EUROVULCAN 2 | Panel #2: Vulcan Utilizing the Digital Protocol / UDP Project (was ICH M11)

Focus: Mission, Plans, Key Challenges, European Involvement

Chair: Panagiotis Telonis, Scientific Administrator, Chief Information Office, European Medicines Agency

Panelists & topics:

• • History of Clinical Research Protocol Standardization: Rebecca Kush, Co-Chair, Vulcan Advisory Council | Founder and President Emeritus, CDISC
  • M11 in US / Decentralized Clinical Trials in US: Ron Fitzmartin (online), Sr. Informatics Advisor, CBER (FDA)
  • The perspective of CROs in Europe: Yoanni Matsakis, Treasurer, EUCROF | Chairman of the Board and CEO, Telemedicine Technologies
  • The perspective of Academic Centers: Meletios Dimopoulos, Professor of Hematology-Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens
  • Decentralized clinical trials (or elements in clinical trials): Christos Lionis, Professor Emeritus of General Practice and Primary Health Care, School of Medicine, University of Crete
  • Pharma perspective: Rob DiCicco, Vice President Portfolio Management, TranCelerate BioPharma 
  • Vulcan UDP Project – Utilizing the Digital Protocol: Hugh Glover, Vulcan Technical Director