1. technology and computing

15th DIA Conference on European Electronic
Document Management
Standardisation – Blessing or Curse?
Event #14110
01-03 December 2014
Maritim Hotel Berlin, Germany
Programme Co-Chairs
Hans van Bruggen
Senior Regulatory Affairs Consultant,
eCTDconsultancy, the Netherlands
Karen Roy
Chief Business Development Officer, Phlexglobal
Ltd, UK
Programme Committee
Andrew P. Marr
Managing Director, Marr Consultancy Ltd, UK
Eldin Rammell
Managing Director, Rammell Consulting Ltd, UK
Overview
Standardisation is key to the success of adoption of new techniques and processes. If houses were not
wired with copper wires providing power of a standard voltage through a predefined power outlet,
Edison would not have been famous for his successful introduction of light bulbs. However, national or
regional standards have been developed for power outlets and voltage but nobody is trying to get the
responsible parties together to globally harmonise the voltage and power outlets. These kind of obvious
standards have become a commodity and when travelling abroad, everybody uses adaptors that make
the connection between regional power outlets and voltages.
How come that in the age of modern technology and quick communication we are still aiming at global
standards? Should we be less dogmatic about global standards? Should we focus more on adaptors? Or
electronic and automated adaptors that allow transfer of information from sender to recipient and vice
versa? This is not limited to industry-to-agency transfer, but is also applicable to transfers between CROs
and sponsor and between various applications within a company, such as, but not limited to, SAP, eDMS,
eTMF, eSubmission, RIM, LIMS, SPL, electronic health records, electronic data capture and electronic
forms.
Come and learn about the benefits and constraints associated with the various topic-related processes
and contribute to answering the question whether standardisation is a blessing or a curse.
Who Will Attend
Pre-Conference Tutorials
MONDAY, 1 DECEMBER 2014
09:00-17:00
Tutorial 1:
ELECTRONIC TRIAL MASTER FILES (ETMF) - MOVING
FROM IMPLEMENTATION TO PROJECT EXCELLENCE
Tutorial 2:
UNDERSTANDING THE IMPACT OF IDENTIFICATION OF
MEDICINAL PRODUCTS (IDMP) ON PROCESSES, DATA
PROVISION, GOVERNANCE AND IT ARCHITECTURE
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Academic researchers
Agency representatives (e.g. inspectors and reviewers)
Clinical operations representatives
CMC regulatory compliance specialists
CROs, CMOs and service providers
Document and records managers
IT and support personnel
Knowledge/IP professionals
Labelling specialists
Medical and technical writers
Pharmacovigilance professionals
Quality assurance and compliance professionals
Regulatory affairs/operations representatives
Standards implementation specialists and associates
Validation professionals
Objectives
Continuing Education
DIA meetings and training courses are generally
approved by the Commission for Professional
Development (CPD) of the Swiss Association of
Pharmaceutical Professionals (SwAPP) and the Swiss
Society of Pharmaceutical Medicine (SGPM) and
will be honoured with credits for pharmaceutical
medicine. All participants are eligible for these credits
and certificates are available.
• Understand the new requirements and the way they are being implemented by authorities and clinical
trial sponsors, including their operational impact
• Discuss and identify the key challenges and opportunities of the new provisions
• Recognise how companies and research institutions are fine-tuning and optimising processes to meet
the requirements for disclosure of trial data and for the management of clinical trials
• Exchange views between regulators, industry, patients, academia and other stakeholders
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WEDNESDAY | 3 DECEMBER 2014
08:00-08:30 | WELCOME COFFEE IN THE EXHIBITION AREA
08:30-10:00
TRACK 1 | SESSION 5
BRINGING THE REFERENCE MODELS TO LIFE!
Session Chairperson:
Steve Scribner, EDM Reference Model Core Committee member and Vice-chair of the TMF
Reference Model Steering Committee
The Document and Records Management (DRM) community of the DIA has been busy since
2009 in the formation and update of Reference Models (RM) for document and content
management. The currently published editions for both the eDM and the Trial Master File
(TMF) Reference Models are available on the DIA website – eDM Corner. To keep those models
updated to reflect the transformation of business processes, many updates and extensions
are being prepared to keep them relevant as well as to harmonise and include additional
process threads.
The current state of both models (eDM & TMF) will be discussed, how they are interrelated
and where they are being extended. This session will also include an overview of the model
evolution and other industry standards development. A short synopsis of the recently
released TMF Metrics Model and the annual TMF industry survey will be included.
Experts from the eDM RM Core Team and TMF RM Steering Committee will deliver hands-on
practical advice about model adoptions; including an interactive TMF RM best practice
discussion / Q&A session with attendees, which will drive TMF RM V3.0 activities.
08:30-10:00
TRACK 2 | SESSION 5
BUSINESS MODELS TO GET THE REGULATORY WORK DONE
Session Chairperson:
Andrew P. Marr, Managing Director, Marr Consultancy Ltd, UK
The nature of regulatory work is getting more complex as time goes on. Resources are
constrained and new models are being employed to get the work done in a more efficient
manner. This session will look at the challenges and opportunities being addressed currently
including outsourcing, dossier content management and how to address process, technology
and resource management.
Managing the Interfaces, Processes and Future Expectations in an Outsourcing
Relationship
Sophie Daniel, Senior Consultant, ProductLife Group, France
Harmonisation and Standardisation of Dossier Content, Information and Processes
Katy Page, Senior Director Submissions and Operations Support, Pfizer Ltd, UK
Monique Rivas, Co-founder and Chairman, LUZ, Inc., Switzerland
Synergies for Managing Regulatory eStrategy: Business process, technology, and
resourcing
Cynthia Piccirillo, Group Director, Global Dossier Management eStrategy, Bristol-Myers
Squibb, USA
Session Participants:
Karen Roy, Chair of the TMF Reference Model Steering Committee and Co-Chair TMF
Reference Model Committee
Lisa Mulcahy, Co-chair of the TMF Reference Model Committee and TMF Reference Model
Steering Committee member
Fran Ross, TMF Reference Model Steering Committee member
10:00-10:45 | COFFEE BREAK IN THE EXHIBITION AREA
10:45-12:15
TRACK 1 & 2 | SESSION 6
END-TO-END DIGITAL CONTENT AVAILABILITY
Session Chairperson:
Paul Fenton, President & CEO, Montrium, Canada
14:30-15:30
TRACKS 1 & 2 | SESSION 8
ACHIEVING COMPLIANCE WITH ELECTRONIC SYSTEMS- THE REGULATOR’S PERSPECTIVE
Session Chair:
Gunnar Danielsson, Senior Regulatory Advisor, Pharma Consulting Group, Former GCP
Inspector, MPA Sweden
The world of clinical R&D is evolving rapidly with new collaborative models emerging.
Regulatory expectations on eTMF availability are also becoming much clearer. The eTMF has
to evolve to be able to support the new requirements and this poses a particular challenge.
This session will focus on what the new requirements are and how we can ensure that we
have a comprehensive, timely and easily navigable eTMF which can easily be maintained and
accessed over time.
Enabling the New Drug Development Paradigm through Collaboration and Interchange
Paul Fenton, President & CEO, Montrium, Canada
How Readily Available is your eTMF?
Dorte Frejwald Christiansen, Advanced Business Consultant, Life Science Advisory, NNIT,
Denmark
Ownership and control of electronic clinical trial data and documents is clearly defined in
the regulations, whether it is the data (electronic data capture) or the documents (electronic
investigator site file). However with the move to cloud-based systems, more and more
sponsors are maintaining control of the systems, and therefore the access, meaning that the
Investigators can no longer show their ownership. This extends from eSource to live trial
systems to electronic archiving and is not in compliance to the Regulators requirements. In
this session, the views and perspectives of FDA and EMA (via the Danish Health and Medicines
Agency) will be provided.
Jonathan Helfgott, Associate Director for Risk Science (Acting), OSI, OC, CDER, FDA, USA
(remote participation)
Phillip Lange Møller, GCP Inspector, Danish Health and Medicines Authority, Denmark
Digital Preservation for Pharma: Comprehensive standard or flexible approach?
Pauline Sinclair, Digital Preservation Consultant, Preservica Ltd, UK
15:30 | END OF CONFERENCE
12:15-13:30 | LUNCH IN THE EXHIBITION AREA
13:30-14:30
TRACK 1 & 2 | SESSION 7
RISK-BASED APPROACHES TO ENSURE DATA INTEGRITY
Session Chairperson:
Peter Schiemann, Partner, Widler & Schiemann Ltd, Switzerland
In this session, participants will learn about the general concept of utilising information in the
clinical development environment and how this concept is being put into practice by different
organisations.
eDM as Foundation for Managing Clinical Trials
Peter Schiemann, Partner, Widler & Schiemann Ltd, Switzerland
ACRES
Greg Koski, Co-Founder, Alliance for Clinical Research (ACRES), USA
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are
their own opinion and not necessarily that of the organisation they represent, or that of
DIA. Speakers and agenda are subject to change without notice. Recording of any DIA
tutorial/workshop information in any type of media is prohibited without prior written
consent from DIA.