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 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 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 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, gaining extensive experience across the pharmacovigilance system. She held roles supporting the EU QPPV, providing both operational and strategic input into the maintenance and continuous improvement of the pharmacovigilance system. This experience ultimately led to her role as Global Process Owner for the Pharmacovigilance System Master File (PSMF) within 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.

Based in the UK, Anne is an independent consultant in Regulatory Affairs and Pharmacovigilance. She has worked within the pharmaceutical industry for over 35 years in roles which have included EU QPPV, UK QPPV, UK NCP, and PV Auditor. Her current client base consists of small companies, MA Holders in the UK and/or EU.  As a mother and a grandmother, with a dog to walk, she is now looking towards retirement but can't quite seem to let go!

Anastasia has been an GPvP inspector for 4 years, with 8 years in total spent at the UK Medicines Regulator. Her PV experience ranges from product information quality and safety variations, ICSR case processing, signal assessment and management, as well as governance.  Her academic background is in biochemistry, for which she obtained a BSc from the University of York.

Jo Elsden is a UK/EU QPPV and senior Pharmacovigilance professional with over 20 years’ experience across pharma, CROs, and consultancy. She has led global PV teams, overseen safety systems for clinical and post-marketing products, and supported numerous organisations with GVP compliance, audits, inspection readiness, gap analysis and PV improvements. As Director of Windsteer Consultancy, Jo now provides specialist PV expertise and practical, real-world QPPV support to small to medium companies.  She is also an active member of the PIPA committee and QPPV working  group.

Kathryn is a Benefit Risk Evaluation Assessor in the safety and Surveillance Group at the MHRA. She joined the Agency in 2004 since which time she has developed extensive knowledge of medicines regulation and legislation at national and international levels. Kathryn has gained broad experience of Pharmacovigilance across several therapeutic areas including anticoagulants, cardiovascular and respiratory medicine, diabetes, obstetrics and gynaecology, infections, and non-steroidal anti-inflammatories. Kathryn has a particular interest in risk management plans, medication errors, and digital health solutions. 

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.

I began my career in the pharmaceutical industry over 25 years ago and have held a wide variety of roles across pharmacovigilance. Throughout my career, I have gained extensive experience and built a strong understanding of all aspects of PV. More recently, I have specialised as a subject-matter expert in risk management strategy and benefit–risk, supporting the development and implementation of robust safety approaches throughout the product lifecycle.

Payal Gupta is an accomplished pharmacovigilance professional with over 15 years of experience across the pharmaceutical and clinical research sectors. She currently serves as Senior Patient Safety Partner and RMP-IC at Roche, UK, where she aligns local patient safety strategies with broader organisational goals and acts as the primary contact for Risk Management Strategy implementation and oversight. Prior to Roche, she held senior leadership roles at global CROs, including PPD and Syneos Health, managing global safety reporting teams and regulatory intelligence initiatives. Payal holds an MS in Pharmacology and Toxicology and is a strong advocate for advancing patient-centric, proactive pharmacovigilance systems.

Emma joined the Medicines and Healthcare products Regulatory Agency (MHRA) in 2009 and is an assessor specialising in post market surveillance of medical devices.   

Pramod Wable is an accomplished professional with extensive experience in Leadership, Strategy, Innovation, Compliance, Quality Management, Data Analytics, and Auditing in Good Laboratory Practice (GLP), Good Clinical Practice (GCP) & Good Pharmacovigilance Practice (GPvP). Proven track record in effectively leading cross-functional teams to achieve strategic objectives and enhance operational efficiency. He is skilled at fostering a culture of compliance and continuous improvement within fast-paced and regulated environments. With a commitment to excellence and innovation, I continually strive to enhance quality standards and regulatory compliance while leading teams to meet organizational goals.

Valentina brings over 18 years of expertise in the pharmaceutical sector, including roles in Medical Affairs and Pharmacovigilance. She has been with Bayer for 12 years, during which she has occupied multiple positions within the local Pharmacovigilance organisation. Since 2016, Valentina has served as the Pharmacovigilance Country Head for the UK, and in 2021, her responsibilities expanded to include Ireland. In 2022, she assumed the role of UK Qualified Person for Pharmacovigilance (QPPV), further solidifying her leadership in the field.

Jason joined the Medicines and Healthcare products Regulatory Agency (MHRA) in November 2006 as a Good Clinical Practice (GCP) Inspector. He progressed to Senior Inspector in 2015, Lead Senior Inspector in 2017, and became an Expert GCP Inspector and Head of the Compliance Expert Circle in April 2022. Between 2011 and 2022, he worked across both GCP and Laboratories Inspection teams, conducting inspections of sponsors, CROs, analytical laboratories, bioequivalence trials, and GLP facilities. In his current role, he leads the MHRA’s Expert Inspectors and contributes at national and international levels. He holds a BSc (Hons) in Biomedical Science and a postgraduate diploma.