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ISPE/DIA Workshop on Computer Systems Compliance “Maintain Data Integrity to Reduce Risk for the Patient”

Nov 6 2014 8:00AM - Nov 7 2014 5:30PM | Pullman Basel Europe Clarastrasse 43 4058 Basel Switzerland

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Data integrity surrounding computerised system supported business processes throughout the product life cycle has been at the forefront of recent news, for example Ranbaxy in the USA. The awareness of these issues has changed the approach used by both EU and US regulators in conducting inspections in recent years. As data integrity increasingly becomes a focus of the regulatory authorities, the industry has to recognise and ensure controls for data integrity are implemented and appropriately managed throughout the entire life cycle of the data. Problems with data integrity manifest themselves differently in each phase of the life cycle. Therefore improvements must be managed differently during each phase, based on business risk.

This 2-day conference will provide a forum for information, discussion on conceptual and practical questions and experience exchange through lectures, panel discussions, and interactive workshop sessions. It will focus on the work being conducted by two leading organisations within the life sciences sector who approach the subject from differing directions but with the same clear objective of ensuring data integrity to reduce the risk to the patient. It will focus on the well-established approaches used, identifying the similarities of key principles and practice, and the challenges facing the industry with the availability of new technologies such as cloud computing.

Featured Topics 

  • The regulatory perspectives on data integrity and the use of new technologies
  • The principles of GAMP® 5 and its relationship to Clinical systems
  • Understanding Business Process Risk Management
  • Maintaining data integrity
  • The challenges to the industry and regulators of emerging computing strategies like the use of mobile and cloud-based platforms

Who Should Attend 

This conference is aimed at intermediate and experienced professionals from:

  • The pharmaceutical industry and Contract Research Organisations including:
  • Staff from clinical science and clinical operations
  • Monitors, auditors of clinical trials
  • Regulatory affairs personnel
  • Information Technology and CSV practitioners
  • Research and clinical quality assurance staff
  • Regulatory agencies
  • IT service provider organisations
  • Academic institutions
  • GXP compliance professionals

Learning Objectives 

Participants will:

  • Gain an awareness of the principles of the GAMP® 5 risk-based approach to compliant GxP computerised systems and how they support the maintenance of data integrity.
  • Understand the principle regulatory concerns and how they may be addressed.
  • Discuss and identify the key challenges and opportunities of the new technology.
  • Recognise how companies and industry organisations are developing principles and practical advice to meet these challenges to data integrity throughout the entire product life cycle.
  • Have the opportunity to exchange views between regulators, industry and other stakeholders.

Hotel & Travel 

DIA has blocked a limited number of rooms at the following hotel:

Pullman Basel Europe
Clarastrasse 43
4058 Basel

Tel.: (+41)61/6908080
Fax: +44 20804348
Fax: (+41)61/6908880
Email: h5921@accor.com

at the rate of:
CHF 180 per room inclusive of breakfast, wifi and the mobility ticket for free use of public transport
To make your reservation please use this booking form.

Important: The room rate is available until 9 October 2014 or until the group block is sold-out, whichever comes first.

Contact Information 

Registration Questions
Phone.: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET

Agenda and Event Logistics
Magdalena Lewandowska, Event Manager
Phone: +41 61 225 51 65
Fax: +41 61 225 51 52

Program Committee 

Previous Next


Day 1 Thursday, Nov 6, 2014

  • 9:15AM - 10:00AM (Central European Standard Time)


    Session Chair(s):

    • Breffni Kennedy Martin
      Legal Representative, Data Controller, Consultant
      Regintel Ltd, Ireland

    This opening session will provide an insight into the regulatory challenges facing the life sciences industry from the emergence and introduction of new technologies such as cloud computing and mobile applications/devices and the impact upon data integrity. It will also look at how we may adopt a risk-based approach to ensuring continued GxP compliance of computerised systems in this new environment.


    • Reglatory Perspective
      Teri Stokes
      GXP International, United States
    • GAMP® 5 – Risk-based approach to GXP compliant computerised systems
      Sion Wyn
      Conformity Ltd, United Kingdom
  • 10:00AM - 10:30AM (Central European Standard Time)

    Panel Discussion, Questions & Answers
  • 10:30AM - 11:00AM (Central European Standard Time)

  • 11:00AM - 12:00PM (Central European Standard Time)


    Session Chair(s):

    • No-image Rolf Peter Banholzer, PhD
      Global Head GxP IT Systems & Processes
      Novartis Pharma AG, Switzerland

    Whilst 10 years ago, Computerized Systems Validation was a priority for many organisations, the today’s industry and regulators key focus is on data integrity. As a prerequisite for end to end clinical data integrity, computerized systems have to be validated and to be kept in a validated state. In particular in large Pharmaceutical Organizations and with full service providers, there is a level of Systems, Process, Organizational and Geographical Complexity that require another layer of governance and oversight than the typical controls described in numerous publications. Furthermore, additional data collection tools such as ePRO systems and eSource data concepts have to be properly integrated in clinical study setups.
    The objective of this session will be to consider how eClinical IT systems and platforms can enable end-to-end data integrity in today’s context of further going electronic and paperless, implementing global data management operations, insourcing of resources and outsourcing of services. In addition, Systems retirement and data storage and archiving will be addressed.


    • Ending the clinical IT lifecycle with decommissioning of GcP clinical data and System
      Jesper Ilm
      Senior Consultant
      epista IT , Denmark
    • Enabling Data Integrity with eClinical Systems when Collected by the Patient
      Valdo Arnera, MD
      General Manager Europe
      PHT Corporation, United States
    • Electronic Integrity at the Frontiers of eClinical Systems
      Teri Stokes
      GXP International, United States
  • 12:00PM - 12:30PM (Central European Standard Time)

    Panel Discussion, Questions & Answers
  • 12:30PM - 2:00PM (Central European Standard Time)

  • 2:00PM - 3:30PM (Central European Standard Time)


    Session Chair(s):

    • Thomas Haag
      Data Integrity Process Expert
      Novartis, Switzerland

    The session chair will provide a 20 min introduction to the multiple dimensions impacting data quality and data integrity including technology, systems, processes and organisational complexities, followed by an interactive workshop to further elaborate all dimensions based on real world examples provided by the workshop participants.


    • Data Integrity in Clinical Trials
      Thomas Haag
      Data Integrity Process Expert
      Novartis, Switzerland
  • 3:30PM - 4:00PM (Central European Standard Time)

  • 4:00PM - 5:00PM (Central European Standard Time)


    Session Chair(s):

    • Breffni Kennedy Martin
      Legal Representative, Data Controller, Consultant
      Regintel Ltd, Ireland

    The Session chairs of Session 3a and 3b will provide a brief summary of the discussions and conclusions to all meeting participants. There will be a further opportunity to discuss how business risk-based implementations of Computerized Systems effectively enable data integrity in complex business environments.

  • 5:00PM - 6:00PM (Central European Standard Time)


Day 2 Friday, Nov 7, 2014


The ISPE, DIA Workshop opens the possibility to a limited number of organisations to have tabletop exhibits at this event and take advantage of the participation of key stakeholders in the clinical research field to present and promote their activity and added value.

Exhibitors are granted a unique opportunity to meet attendees before and after sessions and during all breaks. As there are just a few stands, visibility can be guaranteed and tabletops will be strategically positioned to take advantage of meeting traffic, so the opportunities to speak with appropriate targets are ensured.

For more details, please contact Roxann Schumacher,

Exhibits Manager at roxann.schumacher@diaeurope.org or  +41 61 225 51 38



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