15th dia conference on european electronic 15th dia conference on european electronic document...

15th DIA Conference on European Electronic Document ManagementStandardisation – Blessing or Curse?

Programme Co-Chairs

Hans van BruggenSenior Regulatory Affairs Consultant, eCTDconsultancy, the Netherlands

Karen RoyChief Business Development Officer, Phlexglobal Ltd, UK

Programme Committee

Andrew P. MarrManaging Director, Marr Consultancy Ltd, UK

Eldin RammellManaging 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• 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• 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

Event #141101-3 December 2014Maritim Hotel Berlin, Germany

Continuing EducationDIA 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. This conference has been accredited with 12 credits. All participants are eligible for these credits.

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

FINAL PROGRAMME

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PRE-CONFERENCE FULL DAY TUTORIALS ON MONDAY, 1 DECEMBER 2014

START OF CONFERENCE TUESDAY | 2 DECEMBER 2014

08:30-10:00 TRACKS 1 & 2 | SESSION 1 RIGA 16 + 17

WELCOME AND INTRODUCTION: STANDARDISATON, WHERE ARE WE?Session Chair:Eldin Rammell, Managing Director, Rammell Consulting Ltd, UK

Standardisation is becoming one of the most critical topics as our industry seeks to reduce costs, encourage harmonisation and improve efficiency. Our keynote speakers will bring us up-to-date with some key developments in this space for electronic document management and challenge our thinking right at the outset of our conference. Our speakers will cover standardisation developments for trial master files, regulatory submissions, IDMP and telematics, to name but a few!

Document Management Technologies - what does the future hold?Jonathan Burd, Solutions Director, GxPi, UK

EU Telematics StrategyThomas Balzer, Project Manager, BfArM, Germany

ISO, the IDMP Standards and Their Impact in the CommunityChristian Hay, Senior Consultant Healthcare, GS1 Global Office, Belgium

10:00-10:30 | COFFEE BREAK IN THE EXHIBITION AREA


HOW BUSINESS CONTRIBUTES TO PROCESS VALIDATION/INTEGRATIONSession Chair:Hans van Bruggen, Senior Regulatory Affairs Consultant, eCTDconsultancy, the Nether-lands

Over the past 30 years we have shifted from information management on paper to digital information management using computers. However, until now, many processes are still based on paper thinking. Often we do not fully trust the automated processes, even though the systems have proven to do jobs as intended. People still tend to exchange information through e-mail, work outside validated systems and try to apply shortcuts in electronic processes. This session will explain more about why systems should be perceived as reliable, how data can be considered authentic and how to achieve that true perception by the users.

How Many Eggs Make Six?Russell Joyce, Director & Principal Consultant, Heath Barrowcliffe Consulting, UK

Comprehensive Regulatory View for Life Sciences Steve Scribner, Principal Consultant- Life Sciences, EMC, USA

Implementing an eDMS and eSubmission Tool in Two MonthsKarmen Umek Luzar, Consultant & Project Manager, INFOTEHNA, Slovenia

12:00 - 13:30 | LUNCH IN THE EXHIBITION AREA

Tutorial 1 | 09:00-17:00 SALON 4

ELECTRONIC TRIAL MASTER FILES (ETMF) - MOVING FROM IMPLEMENTATION TO PROJECT EXCELLENCECo-Instructors:Eldin Rammell, Managing Director, Rammell Consulting, UKKaren Roy, Chief Business Development Officer, Phlexglobal Ltd, UK

Technology solutions for managing electronic Trial Master File (eTMF) documents are now established in many sponsors and contract research organisations. However, companies often experience challenges as they begin to implement solutions, sometimes several years later! This tutorial will provide attendees with an opportunity to discuss some of the more challenging aspects of eTMF implementation. Through instructor-facilitated discussions, guidance will be provided in a wide range of relevant topics.

Learning ObjectivesAt the conclusion of this tutorial, attendees will be able to:

• Avoid common eTMF implementation issues• Apply appropriate change management strategies for their organisation• Evaluate the health of their TMF using industry standard metrics• Adapt their eTMF strategy for interoperability

Target AudienceProfessionals involved in the following areas:

• Clinical Records Managers/Archivists• eTMF Project Managers (IT & Business)• TMF Stakeholders

Tutorial 2 | 09:00-17:00 SALON 5

UNDERSTANDING THE IMPACT OF IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP) ON PROCESSES, DATA PROVISION, GOVERNANCE AND IT ARCHITECTURE Co-Instructors:Frits Stulp, Managing Director, Mesa Arch Consulting, the NetherlandsJasper Riksen, IDMP Business Architecture Associate, Astellas Pharma Europe B.V., the Netherlands

The tutorial will give insight in the following areas:

• Background of the IDMP standards and legislation• Structure and contents of the IDMP standards• Typical data mapping activities and results• IT architecture and application consequences• Specific areas of attention (i.e.; clinical particulars and reporting of consistency of product

information)• Questions and answers

Learning ObjectivesAt the conclusion of this tutorial, attendees will be able to: • Understand the structure of the International Organisation for Standards (ISO) IDMP

standards and data requirements• Recognise the impact on existing processes and IT architecture/applications• Identify the steps of analysis required to determine company specific impact

Target AudienceProfessionals involved in regulatory data submission, like XEVMPD and upcoming IDMP, and the preparation thereof:• Regulatory Operations Managers• Regulatory Affairs Managers• Business Information Managers (as intermediary between regulatory and IT departments)• Life Sciences Consultants• Software Developers in the regulatory environment

10:30 - 11:00 | COFFEE BREAK

12:30 - 14:00 | LUNCH BREAK

15:30 - 16:00 | COFFEE BREAK

07:30-08:30 | REGISTRATION AND WELCOME COFFEE

08:30 | ARRIVAL & REGISTRATION

FEEDBACK

We value your feedback on the content and organisation of the conference. The electronic

survey will also be sent to you on the last day of the conference and can also be accessed

through the following link:

https://www.surveymonkey.com/s/Y72636V

CERTIFICATE OF ATTENDANCE

A Certificate of Attendance will be sent to all attendees electronically within a week’s time

after the event. Please note certification requires full attendance to the event.

For more information please contact DIA EMEA Contact Center on

[email protected] or call +41 61 225 5151.

PRESENTATION ACCESS INFORMATION

As a benefit of registration, presentations are available on the DIA website before the event

start date. Updated versions will be available from Tuesday, 09 December 2014.

Please log in to MyDIA and choose “My Presentation Downloads”, where you will be able to

download all presentations that have been submitted by speakers.

Note: You will need to enter your DIA User ID and password to verify your status. If you have

forgotten your DIA User ID and password, use the Login Reminder.

After logging in to My DIA, you will see presentation PDFs from all the DIA offerings you

have attended in the past 6 months. Simply choose the presentation you would like to view

or download.

Please note that if a presentation is not available on the website, it is because:

• The presenter has not (yet) supplied us with a presentation file

• There was no slide presentation planned by the speaker

• The speaker did not agree to share it with other participants

• You have not yet paid the registration fee

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13:30-15:00 TRACK 1 SESSION 3 RIGA 16

PHARMACOVIGILANCE LIFECYCLE MANAGEMENT FROM CLINICAL TESTING TO POST-MARKETING SURVEILLANCE – ELEMENTS, PERMANENT AND AD HOC REQUIREMENTS, AND THE POSSIBILITY TO MANAGE THEM ELECTRONICALLY Session Chair: Markus Dehnhardt, Pharmacovigilance Manager, QPPV, Kohne Pharma, Germany

The session will focus on a review of the electronic document management for regulated documents of the Trial Master File (TMF), the Pharmacovigilance System Masterfile (PSMF), and during Pharmacovigilance lifecycle management. We will identify the individual documents required, their structure and content, and try to highlight the possibilities for automated information management.

Moving from an On-Premise to a Cloud-Based eDMS for Regulated Documents and eTMF- Part 1Matthias Ganz, Vice President R&D IT, Ipsen, France

Moving from an On-Premise to a Cloud-Based eDMS for Regulated Documents and eTMF- Part 2Benoit Poupin, Director IT Regulatory Affairs and CMO, Ipsen, France

Managing the Intersections between Regulatory and Pharmacovigilance Mohamed Adib Senior Director, Global Regulatory Affairs, Head of GRA Grünenthal Brands, Grünenthal, Germany


eREGULATORY CHALLENGESSession Chair:Jörg Schnitzler, Head of Global Regulatory Affairs Operations, Boehringer Ingelheim Pharma, Germany

Several new standards for the transmission of structured regulatory information are being implemented over the course of the next two to four years. While the deadline for EVMPD is approaching fast, the preparation for IDMP is starting in parallel. And ten years after the introduction of the eCTD standard the development of the Next Major Version v4.0 is reaching ICH Step 2 and opens now for public consultation. All these new requirements will require flexible and scalable technical solutions to handle the transition from existing standards.

Learnings from XEVMPD to Take Forward in IDMPJasper Riksen, IDMP Business Architecture Associate, Astellas Pharma Europe B.V., the Netherlands

Cloud-Based Management of eCTD Global Submission PlannersMaureicha Marcussen, Chief Executive Officer, Auditgraph, USA

RPS and eCTD v.4.0Jörg Schnitzler, Head of Global Regulatory Affairs Operations, Boehringer Ingelheim Pharma, Germany



eTMF CHALLENGESSession Chair: Karen Roy, Chief Business Development Officer, Phlexglobal Ltd, UK

An electronic Trial Master File (eTMF) is not just a piece of technology, it is all about getting efficient and effective processes and workflows in place to ensure that the eTMF is contemporaneous and ready for inspection at any time. This session will take you through implementation, through dealing with CROs and ending up focussing on inspections.

eTMF Standardisation from a CRO PerspectiveJamie Toth, Director, Business Process & Solutions - eTMF, Clinical Development Services, Covance, USA

“The Road to Hell is Paved with Good Intentions” and eTMF Implementations…Anything in Common?Lisa Mulcahy Owner and Principal Consultant, Mulcahy Consulting LLC, USA

How to Prepare for an eTMF Inspection Wendy Trimboli, Associate Director, TMF Process Management and Quality Control, Global Regulatory, Operations, GRA, Eisai Product Creation Systems (EPCS), USA


PREPARING FOR THE IMPLEMENTATION OF ISO IDMPSession Chair: Andrew P. Marr, Managing Director, Marr Consultancy Ltd, UK

The legislative deadline of July 2016 for implementation of the International Organisation for Standards (ISO) standards for Identification of Medicinal Products (IDMP) is rapidly approaching. The session will cover the current status and agency plans and expectations, the general position of industry regarding the ability and readiness to implement and an assessment from one company of their approach to assessment of the impact and preparing for implementation.

EU Agencies’ Plans and Preparation for the Implementation of IDMPThomas Balzer, Project Manager, BfArM, Germany

IDMP: The challenges for industry to address implementation in the EU Remco Munnik, Regulatory Information Director, Asphalion, Spain

Planning for IDMP: One company’s approach to preparation Rolf Brockmeyer, Director of Global Compliance Management, Bayer, Germany

17:00 | DRINKS RECEPTION IN THE EXHIBITION AREA

18:00 | END OF DAY ONE

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08:30-10:00 TRACK 1 | SESSION 5 RIGA 16

BRINGING THE REFERENCE MODELS TO LIFE!Session Chair: 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.

Session Participants:Karen Roy, Chair of the TMF Reference Model Steering Committee and Co-Chair TMF Reference Model CommitteeLisa Mulcahy, Co-chair of the TMF Reference Model Committee and TMF Reference Model Steering Committee memberFran Ross, TMF Reference Model Steering Committee member

08:30-10:00 TRACK 2 | SESSION 5 RIGA 17

BUSINESS MODELS TO GET THE REGULATORY WORK DONESession Chair: 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 ProcessesKaty Page, Senior Director Submissions and Operations Support, Pfizer Ltd, UKMonique 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

08:00-08:30 | WELCOME COFFEE IN THE EXHIBITION AREA

WEDNESDAY | 3 DECEMBER 2014

10:45-12:15 TRACK 1 & 2 | SESSION 6 RIGA 16 + 17

END-TO-END DIGITAL CONTENT AVAILABILITYSession Chair: Paul Fenton, President & CEO, Montrium, Canada

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 InterchangePaul Fenton, President & CEO, Montrium, Canada

How Readily Available is your eTMF?Dorte Frejwald Christiansen, Advanced Business Consultant, Life Science Advisory, NNIT, Denmark

Digital Preservation for Pharma: Comprehensive standard or flexible approach?Pauline Sinclair, Digital Preservation Consultant, Preservica Ltd, UK

12:15-13:30 | LUNCH IN THE EXHIBITION AREA

13:30-14:30 TRACK 1 & 2 | SESSION 7 RIGA 16 + 17

RISK-BASED APPROACHES TO ENSURE DATA INTEGRITYSession Chair: 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 TrialsPeter Schiemann, Partner, Widler & Schiemann Ltd, Switzerland

ACRESGreg Koski, Co-Founder, Alliance for Clinical Research (ACRES), USA


ACHIEVING COMPLIANCE WITH ELECTRONIC SYSTEMS- THE REGULATOR’S PERSPECTIVESession Chair: Gunnar Danielsson, Senior Regulatory Advisor, Pharma Consulting Group, Former GCP Inspector, MPA Sweden

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

15:30 | END OF CONFERENCE


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.

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List of Exhibiting Companies and Floor Plan

Company Country Booth Number

arivis AG Germany 2

BIOVIA Ireland 13

Cunesoft GmbH Germany 15

EMC France 14

Ennov France 3

EXTEDO Germany 7

fme Germany 5

Formpipe United Kingdom 4

Company Country Booth Number

INFOTEHNA Group LLC Slovenia 8

LORENZ Life Science Group Germany 6

Montrium Canada 9

PAREXEL United States 12

Phlexglobal Ltd United Kingdom 10

Pilgrim Quality Solutions United States 11

ProductLife Group France 1

Galerie

elevatorselevators

Konferenzraum 11

Saal Maritim Empore

1 2 3 4 5 6

7 8 9

10

CATERING CATERING CATERING

CATE

RIN

GCATE

RIN

GCATE

RIN

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11

12

13

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TO/FROM SESSION ROOMS

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Last First Company Country

Adib Mohamed Gruenethal GmbH Germany

Alberici Marco Chiesi Farmaceutici Spa Italy

Appel Julie Novo Nordisk A/S Denmark

Arduini Stefania Chiesi Farmaceutici Italy

Baldursdóttir Katrín Actavis Group hf. Iceland

Ballo Chaba Veeva Systems France

Balzer Thomas BfArM Germany

Bauer Petra BIOVIA Ireland

Baumgaertner Christa Boehringer Ingelheim Pharma GmbH & Co. KG Germany

Bergsteiner Tore MAIN5 GmbH Germany

Bernadelli Roberta Chiesi Pharma Italy

Boegelund Jensen Mette Leo Pharma A/S Denmark

Braga Frederico HighPoint Solutions Switzerland

Braun Romuald INFOTEHNA Group LLC Slovenia

Brezneva Alina ASTELLAS the Netherlands

Brockmeyer Rolf Bayer Pharma AG Germany

Bujna Csaba BIOVIA Ireland

Bunse Peter fme AG Germany

Burd Jonathan GXPi United Kingdom

Cahen Jean-Michel Novartis Pharma AG Switzerland

Christiansen Dorte Frejwald NNIT Denmark

Daniel Sophie ProductLife Group France

Danielsson Gunnar Pharma Consulting Group Sweden

Darasse Quentin F.Hoffmann- La Roche Ltd Switzerland

Dattner Offer arivis AG Germany

Davias Isabelle Sanofi France

Dehnhardt Markus Kohne Pharma GmbH Germany

Dunker Thorsten BioMedion GmbH Germany

Eisner Max EXTEDO GmbH Germany

Eslau Anna Pharmaceutical Econsulting A/S Denmark

Evans Schuler Sharon DIA Europe, Middle East & Africa Switzerland

Farag Sahar Ministry of Health Egypt

Fenton Paul Montrium Canada

Frejwald Christiansen Dorte NNIT Denmark

Fritel Alexis EMC Information Technology Group France

Gaertner Ulrike elderbrook solution GmbH Germany

Ganz Mathias Ipsen France

Gaussens Erick ProductLife Group France

Gebhardt Jenny Q-FINITY Germany

Ghazi Abdul KVALITO Deutschland GmbH Germany

Gjoka Glenda MHRA United Kingdom

Glemser Ray Glemser United States

Gonnaud Etienne NextDocs Corporation United Kingdom

Goundalkar Lakshmeenarayana ArisGlobal United States

Guenther Torsten fme AG Germany

Haarmeier Marc euroscript Systems GmbH Germany

Haine Richard EMC Information Technology Group United Kingdom

Hameed Shakul Baxter Innovations GmbH Austria

Hay Christian GS1 Global Office Belgium

Heater Greg i4i Canada

Helfgott Jonathan FDA United States

Hofmeister Robert ProductLife Group France

List of Participants

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Holland Chris GSK United Kingdom

Ito Tatsuya Research and Enterprise Development, University of Bristol United Kingdom

Joyce Russell Heath Barrowcliff Consulting Ltd United Kingdom

Kaufmann Sofia euroscript Deutschland GmbH Germany

Knez Christoph Pilgrim Quality Solutions United States

Koppers Daniel Cunesoft GmbH Germany

Koski Greg Alliance For Clinical Research Excellence and Safety (ACRES) United States

Laumeier Clemens EXTEDO GmbH Germany

Lauridsen Michael Sigma Sweden

Le Corre Alain EMC Information Technology Group France

Lehnert Beatrix Hexal AG Germany

Lenitzki Tina fme AG Germany

Leslie Vinita Biogen-Idec United States

Loepp Georg Informatica GmbH Germany

Lutomska Anna arivis AG Germany

Lyngvig Jytte DIA Europe, Middle East & Africa Switzerland

Malhotra Rohit Accenture United Kingdom

Marchand Julien Ferring International Center S.A. Switzerland

Marcussen Mauricha Auditgraph United States

Marr Andrew Marr Consultancy Ltd United Kingdom

Marsac Yoann ENNOV France

May Jennie Allergan United Kingdom

McDonnell Monica Informatica Switzerland

McLaurin Eleanor PAREXEL United States

Mechler Simone Actelion Pharmaceuticals Ltd Switzerland

Meckel Hubert EMC Information Technology Group Germany

Mensa Xavier Veeva Systems Europe Germany

Metz Susan PAREXEL United States

Meyer Auf Der Heide Ulrike Novartis Pharma AG Switzerland

Middag Patrick Bristol-Myers Squibb Belgium

Moller Philip Lange Danish Health and Medicines Authority Denmark

Mueller-Andriamboavonjy Nathalie ARIAD Pharmaceuticals (Europe) Sarl Switzerland

Mulcahy Lisa Mulcahy Consulting, LLC United States

Munnik Remco Asphalion S.L. Spain

Munte Max EXTEDO, Inc. United States

Näff Stefan Deloitte Consulting LLP Switzerland

Neurauter Gerhard EXTEDO GmbH Germany

Nielsen Claus Novo Nordisk A/S Denmark

Page Katy Pfizer Ltd United Kingdom

Paradis Valérie Montrium Inc. Canada

Paris Oliver ENNOV France

Pauli Timm PharmaLex GmbH Germany

Perez Castillo Ferréol ENNOV France

Piccirillo Cynthia Bristol-Myers Squibb United States

Pidun Anita Bayer Pharma AG Germany

Poupin Benoit Ipsen France

Quist Pernelle Pharmaceutical Econsulting A/S Denmark

Rammell Eldin Rammell Consulting Ltd United Kingdom

Reynolds Peter Adlib Software United Kingdom

Riksen Jasper Astellas Pharma Europe BV the Netherlands

Rivas Monique LUZ Inc Switzerland

Ross Fran Paragon Solutions United States

Roy Karen Phlexglobal Ltd United Kingdom

Rydin Jonas Formpipe Software AB Sweden

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Savu Nora F.Hoffmann-La Roche Ltd Switzerland

Schamberger Manuela EMC Information Technology Group Germany

Schappeit Christian Boehringer Ingelheim Pharma GmbH & Co. KG Germany

Schaub Michael ASPHALION S.L. Munich Office Germany

Schiemann Peter Widler & Schiemann Ltd Switzerland

Schlaps Dieter It-Consulting Life Science Germany

Schmitt Sebastien ProductLife AG Switzerland

Schnettelker Florian KVALITO Deutschland GmbH Germany

Schnitzler Joerg Boehringer Ingelheim Pharma GmbH & Co KG Germany

Schultz Michele Xendo Deutchland GmbH Germany

Schumacher Roxann DIA Europe, Middle East & Africa Switzerland

Schwarz Rainer Cunesoft GmbH Germany

Schweigart Alexander EMC Information Technology Group Germany

Scribner Steve EMC Information Technology Group United States

Sedoun Irina Biopartners Switzerland

Sinclair Pauline Preservica Ltd United Kingdom

Stanic Damir INFOTEHNA Group Slovenia

Stueben Joerg Boehringer Ingelheim Pharma GmbH Germany

Stulp Frits Mesa Arch Consulting the Netherlands

Suchanek Andreas arivis AG Germany

Theron Guillaume EMC Information Technology Group France

Toth Jamie Covance Inc. United States

Trimboli Wendy Eisai Inc. United States

Tschorn Ursula Dacon Datenbank Consulting GmbH Germany

Twitchen Jane Biogen Idec United Kingdom

Umek Luzar Karmen INFOTEHNA Slovenia

van Bruggen Hans eCTDconsultancy and Qdossier the Netherlands

Vanevski Igor Medicines and Medical Devices Agency of Serbia Serbia

Varney Anne-Mette Novo Nordisk A/S Denmark

Vellani Simona EMC Information Technology Group France

Wastl Andreas EXTEDO Germany

Williams Kornelia Allergan United Kingdom

Yousry Asamaa Astra Travel Egypt