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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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Overview 

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
Switzerland

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
diaeurope@diaeurope.org

Agenda and Event Logistics
Magdalena Lewandowska, Event Manager
Phone: +41 61 225 51 65
Fax: +41 61 225 51 52
magdalena.lewandowska@diaeurope.org

Program Committee 

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Agenda  

Day 1 Thursday, Nov 06, 2014

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

    Session 1: DATA INTEGRITY AND A RISK-BASED APPROACH


    Session Chair(s):

    • Breffni Martin
      Legal Representative
      Regintel Ltd, Optum, Pharmacyclics, Canreg, 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.

    Speaker(s):

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

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

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

    Session 2: ENABLING DATA INTEGRITY WITH E-CLINICAL SYSTEMS


    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.

    Speaker(s):

    • 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
      Director
      GXP International, United States
  • 12:00PM - 12:30PM (Central European Standard Time)

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

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

    Session 3A: BREAK-OUT SESSION: RISK-BASED APPROACH


    Session Chair(s):

    • Volker Erat
      Quality Manager
      Novartis Pharama AG, Switzerland

    The session chair will provide a 20 min introduction to business riskbased approach to Computerized System Implementation followed by an interactive workshop discussing concrete, real world business process risk management assessments, including typical pitfalls and challenges that should be avoided or managed carefully.

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

    Session 3B: BREAK-OUT SESSION: DATA INTEGRITY


    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.

    Speaker(s):

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

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

    Session 4: FEEDBACK SESSION FROM BREAK-OUT SESSIONS


    Session Chair(s):

    • Breffni Martin
      Legal Representative
      Regintel Ltd, Optum, Pharmacyclics, Canreg, 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)

    NETWORKING DRINKS RECEPTION

Day 2 Friday, Nov 07, 2014

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

    Session 5: THE CHALLENGES OF CLOUD COMPUTING


    Session Chair(s):

    • Kathleen Gniecko
      IT Quality Management Services Head
      F.Hoffmann-La Roche, Switzerland

    These are challenging times for most pharmaceutical companies. The competiveness of the market place, loss of patents, increasing international regulatory requirements, and downward pressure on health care costs are just a few of the factors that are driving pharmaceutical companies to adopt strategies for cutting resources and costs. At the same time IT needs to support the challenges the businesses are facing and are being asked to deliver effective solutions while cutting costs without compromising quality, compliance, agility and flexibility. This has led to greater interest in Cloud Computing. The promises of cloud computing are certainly considerable: extremely fast and flexible solution delivery, on-demand scalability, high-demand business continuity services with easy solutions for backup and archiving. This session aims to look at the issues surrounding the adoption of such technologies and asks “Will cloud computing provide the capabilities and adoption levels while simultaneously meeting the regulatory compliance needs that are core to the Pharmaceutical sector?”

    Speaker(s):

    • Cloud Infrastructure as a Service (IaaS)
      Anders Vidstrup
      Senior IT Quality Subject Matter Expert
      NNIT, Denmark
    • Software as a Service (SaaS)
      Ekaterina Sidorova
      IGM Global Risk Manager for NIBR
      Novartis Pharma AG, Switzerland
    • Alternative Accreditation Models for Cloud Providers
      Magdalena Kurpierz
      CEO
      KVALITO AG, Switzerland
  • 10:00AM - 10:30AM (Central European Standard Time)

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

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

    Session 6: REGULATED MOBILE APPLICATIONS


    Session Chair(s):

    • Sion Wyn
      Owner
      Conformity Ltd, United Kingdom

    The accessibility of mobile platforms to the general public has become nearly universal in much of the world. In 2013 sales of smartphones exceed the sales of standard mobile phones, and this trend shows no sign of slowing. With this much computing power in everyone’s pocket it was inevitable that regulated companies would recognise an opportunity to use it for a variety of purposes. Some examples of leveraging mobile technology are of relatively low impact and will not interest regulators, some fall very clearly into the regulated arena, and finally some are not so clear. Even once the scope of regulatory relevance is settled, mobile devices present a significant challenge to control. The possibility of putting regulated applications, some of which may be classified as medical devices, into the pockets of the public is new ground for the industry. Never before has regulated software run on platforms where the process owner has little or no control over the platform. This session is intended to consider a risk-based approach to implementing and supporting mobile devices in a regulated environment.

    Speaker(s):

    • Using a Mobile App for Review and Approval in a Validated Document Management System
      Markus Kast
      Solution Architect
      F. Hoffmann La-Roche Ltd, Switzerland
    • Delivering GxP Compliant mHealth and Mobile Applications – A practical case study
      Mark Stevens
      Operations Director and Principal Consultant
      Formpipe. GxP, United Kingdom
    • Regulated Mobile Applications
      Sion Wyn
      Owner
      Conformity Ltd, United Kingdom
  • 12:00PM - 12:30PM (Central European Standard Time)

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

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

    BREAK-OUT SESSION: CLOUD COMPUTING


    Session Chair(s):

    • Kathleen Gniecko
      IT Quality Management Services Head
      F.Hoffmann-La Roche, Switzerland

    This session will provide an opportunity for particpants to be involved in an interactive workshop based on cloud computing.

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

    BREAK-OUT SESSION: REGULATED MOBILE APPS


    Session Chair(s):

    • Sion Wyn
      Owner
      Conformity Ltd, United Kingdom

    This session will provide an opportunity for participants to be involved in an interactive workshop based on mobile applications.

  • 3:30PM - 4:00PM (Central European Standard Time)

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

    Session 8: FEEDBACK SESSION FROM BREAK-OUT SESSIONS


    Session Chair(s):

    • Kathleen Gniecko
      IT Quality Management Services Head
      F.Hoffmann-La Roche, Switzerland
    • Sion Wyn
      Owner
      Conformity Ltd, United Kingdom

    This session will allow the participants of the two break-out sessions on Cloud Computing and Mobile Applications to feed back and share their experience with the full conference group.

  • 5:00PM - 5:30PM (Central European Standard Time)

    SUMMARY OF TWO WORKSHOP DAYS, OUTCOME, FUTURE, WRAP UP

Exhibits  

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

 

 

Registration Fees 

Other Fees

Student
€200.00
Standard
€1300.00

Member

Member Academia
€725.00
Member Government
€725.00
Member Standard
€1450.00
One Day Rate
€435.00
One Day Rate
€870.00
One Day Rate
€435.00

Non-Member

NonMember Academia
€855.00
NonMember Government
€855.00
NonMember Standard
€1600.00
One Day Rate
€513.00
One Day Rate
€513.00
One Day Rate
€960.00
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