15th DIA Conference on European Electronic 15th DIA Conference on European Electronic Document...
Transcript of 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
10:30-12:00 TRACKS 1 & 2 | SESSION 2 RIGA 16 + 17
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
13:30-15:00 TRACK 2 SESSION 3 RIGA 17
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
15:00-15:30 | COFFEE BREAK IN THE EXHIBITION AREA
15:30-17:00 TRACK 1 SESSION 4 RIGA 16
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
15:30-17:00 TRACK 2 SESSION 4 RIGA 17
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
14:30-15:30 TRACKS 1 & 2 | SESSION 8 RIGA 16 + 17
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
10:00-10:45 | COFFEE BREAK IN THE EXHIBITION AREA
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
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Konferenzraum 11
Saal Maritim Empore
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7 8 9
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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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Last First Company Country
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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Last First Company Country
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