£1,559.95 – £4,659.95

2nd Data Integrity & Protection for Clinical Research Summit (EXL)

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Location

Hilton London Kensington

179-199 Holland Park Avenue

London

W11 4UL

United Kingdom

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Refund Policy

Refund Policy

No Refunds

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Event description

Description

2nd Data Integrity & Protection for Clinical Research Summit

Data Integrity continues to be a primary goal of clinical research conducted by life science companies. Data can come in an organization in many avenues and is important that any data that is generated for any clinical trial needs to be valid, sufficient and of the highest quality. Procedures and processes have been implemented to advance data integrity to make successful outcomes in clinical trials. Learn from your clinical research professionals who will provide an overview of data integrity strategies, benefits, and challenges.

The 2nd Data Integrity & Protection for Clinical Research Summit will showcase how to ensure the integrity of data from its inception to archival and how to improve the quality and efficiency of data integrity in clinical trials. This program will feature case studies, panel sessions, approaches companies are taking to master the integrity of data, and how to improve the cross-functional responsibilities to ensure clinical research.


Featured Speakers:


Bernice Kuca,
Head Clinical Operations,
COLUCID
PHARMACEUTICALS


James Mann,
Head Data Integrity Programme Management,
NOVARTIS



Eldin Rammell,
Managing Director,
RAMMELL CONSULTING


Siobhan Hurley,
Clinical QA Programme Manager R&D Quality Assurance,
ABBVIE



Bhaswat Chakraborty,
Senior VP and Chair, Research and Development,
CADILA PHARMACEUTICALS


Top Five Reasons to Attend

  1. Hear from pharmaceutical companies that found solutions and successfully ensured data integrity in clinical trials
  2. Master data integrity metrics, bench marketing, and implementations to ensure data integrity in clinical trials
  3. Review MHRA, FDA, and EMA inspection findings
  4. Understand regulatory guidances and relationships with data quality and data integrity
  5. Discuss the management of data quality using a risk-based approach to detect risks

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/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


Agenda

Day One

Thursday, 7 December

8:00 – 9:00

Registration and Continental Breakfast

9:00 – 9:15

Chairpersons’ Opening Remarks

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

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

12:15 – 13:00

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

13:00 – 14:00

Luncheon

14:00 – 14:45

Understand the ICH E6 R2 and the Quality Objectives of Clinical Research With Data Reliability
Heather Kato, Associate Director, Clinical Operations and Clinical Quality, XENON PHARMACEUTICALS

14:45 – 15:45

Evolving Expectations for Data Integrity
Siobhan Hurley, Clinical QA Programme Manager R&D Quality Assurance, ABBVIE

15:45 – 16:15

Networking Break

16:15 – 17:00

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

17:00 – 17:45

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

17:45 – Day One Concludes


Day Two

Friday, 8 December

8:00 – 8:45

Continental Breakfast

8:45 – 9:00

Co-Chairpersons’ Recap of Day One

9:00 – 9:45

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

9:45 – 10:30

Panel: Demonstration of Data Integrity
Eldin Rammell, Managing Director, RAMMELL CONSULTING
Bhaswat Chakraborty, Senior VP and Chair, Research and Development, CADILA PHARMACEUTICALS

10:30 – 11:15

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

11:15 – 11:45

Networking Break

11:45 – 12:15

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

12:15 – 13:00

Panel: Explore Data From Different Sites in Paper and Electronic Formats
Siobhan Hurley, Clinical QA Programme Manager R&D Quality Assurance, ABBVIE
James Mann, Head Data Integrity Programme Management, NOVARTIS

13:00 – 14:00

Luncheon

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

14:45 – 15:30

Technology Perspective on Data Integrity

15:30 –

Conference Concludes


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Faculty
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Angel Amaya
Senior Clinical Research Associate, NOVARTIS



Kristen Bolt
Former Programme Manager, Data Sharing and Transparency, MULTI-REGIONAL CLINICAL TRIALS CENTRE OF BRIGHAM AND WOMEN’S HOSPITAL AND HARVARD



Bhaswat Chakraborty
Senior VP and Chair, Research and Development, CADILA PHARMACEUTICALS




Sigrid Guhr
GMP QA Qualification and Validation, ABBVIE



Oliver Herrmann
Member of the D.I.G.I.T. Committee, RESEARCH QUALITY ASSOCIATION (RQA) PHARMACEUTICALS




Daniel Hickmore
VP of Health and Life Sciences, ARKIVUM



Siobhan Hurley
Clinical QA Programme Manager R&D, Quality Assurance, ABBVIE



Bernice Kuca
Head Clinical Operations, COLUCID PHARMACEUTICALS



James Mann
Head Data Integrity Programme Management, NOVARTIS



Eldin Rammell
Managing Director, RAMMELL CONSULTING



Elke Ufer
Quality Manager Compliance, Clinical Operations (GI-DD-CO), GRÜNENTHAL GMBH




Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
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 ALLOWED ON REGISTRATIONS
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Date and Time

Location

Hilton London Kensington

179-199 Holland Park Avenue

London

W11 4UL

United Kingdom

View Map

Refund Policy

No Refunds

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