Umit Kartoglu is a medical doctor and has a doctorate degree in public health. He is co-founder and CEO of Extensio et Progressio SARL. Umit began his career in Turkey, where he served at all levels of the national health system for over 10 years. He joined UNICEF in 1994 and proceeded to serve at the Headquarters of World Health Organization as a scientist from 2001 to 2018. Umit brought to life the WHO-UNICEF Effective Vaccine Store Management Initiative; the Global Training Network for Vaccine Management; the Performance, Quality and Safety (PQS) Initiative, and the Global Learning Opportunities (GLO) Network. He received the 2011 and 2013 Ludwig Rajchman Public Health Award for his research on shake test to differentiate aluminum adjuvanted vaccines affected by freezing. He is the author of four books and many manuscripts published in peer-reviewed journals.
Kevin O’Donnell is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the Irish Medicines Board), in Dublin, Ireland. He has been with the HPRA/IMB since 2001 and is a Senior GMP Inspector. He is also responsible for a number of compliance-related programmes at the HPRA, including the Quality Defect and Recall programme, the Sampling and Analysis programme, and the Advertising Compliance programme. He obtained his PhD in the field of Quality Risk Management (QRM) from the Dublin Institute of Technology in 2008. He is currently Chair of the PIC/S Expert Circle on QRM.
James Vesper, MPH, PhD established and is president LearningPlus, Inc., and has had more than 30 years experience in the pharmaceutical industry, including 11 years at Eli Lilly and Company. Dr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis. Since 1991, he and his firm, LearningPlus, have worked with pharma/biopharma, device, and blood products organizations around the world consulting on risk management, performance solutions and custom GMP learning events. He has been a special advisor/consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities working as a mentor and instructor for a number of different learning courses. Dr. Vesper has written five books, including Risk Assessment and Risk Management: Clear and Simple and multiple technical articles. He has a BS in biology (Wheaton College), an MPH (University of Michigan School of Public Health), and a PhD in Education from Murdoch University in Perth, Western Australia. Dr. Vesper may be contacted at firstname.lastname@example.org.