People who move patient safety forward

Dr Amrit Gill (MD, MBA) leads global pharmacovigilance at Opella, the consumer healthcare company formerly part of Sanofi. She has more than 18 years in pharmacovigilance and speaks regularly on patient safety, safety reporting in under-represented populations and the use of AI in PV.

Jean-Marc leads International Patient Safety at Roche in Switzerland, overseeing safety activities across Roche's markets outside the US. He has worked in drug safety and medical leadership at Roche and previously UCB, and has written on adaptive leadership in medicine.

Hina leads Global Patient Safety Science at Revolution Medicines, the oncology company developing RAS-targeted therapies. She was previously Executive Director of Safety Science at Erasca and Principal Director of Product Development Safety in Oncology at Genentech.

Dr Khaudeja Bano is a physician with more than 25 years' experience spanning patient care and global medical safety leadership. Before Genentech she held global safety roles for devices, diagnostics, medicines and combination products at Guidant, Abbott, AbbVie and Amgen. She holds a master's in clinical research from UC San Diego, is a certified Project Management Professional and chairs the Combination Product Coalition's post-marketing safety working group.

Sam heads Case Management in Worldwide Patient Safety at Bristol Myers Squibb, based in London. He joined BMS through its acquisition of Celgene and led the integration of the two companies' case processing, including moving the BMS safety database to the cloud. He speaks widely on case intake innovation and AI adoption in pharmacovigilance.

Calvin leads International Patient Safety at Bristol Myers Squibb. He holds an MSc in Pharmacovigilance and has worked in drug safety for more than two decades, starting in clinical safety in large pharma and going on to clinical and post-marketing roles in small and large companies, including medical information and Deputy EEA QPPV responsibilities. He is a contributing author to the textbook Pharmacovigilance: A Practical Approach.

Dr Alison Cave is Chief Safety Officer at the MHRA, where she leads the agency's work on the safety of medicines and medical devices used in the UK. A pharmacologist with a PhD in biochemistry, she began her regulatory career at the Medicines Control Agency and held senior roles in the MHRA's Vigilance and Risk Management of Medicines group and at the European Medicines Agency. She has also been Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and an Industrial Strategy Challenge Fund Director at UK Research and Innovation.

Michael is a former MHRA Senior Pharmacovigilance Inspector. He joined the MHRA in 2003, helped build the UK's statutory PV inspection programme and managed its inspectors until 2008. Before that he was a GLP auditor at HLS and Zeneca and a pharmacovigilance auditor at Novartis. He now leads regulatory compliance work at Johnson & Johnson. He holds a BSc (Hons) in Applied Biology from Nottingham Trent University.

Mijal leads global GxP inspections and GVP audits at Kyowa Kirin International. She has more than 20 years in drug development at large and small pharmaceutical companies, multinational CROs and service providers, and has led many health authority inspections.

Dr Alex Bica is a board-certified physician and pharmacovigilance leader with more than 15 years of global experience in drug safety and clinical development. Based in Germany, he leads early-development and translational safety at CSL Behring. He is a Fellow of the Royal Society for Public Health and holds an MPH and an Executive MSc.

Dr Craig Hartford (MB BCh, MSc Med, PhD, FFPM) is a UK pharmaceutical physician specialising in benefit-risk management and pharmacovigilance for medicines and medical devices. He is a member of the Faculty of Pharmaceutical Medicine's Policy and Communications Group and co-authored a widely cited paper on artificial intelligence in pharmacovigilance.

Dr Julia Appelskog is an EU QPPV with more than 22 years in pharmacovigilance, quality and regulatory operations. She has led global PV teams at Bluefish Pharmaceuticals, TFS and Merck, and Nordic PV hubs at MSD, J&J and Sanofi Pasteur MSD. She holds a PhD in cell biology from the Karolinska Institute, has written two books on AI in pharmacovigilance and contributes to the EMA's AI working group on the General-Purpose AI Code of Practice.