Training Seminar

Risk-Based Quality Management for Clinical Trials: Implementing ICH E6 R3 Requirements

February 6-7, 2025

Thursday, February 6 | 2:00 – 5:00 pm ET
Friday, February 7 | 9:00 am – 4:30 pm ET

Are you prepared for Quality Risk Management (QRM), Risk Management (RM), and Risk-Based Quality Management (RBQM)? With ICH GCP E6 R3 in the final stage, the guideline still requires risk-based approaches to managing quality in clinical trials and this 1.5-day course takes you through, step-by-step, how to execute these requirements. We will focus on the critical elements for clinical trial sponsors and CROs included in the ICH GCP E6 R3 expectations while highlighting key points from other regulatory bodies such as ISO 31000 Risk Management. Each step of risk identification, assessment, control, review, reporting, management, and communication are also reviewed along with what is to be documented in the clinical study report.

Training seminar delivered by:

Susan M. Leister, MBA, PhD, CQA, CSSBB, Vice President, Quality & Compliance, Technical Resources International, Inc.; Senior Trainer, Barnett International

SCOPE Summit Europe

2025 Conference Programs

◆ Sunday Golf, Kick-Off Keynote & Participant Engagement Award

◆SCOPE’s Kickoff Reception

◆Pre-Con User Group & Workshops

◆ Patient Voice in Trial Design and Protocol Development

◆ Developing and Executing Effective Diversity Plans

◆ Data-Informed Feasibility and Investigator Selection

◆ Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

◆ Enrollment Planning and Patient Recruitment

◆ Patient Engagement and Retention through Communities and Technology

◆ (NEW) Collaborative Strategies to Improve Trial Execution

◆ Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

◆ Clinical Trial Forecasting, Budgeting and Contracting

◆ Resource Management and Capacity Planning for Clinical Trials

◆ Mastering an Outsourcing Strategy

◆ Relationship and Alliance Management in Outsourced Clinical Trials

◆ Partner Selection and Trial Design

◆ Vendor Oversight & Resource Management

◆ Clinical Data Strategy and Analytics

◆ Data Science, ML, and AI

◆ Decentralized and Hybrid Trials

◆ DCTs and Clinical Innovation

◆ Digital Biomarkers and Endpoints in Clinical Trials

◆ Digital Measurements Implementation at Scale

◆ Accessing and Generating RWD

◆ Leveraging RWD for Clinical Research

◆ (NEW) Generative AI in Clinical Research

◆ (NEW) AI for Trial Optimization

◆ Risk-Based Quality Management

◆ Central and Remote Monitoring

◆ Modernizing Lab, Biomarker & Data Management Operations

◆ Biomarker & Biospecimen Technology & Innovation

◆ Data Technology for End-to-End Clinical Supply Management

◆ Clinical Supply Chain Strategies to Align Process, Products and Patients

◆ Clinical Trial Venture, Innovation & Partnering *
*Separate Registration Required