Loading…
2nd ICH E6(R3) has ended
Simple
Expanded
Grid
By Venue
Thursday, September 5
 

10:00am EDT

Welcome and Introduction
Thursday September 5, 2024 10:00am - 10:15am EDT
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
avatar for Dave Nickerson

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
avatar for Paula Walker

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 - 11:45am EDT
Speakers
avatar for Dave Nickerson

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 →
avatar for Paula Walker

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 11:15am - 11:45am EDT
  Must attend LIVE (Not Recorded)

11:45am EDT

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

12:15pm EDT

DATA GOVERNANCE
Thursday September 5, 2024 12:15pm - 1:00pm EDT
Examine the 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
Speakers
avatar for Janette Panhuis

Janette Panhuis

Principal Consultant, Quality Matters
Thursday September 5, 2024 12:15pm - 1:00pm EDT
  Available On-Demand - Must Participate LIVE to Engage with Speakers

1:00pm EDT

ESSENTIAL RECORDS AND TMF
Thursday September 5, 2024 1:00pm - 1:45pm EDT
Regulators have long supported quality by design and risk-based approaches for clinical trials, but adoption has been slow. This session explores opportunities and barriers to implementing risk-based record filing with the ICH GCP E6(R3) update.

Key Benefits of Attending This Session:

  • Learn about the regulatory acceptance of quality by design and risk-based approaches
  • Discuss the challenges that have hindered the adoption of risk-based filing of records
  • Examine the potential benefits and opportunities for adopting these practices in your TMF management
  • Receive practical advice on how to develop a sound rationale for your approach to TMF management
Speakers
avatar for Louise Mawer

Louise Mawer

GXP Auditor and Trainer, Mirabilitas Ltd
Thursday September 5, 2024 1:00pm - 1:45pm EDT
  Available On-Demand - Must Participate LIVE to Engage with Speakers

1:45pm EDT

15-Minute Break
Thursday September 5, 2024 1:45pm - 2:00pm EDT
Thursday September 5, 2024 1:45pm - 2:00pm EDT

2:00pm EDT

SPONSOR OVERSIGHT
Thursday September 5, 2024 2:00pm - 2:45pm 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
Speakers
avatar for Cheryl McCarthy, RQAP-GCP, CQA, CMDA.

Cheryl McCarthy, RQAP-GCP, CQA, CMDA.

Experienced GCP/Quality Professional
Thursday September 5, 2024 2:00pm - 2:45pm EDT
  Available On-Demand - Must Participate LIVE to Engage with Speakers

2:45pm EDT

CONCLUDING PANEL: HOW TO PREPARE
Thursday September 5, 2024 2:45pm - 3:45pm 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
Speakers
avatar for Michele Weitz

Michele Weitz

Principal, GCP Vision
avatar for Louise Mawer

Louise Mawer

GXP Auditor and Trainer, Mirabilitas Ltd
avatar for Cheryl McCarthy, RQAP-GCP, CQA, CMDA.

Cheryl McCarthy, RQAP-GCP, CQA, CMDA.

Experienced GCP/Quality Professional
Thursday September 5, 2024 2:45pm - 3:45pm EDT
  Available On-Demand - Must Participate LIVE to Engage with Speakers

3:45pm EDT

Event Concludes
Thursday September 5, 2024 3:45pm - 3:45pm EDT
Thursday September 5, 2024 3:45pm - 3:45pm EDT
 
  • Filter By Type
    Available On-Demand - Must Participate LIVE to Engage with Speakers
    Must attend LIVE (Not Recorded)
  • Timezone
Share Modal

Share this link via

Or copy link

Filter sessions
Apply filters to sessions.
Thursday, September 5
  • Available On-Demand - Must Participate LIVE to Engage with Speakers
  • Must attend LIVE (Not Recorded)