Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician, and Certifications as a Quality Engineer and in Six Sigma. He is Chair of DIA's GCP-QA Community, on the Core Committee for NJ CDISC User Group, and former Chair of Statistical Taskforce for the Animal Health Institute. Terry recently completed a 3 month Fellowship in Kenya to improve capacity to run oncology clinical trials.

Maria Kellner is the President Virtua Pharma and holds master’s degrees from Temple University in Regulatory Affairs and Quality Assurance and University of Pennsylvania in Telecommunications. Her background includes working in CROs, pharmaceutical companies, and a clinical trial software development enterprise, and she played a key management role in the largest pharmaceutical and CRO data exchange initiative to date. Since 2015, she has been running her own consulting company, Virtua Pharma Technology. Maria is in the process of transforming Virtua Pharma Technology into a ‘Validation as a Service’ company. Her interest in computer system validation comes from her years spent as a developer as well as her love for process improvements!

Kamila Novak holds MSc in molecular genetics. She has been involved in clinical research since 1995, having worked in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant and incorporated in 2019. Her business activities include auditing, SME consulting for QMS establishment and process improvements, medical writing, and training. Kamila is a certified Lead Auditor for ISO 9001, ISO 31000, ISO 13485, and ISO 15189, a trained auditor for ISO 14155, cGMP-QMS, and GXP. She is a member of the EMWA, the DIA, the CPD UK, the SQA, the Association for GXP Excellence, the WMDO, and other professional societies. In the SQA, she is the Chair of the Beyond Compliance Specialty Section.