Facultad
Julia Appelskog, MD
Head of QPPV Office and PV Intelligence, CSL, Sweden
Julia is a senior pharmacovigilance professional with over 23 years of global experience across the pharmaceutical, biopharmaceutical, and CRO sectors. She has served as the EU QPPV and held leadership roles in regulatory intelligence and pharmacovigilance strategy at large pharmaceutical companies. Julia is also recognised as an AI expert in pharmacovigilance and a strong advocate for innovation in drug safety. She is a published author, international speaker, and contributor to the EMA AI Working Group on the General-Purpose AI Code of Practice.
Philip Jones
Disease Area Cluster Lead in Safety Surveillance and Risk Management, Pfizer Ltd., United Kingdom
Philip Jones is a physician-scientist with over 15 years of industry experience in PV. He is Disease Area Cluster Lead in Safety Surveillance and Risk Management (SSRM) at Pfizer leading a global team of safety physicians managing the benefit-risk profiles of medicines. He leads the SSRM AI Group exploring the use of AI & automation in signal management, literature review & predictive safety & also Co-chairs the Pfizer Hepatic Injury Council. He has multiple publications in biomedical journals, several years of experience in clinical practice & is a regular speaker at international conferences.
Jan Kolouch, PharmD
CEO, Strategic PV Advisor, NextPV Services s.r.o., Czech Republic
PV professional with immense experience with critical PV processes gained through execution as well as its successful leadership and management. The key areas of Jan’s expertise are strategic consulting on full PV outsourcing including expert advice and guidance on the implementation of AI-powered safety systems, Safety data mining in global databases, ICSR Management, EV and XEVMPD maintenance, EU QPPV activities, signal management, PSMF development/maintenance, medical writing, and audits/inspections.
Representative Invited
European Medicines Agency
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