Quality Discussion: Do we need to slow down to speed up? Leveraging ICH E6 (R3) to drive efficiency in the clinical trial process
Wednesday, May 15, 2024, 11:15 AM - 12:00 PM
ICH E6 (R3) highlights the need for thoughtful study design, careful assessment of critical to quality factors, and implementation of risk-proportionate approaches. This takes time, usually at the beginning of the study, where the impulse is to move fast. If we put our attention on the factors that really matter, can we leverage the expectations in ICH E6 (R3) to drive efficiency without impacting quality? In this session, clinical research thought leaders will share insights and opportunities.
• Karen Harvey - Senior Director, Avoca Quality Consortium - Avoca, A WCG Company (Facilitator)
• Rachel Lara - Vice President, Regional Operational Delivery, Americas, Clinical Operations - PPD, part of Thermo Fisher Scientific (Panelist)
• Joshua Petersen - Director of Quality Assurance - Velocity Clinical Research (Panelist)
• Hanne Storgaard Schultz - Regional Director, Clinical Quality Management EMEA (RCQM EMEA 4) | Quality & Continuous Improvement (QCI) - Global Clinical Trial Operations (GCTO) - MSD (Panelist)
• Alethea Wilson - Director, Risk & Analytics Lead | Risk Evaluation & Adaptive Integrated Monitoring (REAIM) | Quality & Continuous Improvement | Global Clinical Trial Operations (GCTO) - Merck (Panelist)
• Rachel Lara - Vice President, Regional Operational Delivery, Americas, Clinical Operations - PPD, part of Thermo Fisher Scientific (Panelist)
• Joshua Petersen - Director of Quality Assurance - Velocity Clinical Research (Panelist)
• Hanne Storgaard Schultz - Regional Director, Clinical Quality Management EMEA (RCQM EMEA 4) | Quality & Continuous Improvement (QCI) - Global Clinical Trial Operations (GCTO) - MSD (Panelist)
• Alethea Wilson - Director, Risk & Analytics Lead | Risk Evaluation & Adaptive Integrated Monitoring (REAIM) | Quality & Continuous Improvement | Global Clinical Trial Operations (GCTO) - Merck (Panelist)