Maarten Lagendijk is the deputy QPPV at MSD since 2019 and is based in the Netherlands. Maarten has over 20 years of experience in pharmacovigilance. He has previously worked for the Medicines Evaluation Board in different pharmacovigilance related roles as well as a national expert at the European Medicines Agency.  Maarten has been involved with DIA for many years and is part of the programme committee for the Global QPPV Forum since 2020. 

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.

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.

Angela has almost 20 years experience in PV with 15 years of functioning as a (deputy) QPPV. She provides customized pharmacovigilance support, including QPPV provision & responsibility for the clients pharmacovigilance systems. After her PhD in 2005, she started her career in pharmacovigilance & in 2008, she joined Organon to gain experience in PV during the different mergers taking place at that time. In 2010, she joined DADA Consultancy to start up a department of PV consultants to take on global and local responsibilities from clients in need of PV support. Her personal interests lie with Compliance management and auditing, as well as Risk Management and Medication Errors, & she recently obtained a MSc in Clinical Epidemiology.

Willemijn is the Executive Director Europe in the WorldWide Patient Safety Organisation in Bristol Myers Squibb. She is responsible for Patient Safety in the European region, including the Balkans, Baltics and distributor markets. Prior to this role she was responsible for the European markets, PV Intelligence & International Operations including the PSMF as well as Training and Outsourcing activities. Willemijn holds a Nursing Degree from the Netherlands, a BA (Hons) in Sociology from Goldsmiths college, University of London, UK and an MSc in Pharmacovigilance from the University of Hertfordshire, UK. Willemijn is co-chair of the EFPIA Pharmacovigilance Expert Working Group and Chair of the EFPIA International Pharmacovigilance Group.

Gemma Jiménez Sesé currently holds the position of Deputy EU and UKQPPV at Astrazeneca, based in Barcelona, Spain. Previously, she served as the EUQPPV at Almirall. With over 20 years of experience in pharmacovigilance, she has taken on roles with increasing responsibility. In pharmacovigilance, she has been involved in a broad scope of activities, encompassing safety in clinical development and support for marketed medicinal products, including small molecules and biologics. Beyond safety, she has led projects in late-phase development and product life-cycle management. Additionally, she is a member of the Program Committee for the DIA QPPV Forum

Sina is the Head of the QPPV Office & EU QPPV in the department Pharmacovigilance and Patient Safety and located in Germany. She has been with Abbvie 14 years. Prior to joining Abbvie, Sina studied veterinary medicine and wrote her PHD thesis in the Virology department, working group Immunology on bone marrow transplantation. In her free time, Sina loves spending time with her husband and two little girls and enjoys horse-riding.

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.

Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and engagement for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research".

Dr Georgy Genov is the Head of Pharmacovigilance Office, within Quality and Safety of Medicines Department, European Medicines Agency (EMA). The office oversees and manages lifecycle pharmacovigilance activities in the EU, including signal detection and management; evaluates the impact of regulatory interventions and develops pharmacovigilance guidelines and standards; ensures leadership, coordination and clear roles and responsibilities for a quality assured EMA’s and EU pharmacovigilance systems; collaborates closely with EMA scientific committees and working parties, in particular the Pharmacovigilance Risk Assessment Committee (PRAC). Oversees the development and maintenance of IT systems for pharmacovigilance.

Jessica is the Director of Patient Safety Excellence and an expert PV advisor in the AstraZeneca QPPV Office. She has been with the company for 9 years and held various roles within PV, including leading the global PV audit team. Jessica previously worked at Biogen in Switzerland as the Swiss QP and held several roles within Medical Affairs. She has thorough experience across multiple GxP areas both from a global and local perspective. Jessica holds a PhD in Immuno-oncology from ETH Zurich.

Aise Sukran RENDA is a Senior Inspector at the Turkish Medicines and Medical Devices Agency (TMMDA) with 14 years of international GMP and GVP inspection experience. Holding a BSc in Bioengineering and an MBA, her expertise encompasses computerised systems, data integrity and biotech. She is actively involved in shaping AI regulatory frameworks, serving as Chair of the PIC/S AI/ML Working Group under the PIC/S GVP Expert Circle. She is also a member of the EMA Drafting Group for EudraLex Volume 4 revisions, including Chapter 4, Annex 11 and the new Annex 22 on Artificial Intelligence. Her work focuses on strengthening pharmacovigilance and GMP oversight, including the compliant integration of AI across the product lifecycle.

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.

Pat Hawthorne works in the International Medicines Quality Organisation and is based at Eli Lilly in the UK. Primary responsibilities are leading the processes around the maintenance the EU PSMF and localised PSMFs and shaping affiliate vigilance.

Lilit is Global Pharmacovigilance Risk Minimization Physician and Deputy EU/UK QPPV at Galderma, based in Paris, France. With nearly two decades of experience in pharmacovigilance, she has held leadership roles at Bristol Myers Squibb and UPSA, where she established an independent global PV system. Lilit holds a medical degree in Pediatrics from the State University of Medicine in Yerevan and a Master's in Advanced Immunology from the Pasteur Institute in Paris.

Magnus Ysander is the EU and UK QPPV for the AstraZeneca group of companies since 2015. From 2022 he also has the same role for Alexion. Based in Gothenburg, Sweden he joined the company in 2002 and have had several specialist, oversight and line managerial roles within the global AstraZeneca pharmacovigilance organisation. Magnus is a MD and has previously worked as a certified Orthopedic Surgeon. He is a member of EFPIA Pharmacovigilance Expert Group and the Program Committee for the DIA QPPV Forum.

Deola Coker is an accomplished pharmaceutical executive serving as the Pharmacovigilance (PV) Excellence Director within the QPPV Office at AstraZeneca in the United Kingdom. Based in London, Ms. Coker possesses extensive expertise in structural drug safety monitoring, international regulatory standard-setting, and global risk mitigation. She holds a Bachelor of Science in Pharmacology and a Postgraduate Diploma in Pharmacovigilance from the University of Hertfordshire. In her senior leadership capacity, she drives global structural optimization and ensures that AstraZeneca's drug safety frameworks strictly align with evolving international health authority mandates

Fabian Heisig is leading the Global Drug Safety Department at Grünenthal since 2018 and was appointed as EU QPPV and UK QPPV. In addition, he is deputizing the Chief Medical Officer. He started his career at Grünenthal in 2007 and had various roles incl. leadership responsibilities in case processing, benefit risk management and clinical safety. He has expertise in the pre-marketing area as well as in the post-marketing area. He is a member of EFPIA Pharmacovigilance Expert group.

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 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.

Koen has over 15 years of experience in pharmacovigilance and more than 9 years as QPPV. Since summer 2021 he is the EU and UK QPPV for Galapagos, where he joined to help finalize the pharmacovigilance system in light of an upcoming transfer of a Market Authorisation. Prior to Galapagos he worked 10 years for Medtronic BioPharma, a small pharma entity in the medical device company Medtronic. Within this company he build up the pharmacovigilance system for the first pharma product of Medtronic. He has a Master in Biomedical Sciences, with a main focus on epidemiology and pathobiology.