2nd ICH E6(R3): Full Schedule

10:00am EDT

Welcome and Introduction

Thursday September 5, 2024 10:00am - 10:15am EDT

Available On-Demand - Must Participate LIVE to Engage with Speakers

10:15am EDT

THE PURPOSE OF ICH E6 REVISIONS AND UPDATE ON FINALIZATION

Thursday September 5, 2024 10:15am - 10:45am EDT

THE PURPOSE OF ICH E6 REVISIONS AND UPDATE ON FINALIZATION
Learn From an R3 Working Group Member on the Reason for the Revisions as Well as an Update on Finalization and Adoption

Examine the drivers behind these changes
Describe the principles that guided the creation of R3
Overview of the key areas of change
Understand the forecasted timelines for finalization and adoption

Speakers

Dave Nickerson

Head, Clinical Quality Management, EMD SERONO; Member of E6(R3) Expert Working Group

David Nickerson joined EMD Serono (Merck KGaA, Darmstadt, Germany) in 2016 as the Head of Clinical Quality Management in Global Development Operations. In this role he has global responsibility for the strategy, implementation, oversight, and improvement of risk-based approaches to... Read More →

Thursday September 5, 2024 10:15am - 10:45am EDT

Available On-Demand - Must Participate LIVE to Engage with Speakers

10:45am EDT

PROPORTIONATE RISK-BASED APPROACH

Thursday September 5, 2024 10:45am - 11:15am EDT

PROPORTIONATE RISK-BASED APPROACH
Evaluate the Addition of the Term “Proportionate” and Understand the Meaning as it Relates to Different Aspects of the Trial

Use critical to quality factors to determine high risk areas
Understand the proportionate approach to training
Focus quality management on processes and data that are critical to quality to execute a proportionate and risk-based approach

Speakers

Paula Walker

Global Head Risk Based Management, ROCHE; Former Head of Compliance, MHRA

My primary focus is ensuring our work maintains the patient at the centre of every decision we make. This is central to implementation of Risk Based Quality Management, ensuring we are focusing on what matters to demonstrate reliability of data. Over the last year I established a... Read More →

Thursday September 5, 2024 10:45am - 11:15am EDT

Available On-Demand - Must Participate LIVE to Engage with Speakers

11:15am EDT

SPEAKER Q&A: FACE-TO-FACE ENGAGEMENT VIA ZOOM

Thursday September 5, 2024 11:15am - 11:30am EDT

Speakers

Dave Nickerson

Head, Clinical Quality Management, EMD SERONO; Member of E6(R3) Expert Working Group

Paula Walker

Global Head Risk Based Management, ROCHE; Former Head of Compliance, MHRA

Thursday September 5, 2024 11:15am - 11:30am EDT

Must attend LIVE (Not Recorded)

11:30am EDT

15-Minute Break

Thursday September 5, 2024 11:30am - 11:45am EDT

11:45am EDT

DATA GOVERNANCE

Thursday September 5, 2024 11:45am - 12:15pm EDT

Examine the Significant Expansion of Sponsor Responsibilities Related to Clinical Data Governance and Data Quality

Discuss the sponsor’s responsibility to define the required data quality
Understand the regulatory expectations and the sponsor’s partnership with investigator(s)
Outline considerations for maintaining integrity for blinded studies
Review guidance for the phases of the data lifecycle and supporting attributes like metadata and audit trails
Outline finalization steps to prepare for study analysis

Thursday September 5, 2024 11:45am - 12:15pm EDT

Available On-Demand - Must Participate LIVE to Engage with Speakers

12:15pm EDT

COMPUTERIZED SYSTEMS

Thursday September 5, 2024 12:15pm - 12:45pm EDT

Illustrate the Changes Pertaining to the Development and Validation of Clinical Systems

Define the purpose of each system as it relates to the specific clinical trial and who as responsibility
Develop clinical systems for GCP requirements, no more repurposing non-clinical systems
Solicit input from patients, HCPs and all end-users on system design
Evaluate new expectations on user management and security
Examine changes in the timeframe for system validation

Thursday September 5, 2024 12:15pm - 12:45pm EDT

Available On-Demand - Must Participate LIVE to Engage with Speakers

12:45pm EDT

ESSENTIAL RECORDS AND TMF

Thursday September 5, 2024 12:45pm - 1:15pm EDT

Review the Updated Definition for Essential Records and Where/How they are Maintained and Managed

Recognize the change in language from essential documents, to essential records
Understand the definition of essential records
Review updated management guidelines for essential records
Outline differences between R2 and R3 as they relate to the TMF

Thursday September 5, 2024 12:45pm - 1:15pm EDT

Available On-Demand - Must Participate LIVE to Engage with Speakers

1:15pm EDT

SPEAKER Q&A: FACE-TO-FACE ENGAGEMENT VIA ZOOM

Thursday September 5, 2024 1:15pm - 1:30pm EDT

Must attend LIVE (Not Recorded)

1:30pm EDT

30-Minute Break

Thursday September 5, 2024 1:30pm - 2:00pm EDT

2:00pm EDT

SPONSOR OVERSIGHT

Thursday September 5, 2024 2:00pm - 2:30pm EDT

Discuss Oversight Measures that are Fit for Purpose and Related to Trial Risks, as Outlined in R3

Discuss the expansion of the sponsor’s responsibility for delegated activities
Recognize the expanded term of Service Provider and no longer CRO only
Evaluate new requirements for sponsors to qualify clinical service providers
Understand when documented agreements with service providers must be in place and updating requirements
Identify updates related to issue escalation

Thursday September 5, 2024 2:00pm - 2:30pm EDT

Available On-Demand - Must Participate LIVE to Engage with Speakers

2:30pm EDT

MONITORING

Thursday September 5, 2024 2:30pm - 3:00pm EDT

Describe How this Section Has Evolved to a More Modern Monitoring Approach

Examine updated investigator site monitoring, including remote
Understand the updates related to centralized monitoring as a key part of a risk-based approach
Outline updates to the monitoring plan
Discuss new sponsor procedure requirements for monitoring reports

Thursday September 5, 2024 2:30pm - 3:00pm EDT

Available On-Demand - Must Participate LIVE to Engage with Speakers

3:00pm EDT

SPEAKER Q&A: FACE-TO-FACE ENGAGEMENT VIA ZOOM

Thursday September 5, 2024 3:00pm - 3:15pm EDT

Must attend LIVE (Not Recorded)

3:15pm EDT

CONCLUDING PANEL: HOW TO PREPARE

Thursday September 5, 2024 3:15pm - 4:00pm EDT

Learn How Different Companies are Translating this Guidance into Early Actions to Ready for Regulatory Adoption

Analyze what industry leaders are viewing as the most impactful elements of the guidance
Identify what early actions are being taken to build the framework for compliance
Hear recommendations for how to prioritize actions at your company

Thursday September 5, 2024 3:15pm - 4:00pm EDT

Available On-Demand - Must Participate LIVE to Engage with Speakers

4:00pm EDT

Event Concludes

Thursday September 5, 2024 4:00pm - 4:00pm EDT