8 Episodes|15 Minutes | Friday Mornings 

The GCP E6 (R3) Morning Show – Webinar Series

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Episode Guide 

The GCP E6 (R3) Morning Show |Webinar Series 

📅 Episode 1: Season Kickoff – Why Update Now?


Date: 2025-02-21 | 08:45-09:00
 
  • What’s the purpose of the ICH E6(R3) update?
  • Why introduce this revision so soon after E6(R2) in 2016?
  • The current timeline and status of E6(R3).
Join Torbjörn, Anna-Karin, and Beatrice as they set the stage for the season!

Speakers

Torbjörn Ström

Clinical Project Manager

Anna-Karin Abelson

Clinical Research Manager

Beatrice Öström

Executive Vice President Pre-Clinical & Clinical Development

📅 Episode 2: E8(R1) – Building the Foundation

 
Date: 2025-02-28 | 08:45-09:00
 
  • General considerations for designing and conducting clinical studies.
  • How E8(R1) principles connect to E6(R3).
  • What structural and terminological changes should you watch for?
Learn from Charlotta, Emma, Beatrice as they navigate these foundational aspects.

Speakers

Charlotta Björk

Clinical Project Manager

Emma Perlhamre

Head of Clinical Development

Daniel Strömblad

Head of Clinical Operations

📅 Episode 3: Investigator Responsibilities – What’s Changing?


Date: 2025-03-07 | 08:45-09:00
 
  • Significant revisions in the Investigator section: What’s been added, removed, or restructured?
  • Key responsibilities, informed consent updates, and data system management.
Join Åsa, Sofia, and Daniel for a deep dive into these crucial updates.

Speakers

Åsa Nilsson

Clinical Research Manager

Sofia Henriksson

Clinical Project Manager

Daniel Strömblad

Head of Clinical Operations

📅 Episode 4: Sponsor – Risk and Oversight Redefined


Date: 2025-03-14 | 08:45-09:00
 
  • Extensive revisions to the Sponsor section, including stakeholder input.
  • New approaches to oversight, quality, and risk management.
  • What’s changing in safety assessment and reporting?
Insights from Charlotta, Torbjörn, and Beatrice will guide this discussion.

Speakers

Charlotta Björk

Clinical Project Manager

Torbjörn Ström

Clinical Project Manager

Beatrice Öström

Executive Vice President Pre-Clinical & Clinical Development

📅 Episode 5: Sponsor – Monitoring, Data, & IMPs


Date: 2025-03-21 | 08:45-09:00
 
  • Updates on monitoring and data handling responsibilities.
  • Managing Investigational Medicinal Products (IMP).
  • How do these changes enhance study quality?
Learn from Anna-Karin, Alexander and Daniel about these pivotal updates.

Speakers

Anna-Karin Abelson

Clinical Research Manager

Alexander Moore

Clinical supply manager/Clinical trial associate

Daniel Strömblad

Head of Clinical Operations

📅 Episode 6: Data Governance – The Backbone of Compliance


Date: 2025-03-28 | 08:45-09:00
 
  • Data Governance and Data Integrity.
  • Key processes to address the full data life cycle.
  • Best practices for ensuring compliance under E6(R3).
Join Louise, Emma, Beatrice for this focused discussion.

Speakers

Louise Kvistgaard

Sr. QA Consultant (GCP)

Emma Perlhamre

Head of Clinical Development

Beatrice Öström

Executive Vice President Pre-Clinical & Clinical Development

📅 Episode 7: TMF – What’s New?


Date: 2025-04-04 | 08:45-09:00

  • Updates to Trial Master File requirements: What’s new in E6(R3)?
  • Comparing R2/R3 to the CDISC TMF Reference Model.
Explore these changes with Lihn, Pernilla, and Daniel as they share their expertise.

Speakers

Lihn Fabian-Bui

Clinical Trial Assistant

Pernilla Lindelöv

Clinical Project Manager

Daniel Strömblad

Head of Clinical Operations

📅 Episode 8: Season Finale – E6(R3) Summary and Next Steps


Date: 2025-04-11 | 08:45-09:00
 
  • Wrap-up of E6(R3) changes
  • Key takeaways: What will impact our ways of working the most?
  • Preparing for the future: Next steps?
Beatrice, Charlotta, Emma, Anna-Karin, Torbjörn and Daniel will close out the season.

Beatrice Öström

Executive Vice President Pre-Clinical & Clinical Development

Charlotta Björk

Clinical Project Manager

Emma Perlhamre

Head of Clinical Development

Anna-Karin Abelson

Clinical Research Manager

Torbjörn Ström

Clinical Project Manager

Daniel Strömblad

Head of Clinical Operations

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