Data Integrity for Clinical Research Summit -

Data Integrity for Clinical Research Summit
May 22 - 23, 2017
Morristown, NJ

The Data Integrity for Clinical Research Summit will showcase how to develop all standard procedures for information from inspection to completion

Agenda – Data Integrity for Clinical Research Summit



Day One

 Monday May 22, 2017

8:45AM – 9:00AM

Chairperson’s Introduction


Leslie Sam, Director, Global Quality Systems, Safety, Efficacy and Customer Information, ELI LILLY AND COMPANY

9:00AM – 9:45AM

Data Integrity, Data Quality and Regulatory Guidance: Perspectives on Clinical Studies for ANDA


Shrinivas Savale, Principal Consultant, GANNET PHARMA SOLUTIONS, INDIA

9:45AM – 10:30AM

IMC Perspective on Data Integrity


Allan Wilson, President, INFORMATION MEDIARY CORPORATION (IMC)

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

Panel: The New Draft MHRA GxP Data Integrity Definitions and Guidance for Industry


Ana Sharma, Global Head, Strategy and Operations for Clinical Development Quality, NOVARTIS
Bodo Lutz, Global Clinical Quality Assurance, Compliance and Data Integrity Officer, NOVARTIS

11:45AM – 12:30PM

Panel: Plan for Prevention and Check for Data Integrity in Your Organization


Kerrick Wilson, Quality Assurance Manager, GLAXOSMITHKLINE
Jim Myers, Executive Director Quality Assurance and Compliance, Ionis Pharmaceuticals

12:30PM – 1:30PM

Luncheon


1:30AM – 2:15PM

ALCOA: A Company’s Perspective on How to Ensure Better Data Integrity Overall


Angel Amaya, Senior Clinical Research Associate, NOVARTIS

2:15PM – 3:00PM

Panel: Prevention to Design Out the Risks


Panel:
David Fryrear, Senior Director, Clinical and Pharmacovigilance QA, ABBVIE
Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY

3:00PM – 3:30PM

Networking Break


3:30PM – 4:15PM

Panel: Risk Management Procedures and Processes


Paige Goodlove, Consultant, ELI LILLY AND COMPANY
Jim Myers, Executive Director Quality Assurance and Compliance, Ionis Pharmaceuticals
David Fryrear, Senior Director, Clinical and Pharmacovigilance QA, ABBVIE

4:15PM – 5:00PM

Case Study: Implement Electronic Controls in Laboratories to Ensure Data Integrity


John Hannon, Global Business Lead, Automation and IT, Commissioning Agents, Inc.

5:00PM – 5:45PM

J&J Case Study: Extraction, Transformation and Integration of Streaming Data for the Digital Patient and Consumer


Robert J. Boland, Associate Director, Emerging Science and Innovation Strategy, JOHNSON & JOHNSON


Day Two

 Tuesday May 23, 2017

8:00AM – 8:45AM

Continental Breakfast


8:45AM – 9:00AM

Chairperson’s Recap of Day One


Leslie Sam, Director, Global Quality Systems, Safety, Efficacy and Customer Information, ELI LILLY AND COMPANY

9:00AM – 9:45AM

Endgame Quality Control: Delivering on the Promise of Integrity


Anna Capaldi, Quality Control Submission Lead Biosimilars, PFIZER

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

A Sponsor’s Perspective on Data Integrity


Bodo Lutz, Global Clinical Quality Assurance, Compliance and Data Integrity Officer, NOVARTIS

11:45AM – 12:30PM

Data Integrity in Clinical Research


Barbara Skinn, Operations Portfolio Lead, Global Clinical Operations, BRISTOL-MYERS SQUIBB
Molly Rodgers, Senior Immuno-Oncology Data Lead, BRISTOL-MYERS SQUIBB

12:30PM – 1:30PM

Luncheon


1:30PM – 2:15PM

Clinical Trial Data Transparency from Site to Sponsor


Debra Mayo, Vice President, Global Scientific Communications, TEVA

2:15PM – 3:00PM

Keynote Presentation: It’s My Data and I’ll Share if I Want To


Greg Koski, President and Co-Founder, ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES)

3:00PM – 3:30PM

Networking Break


3:30PM – 4:15PM

Enabling Near-Time Analysis of Exploratory Biomarker Data in Clinical Studies


Irene Pak, Associate Director, Disease Area Information Science, BRISTOL-MYERS SQUIBB

4:15PM – 5:00PM

Clinical Data Sharing for Translational Medicine: An Informatics Approach


Raj Bandaru, Senior Director, Data Sciences Strategy, SANOFI


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