Physician and pharmacovigilance leader with more than 26 years of experience as a senior regulator, QPPV, auditor, trainer, and serial entrepreneur. Working in intelligent automation in PV for over 10 years, with the last 4 years dedicated to hands-on development and implementation of generative AI and AI agents in PV operations, including the validation of such systems and their defence before auditors and inspectors. Faculty member of DIA’s AI in PV training course and lecturer at the European Course in Pharmaceutical Medicine. Fellow of the International Society of Pharmacovigilance. Educated at Charles University in Prague, Imperial College London, with additional executive education in business and agentic AI from Harvard and MIT.

Gro Laier has been working within Pharmacovigilance for more than 25 years of these 1 year at Base Life Science, 4 years at Leo Pharma, 16 at Novo Nordisk, two at The Danish Medicines Agency and two at H Lundbeck. She graduated as a physician from University of Copenhagen in 1987. After a few months employment as a Register at a hospital in Copenhagen, she worked for 7 years within toxicology, before she took a position at the Danish Medicines Agency and started a long career within Pharmacovigilance.

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.

Mr Scheiner started his career lecturing Database Design and Database Management at the University of Technology, Sydney (1997-2000). Since then stayed in ICT technical and leadership roles in private sector and EU regulatory agencies, including EMA where he led the technical development of EudraGMP, EUTCT, EU Clinical Trials, ISO-IDMP and others. He has always focused on implementing complex data pipelines starting from data collection (mostly EU-wide), evaluation, processing, analytics as well as learning from the data.