdom
Lauren is a scientist with over 20 years experience across a variety of different roles within the Pharmaceutical Industry within both R&D and Commercial functions. Lauren started her career journey in 2000 within Medical Sales with Servier Laboratories and moved to GSK in 2003 where she steadily progressed in a variety of R&D roles moving into a Head of MI/PV role in 2019 to manage BREXIT activities. Lauren moved to AbbVie in 2020 as UK National Contact for Pharmacovigilance progressing to UK QPPV in 2024. In her role as UK QPPV Lauren leads the creation and maintenance of the UK PSMF and manages PV compliance of AbbVie’s patient support programmes and risk minimisation activities.
Rory Littlebury
Head of PVSO and QPPV Office, GlaxoSmithKline (GSK), United Kingdom
Rory has over ten years’ experience working at the MHRA, and two years working at GSK in Safety Governance. Rory’s experience includes engagement with a variety of stakeholders, from multi-national pharma companies to healthcare professionals and patients, giving a well-rounded view of the difficulties and challenges faced by those in, or affected by, the regulations of pharmaceuticals.
Sophie Radicke, MSc
Head of GPvP and Lead Senior Pharmacovigilance Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sophie is the Head of the MHRA GPvP Compliance Team and a lead senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance inspections and refining the MHRA's GPvP inspection programme. Inspector training, the development and update of pharmacovigilance legislation and guidance as well as stakeholder engagement and education continue to be a key part of her work. In previous roles, Sophie was responsible for the assessment of safety variations at the MHRA, and worked in medical information and on a regulatory affairs project in industry.
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