MONDAY, APRIL 6 | 2:30 - 5:30 PM
Workshop 2: Digital Clinical Development: Tutorial, Case Studies, and Future Readiness - Detailed Agenda
Instructors: Munther Baara, Vice President, Product Strategy and Innovation, EDETEK, Inc.
Craig Lipset, Independent Adviser, Former Head of Clinical Innovation, Pfizer
Participants in this workshop will understand the role of digital in impacting end-to-end clinical development inclusive of recruitment, engagement, ongoing data collection, and the predictive models to reduce the research cycle time, reduce the number
of participants and lowers the cost of bringing medicine to market.
Workshop 3: Inspection Readiness in Changing Global Regulatory Environment
Instructors: Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
Julia Martinisi, Project Director, Clinical Operations Consultant, JM Pharma Consulting
The ICH revised E6 guidelines was issued to reflect on the current research landscape: increases in globalization, study complexity, and technological capabilities. The updated ICH GCP E6 R2 is more descriptive than the previous version and describes
26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined
and implemented; introducing Risk-Based Quality Management; serious breaches, and, a new section on computer validation and electronic records, to name a few. This workshop is designed to help quality assurance and compliance specialists, study monitors,
and auditors meet these challenges proactively, with the goal of strengthening auditing programs and ensuring compliance with risk-based techniques in preparation to FDA inspection.
*Workshops are included in your registration. However, please RSVP to reserve your seat.