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.

Sophie is the Head of the MHRA GPvP Compliance Team and a 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.

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 at Bristol-Myers Squibb, based in Uxbridge, United Kingdom. Managing a team of nearly thirty Pharmacovigilance professionals, working on a diverse portfolio including three Pregnancy Prevention Programmes for thalidomide and its derivatives. Been in the industry and pharmacovigilance for over 20 years. Prior to that community pharmacy, after graduating from the University of Strathclyde, in Glasgow.

Lauren is currently Head of Pharmacovigilance and Named Safety Contact for Abbvie UK. Lauren has worked in the pharmaceutical industry for over 20 years in a variety of commercial, medical and PV roles which most recently has seen her take on the challenge of leading a team of PV professionals successfully through the changing BREXIT landscape.

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.

Francesca Blythe advises international clients on a wide range of data protection, privacy, cybersecurity, and emerging technology issues. She has in-depth experience across multiple industries, including asset management and private equity, payments, technology, retail, e-commerce, and manufacturing. Francesca has a particular focus on life sciences, where she advises on a broad range of issues in relation to clinical studies/investigations, secondary research, digital health, and use of novel technologies (including artificial intelligence). Francesca co-leads Sidley’s benchmarking group for in-house data privacy professionals (dplegal) in the life sciences sector.

Helen is a Pharmacovigilance Inspector at the Medicines & Healthcare products Regulatory Agency (MHRA). Prior to joining the MHRA she spent several years in Industry, where she accumulated knowledge across the PV system. She held roles supporting the EU QPPV, which ultimately led her to become the Global Process Owner of the PSMF for a large pharmaceutical organisation.

Rob Massouh, is the Head of Safety (PV) Risk Management and Benefit-Risk Evaluation at GSK. In this role, he serves as the subject matter expert in risk management strategy and benefit-risk evaluation. Rob was previously at the MHRA working as a Scientific Assessor within the Benefit Risk Management Group. Rob is a registered Pharmacist and received his MPharm at the University of Manchester.

Anne Carter is a contract QPPV (UK and previously EU), UKNCP and provides bespoke PV systems for a number of small pharma companies. Anne began her career in the pharmaceutical industry in 1989 and has experience within regulatory affairs, pharmacovigilance and medical information. Carter & Associates Ltd was founded in 1997 to provide regulatory affairs and pharmacovigilance services primarily but not exclusively to small pharma companies.

Anastasia has been working at the MHRA for 5 years. Her PV experience ranges from product information quality and safety variations, ICSR case processing, signal assessment and management, as well as governance. More recently Anastasia has joined the PV inspector team at the MHRA to focus on compliance. Notable career highlights includes appointment as one of the first COVID-19 vaccine safety assessors monitoring the benefit-risk profile post vaccine roll-out. Her academic background is in biochemistry.

Silvia has been working at the MHRA as Pharmacovigilance Inspector since 2023 following over six years of experience in the pharmaceutical industry within pharmacovigilance and drug safety. Silvia holds a Pharmacy degree.

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having previously held a split inspection role between the GCP and Laboratories teams. As an Expert Inspector his role includes the provision of technical leadership, guidance and support. Jason has a degree in Biomedical Science and a Postgraduate Diploma in Pharmaceutical Technology & Quality Assurance. Previously Jason spent seven years in the UK National Health Service working in hospital pharmacy (including clinical trials & manufacturing).