Agenda – The 2nd Data Integrity & Protection For Clinical Research Summit

  • Day One
  • Day Two

Day One

 Thursday, 7 December

9:00 – 9:15

Chairperson's Opening Remarks
Elke Ufer, Quality Manager Compliance, Clinical Operations (GI-DD-CO), GRUNENTHAL GMBH

9:15 – 11:00

INTERACTIVE WORKSHOP: Guide to Data Integrity
Bernice Kuca, Head Clinical Operations, COLUCID PHARMACEUTICALS

11:00 – 11:30

Networking Break

11:30 – 12:15

Evolving Expectations for Data Integrity
Patricia Pengelly, Associate Director Clinical QA, ABBVIE

12:15 – 13:00

Electronic Archiving From a Regulatory and Business Perspective
Eldin Rammell, Managing Director, RAMMELL CONSULTING

13:00 – 14:00

Luncheon

14:00 – 14:45

Understand How to Build Data Integrity Into the Culture of the Company
James Mann, Head Data Integrity Programme Management, NOVARTIS

14:45 – 15:30

Impact on Data Integrity — A Practical Perspective
Elke Ufer, Quality Manager Compliance, Clinical Operations (GI-DD-CO), GRUNENTHAL GmbH

15:30 – 16:00

Networking Break

16:00 – 16:45

Understand How to Maintain Audit Trails and How to Manage Audit Trails Electronic Signatures
Angel Amaya, Senior Clinical Research Associate, NOVARTIS

16:45 – 17:30

Best Practices to Implement a Risk-Based Approach for Ensuring Data Integrity
Bhaswat Chakraborty, Senior VP and Chair, Research and Development, CADILA PHARMACEUTICALS


Day Two

 Friday, 8 December

8:45 – 9:30

Chairperson's Recap of Day One
Elke Ufer, Quality Manager Compliance, Clinical Operations (GI-DD-CO), GRUNENTHAL GMBH

9:30 – 10:15

Ensuring Data Integrity in a Cloud Environment
Sigrid Guhr, GMP QA Qualification & Validation, ABBVIE

10:15 – 11:00

Panel: Demonstration of Data Integrity
Eldin Rammell, Managing Director, RAMMELL CONSULTING
Bhaswat Chakraborty, Senior VP and Chair, Research and Development, CADILA PHARMACEUTICALS
Daniel Hickmore, VP of Health and Life Sciences, ARKIVUM

11:00 – 11:30

Networking Break

11:30 – 12:15

Strategies and Solutions for Ensuring Data Integrity in Clinical Research for Academic
Kristen Bolt, Former Programme Manager, Data Sharing and Transparency, MULTI-REGIONAL CLINICAL TRIALS CENTRE OF BRIGHAM AND WOMEN’S HOSPITAL AND HARVARD

12:15 – 13:15

Luncheon

13:15 – 14:00

Computer System Validation/Software Development Life Cycle
Sigrid Guhr, GMP QA Qualification and Validation, ABBVIE

14:00 – 14:45

Compliance System Validation for Electronic Tools
Oliver Herrmann, Member of the D.I.G.I.T. Committee, RESEARCH QUALITY ASSOCIATION (RQA) PHARMACEUTICALS