New York Professional Events List


Data Integrity for Clinical Research Summit


Date
May 22, 2017 - 08:00 AM - May 23, 05:15 PM
Organizer
exlevents
Location
Hyatt Regency Morristown Hyatt Regency Morristown 3 Speedwell Avenue Morristown, NJ 07960,

Morristown,
NJ ,
US,
ZIP: 07960
Phone: +1 929 900 1853

Data Integrity for Clinical Research Summit -

Data Integrity for Clinical Research Summit

Data can come into an organization through many avenues, but it’s important to understand where the data came from, its level of quality and its role in reporting clinical research. This is especially true for a clinical trial, where you need to safeguard the integrity of data from its inception to archival. Achieving and maintaining data integrity ensures the results of clinical trials are based on high-quality data, which helps determine the outcomes of these clinical trials.

The Data Integrity for Clinical Research Summit will showcase the most important trends and future direction of clinical data integrity. This program will feature case studies and panel sessions, and will uncover data integrity successes and challenges.

Top Five Reasons to Attend

  1. Understand the implications of data integrity and the risks to your organization
  2. Discuss the management of data quality using a risk-based approach to detect risks
  3. Hear from pharmaceutical companies that have successfully ensured data integrity in clinical trials
  4. Master how to plan and check for data integrity
  5. Manage the complete life cycle of data by establishing procedures and best practices

Who Should Attend

This event is ideal for professionals with responsibilities in the following areas:

  • Data Integrity
  • Clinical Quality/Data
  • Clinical Operations
  • Clinical Research
  • Paper Monitoring
  • Quality Assurance/Quality Control
  • Document/Data Management
  • IT
  • Validation
  • Compliance
  • Quality Risk Management
  • Regulatory Affairs
  • Auditing

The event is also relevant to clinical QA, compliance and operations professionals from:

  • Quality Service Providers and Consulting Companies
  • CROs
  • Data Management and Software Vendors
  • Safety Reporting Vendors

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Please contact the event manager Marilyn below for the following:
 
- For Tickets/Registrations,
- Discounts for registering  5 or more participants.
- If you company requires a price quotation.
 
Event Manager Contact:


marilyn.b.turner(at)nyeventslist.com or Contact:  +1 929 900 1853
 
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
 
NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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This Event Listing is Promoted by  New York Media Technologies LLC in association
with EXL Events Inc.

 
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Agenda


Day One
Monday May 22, 2017

8:00AM – 8:45AM Registration and Continental Breakfast

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

5:45PM –
Conclusion of Day One
 

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

9:45AM – 10:30AM
CLINICAL DATA INTEGRITY Optimizing Data Integrity by Ensuring Compliant Documentation of All Data Entries and Changes

Nathalie Bourgouin, PMP, Director, SKILLPAD

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

5:00PM –
Conference Concludes
 
 


Speaker Details


Featured Speakers


Event Categories
COMPUTERS AND INTERNET CONFERENCES
,
HEALTH AND MEDICINE CONFERENCES
,
Healthcare
,
Life Sciences, Biotechnology
,
Technology
Keywords: fun, Clinical , Fun , Management , pharmaceutical , professional, program , purchase, research , sho




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