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.

With a background in academic and clinical medical practice paired with experience as Head of Data Science in Cabinet Office, Marinos, try to marry the scientific, statistical, medical and the analytical to deliver meaningful regulatory innovation which ensures innovation is applied for the public good.

Nicola is the UK QPPV for Jazz Pharmaceuticals based in the UK. She has over 18 years’ experience in Pharmacovigilance, in both pre and post-marketing settings within Global Drug Safety. She has extensive PV system knowledge, having held roles in Global Case Management, PSMF Administration and PV Intelligence, as well as acting as UK National Contact Person for Pharmacovigilance. Nicola joined Jazz in 2014 and has worked in Jazz’s EU/International PV and QPPV Office since 2021 and took on the role of UK QPPV for Jazz Pharmaceuticals in April 2023.

Claire is the Expert Pharmacovigilance Inspector at the MHRA. She has 10 years experience at the MHRA holding various positions within the MHRA Compliance Teams. Claire has led multiple high profile inspections as well as given a variety of presentations and talks at numerous events in the UK and overseas. In Claire's current role as the Expert Inspector, she is responsible for developing the strategy of the GPvP Compliance Team and aligning this with other GxPs across the MHRA. Prior to joining the MHRA Claire worked in Industry where she gained experience in a number of aspects of Pharmacovigilance and Medical Information.

Dionne is based in the UK and works in MSD's Office of the Global Qualified Person for Pharmacovigilance (GQPPV). Dionne is MSD's PSMF Owner and supports various key Global/EU and UK QPPV projects and tasks, such as EudraVigilance access, audits and inspections support and general project management, as needed. As a member of various PSMF industry groups, they share a keen interest in all things PSMF and the various approaches that companies take towards ensuring an efficient and compliant approach to PSMF management for the EEA, UK and globally.

Rachel joined the MHRA as a GCP Inspector in July 2019. Rachel conducts a variety of GCP routine and triggered inspections in commercial and non-commercial organisations, including Phase I units registered under the MHRA Phase I Accreditation Scheme. Prior to joining the Agency, Rachel was a Quality Manager at a global CRO having previously held a number of clinical research roles at Pharmaceutical Companies for over 10 years.

Dr Emma Cornforth joined the MHRA in 2004 as a scientific assessor. Emma now works in the Benefit Risk Evaluation Unit of Safety and Surveillance division. Emma has extensive experience in the assessment PSURs, renewals,  safety variations and RMP assessments. 

As the Programme Support Officer, I’m involved in strengthening programme governance and delivery for the MHRA’s AI Airlock programme. With experience in human resource management, business administration, stakeholder engagement and coordination of complex programme activities within healthcare and compliance-driven environments, I am currently associated with design, development and delivery of the programme. My focus lies in ensuring operational clarity and enabling functions of PMO landscape to effectively explore through structured, evidence-based approaches the regulatory challenge areas brought forward by AI technologies. Today presenting an overview of the AI Airlock programme - its objectives, governance framework and sandbox model.

Shazia Khalid joined the MHRA in 2000 in the renewals team. Shazia now works in the Benefit Risk Evaluation Unit within the Safety and Surveillance division. Shazia has worked in several teams and has extensive assessment experience of renewals, patient information labelling and package leaflets, safety variations, PSURs, and RMPs. 

James has extensive experience in pharmacovigilance and patient safety, with his most recent role on the Patient Safety Operations Leadership Team at AstraZeneca as Senior Director Device and Digital safety. In the past, James has been a Life Science Consultant, a Safety Scientist performing safety risk/signal management and a case processor. James holds a BSc in Psychology and an MSc and MBA with a focus on Patient Safety. In addition, he contributed actively to industry-wide initiatives through DIA and Transcelerate.