FINAL PROGRAMME. 15th DIA Conference on European Electronic Document Management Standardisation Blessing or Curse? Overview. Programme Co-Chairs

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1 15th DIA Conference on European Electronic Document Management Standardisation Blessing or Curse? Event # December 2014 Maritim Hotel Berlin, 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 Pre-Conference Tutorials MONDAY, 1 DECEMBER :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 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 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. This conference has been accredited with 12 credits. All participants are eligible for these credits. FINAL PROGRAMME

2 2 PRE-CONFERENCE FULL DAY TUTORIALS ON MONDAY, 1 DECEMBER :30 ARRIVAL & REGISTRATION Tutorial 1 09:00-17:00 SALON 4 ELECTRONIC TRIAL MASTER FILES (ETMF) - MOVING FROM IMPLEMENTATION TO PROJECT EXCELLENCE Co-Instructors: Eldin Rammell, Managing Director, Rammell Consulting, UK Karen 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 Objectives At 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 Audience Professionals 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 Netherlands Jasper 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 Objectives At 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 Audience Professionals 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 START OF CONFERENCE TUESDAY 2 DECEMBER :30-08:30 REGISTRATION AND WELCOME COFFEE 08:30-10:00 TRACKS 1 & 2 SESSION 1 RIGA WELCOME AND INTRODUCTION: STANDARDISATON, WHERE ARE WE? 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 Strategy Thomas Balzer, Project Manager, BfArM, ISO, the IDMP Standards and Their Impact in the Community Christian Hay, Senior Consultant Healthcare, GS1 Global Office, Belgium 10:30-12:00 TRACKS 1 & 2 SESSION 2 RIGA HOW BUSINESS CONTRIBUTES TO PROCESS VALIDATION/INTEGRATION Hans van Bruggen, Senior Regulatory Affairs Consultant, ectdconsultancy, the Netherlands 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 , 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 Months Karmen Umek Luzar, Consultant & Project Manager, INFOTEHNA, Slovenia 10:00-10:30 COFFEE BREAK IN THE EXHIBITION AREA 12:00-13:30 LUNCH IN THE EXHIBITION AREA

3 3 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 Markus Dehnhardt, Pharmacovigilance Manager, QPPV, Kohne Pharma, 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 1 Matthias Ganz, Vice President R&D IT, Ipsen, France Moving from an On-Premise to a Cloud-Based edms for Regulated Documents and etmf- Part 2 Benoit 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, 13:30-15:00 TRACK 2 SESSION 3 RIGA 17 eregulatory CHALLENGES Jörg Schnitzler, Head of Global Regulatory Affairs Operations, Boehringer Ingelheim Pharma, 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 IDMP Jasper Riksen, IDMP Business Architecture Associate, Astellas Pharma Europe B.V., the Netherlands Cloud-Based Management of ectd Global Submission Planners Maureicha Marcussen, Chief Executive Officer, Auditgraph, USA RPS and ectd v.4.0 Jörg Schnitzler, Head of Global Regulatory Affairs Operations, Boehringer Ingelheim Pharma, 15:00-15:30 COFFEE BREAK IN THE EXHIBITION AREA 15:30-17:00 TRACK 1 SESSION 4 RIGA 16 etmf CHALLENGES 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 Perspective Jamie 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 IDMP 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 IDMP Thomas Balzer, Project Manager, BfArM, 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, 17:00 DRINKS RECEPTION IN THE EXHIBITION AREA 18:00 END OF DAY ONE 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: 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 diaeurope@diaeurope.org or call 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 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

4 4 WEDNESDAY 3 DECEMBER :00-08:30 WELCOME COFFEE IN THE EXHIBITION AREA 08:30-10:00 TRACK 1 SESSION 5 RIGA 16 BRINGING THE REFERENCE MODELS TO LIFE! 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 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 08:30-10:00 TRACK 2 SESSION 5 RIGA 17 BUSINESS MODELS TO GET THE REGULATORY WORK DONE 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., Synergies for Managing Regulatory estrategy: Business process, technology, and resourcing Cynthia Piccirillo, Group Director, Global Dossier Management estrategy, Bristol-Myers Squibb, USA 10:00-10:45 COFFEE BREAK IN THE EXHIBITION AREA 10:45-12:15 TRACK 1 & 2 SESSION 6 RIGA END-TO-END DIGITAL CONTENT AVAILABILITY 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 Interchange Paul 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 RISK-BASED APPROACHES TO ENSURE DATA INTEGRITY Peter Schiemann, Partner, Widler & Schiemann Ltd, 14:30-15:30 TRACKS 1 & 2 SESSION 8 RIGA ACHIEVING COMPLIANCE WITH ELECTRONIC SYSTEMS- THE REGULATOR S PERSPECTIVE 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. 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, ACRES Greg Koski, Co-Founder, Alliance for Clinical Research (ACRES), USA

5 5 List of Exhibiting Companies and Floor Plan Company Country Booth Number arivis AG 2 BIOVIA Ireland 13 Cunesoft GmbH 15 EMC France 14 Ennov France 3 EXTEDO 7 fme 5 Formpipe United Kingdom 4 Company Country Booth Number INFOTEHNA Group LLC Slovenia 8 LORENZ Life Science Group 6 Montrium Canada 9 PAREXEL United States 12 Phlexglobal Ltd United Kingdom 10 Pilgrim Quality Solutions United States 11 ProductLife Group France 1 TO/FROM SESSION ROOMS CATERING CATERING CATERING elevators elevators CATERING 10 Saal Maritim Empore 16 CATERING CATERING

6 6 List of Participants Last First Company Country Adib Mohamed Gruenethal GmbH 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 Bauer Petra BIOVIA Ireland Baumgaertner Christa Boehringer Ingelheim Pharma GmbH & Co. KG Bergsteiner Tore MAIN5 GmbH Bernadelli Roberta Chiesi Pharma Italy Boegelund Jensen Mette Leo Pharma A/S Denmark Braga Frederico HighPoint Solutions Braun Romuald INFOTEHNA Group LLC Slovenia Brezneva Alina ASTELLAS the Netherlands Brockmeyer Rolf Bayer Pharma AG Bujna Csaba BIOVIA Ireland Bunse Peter fme AG Burd Jonathan GXPi United Kingdom Cahen Jean-Michel Novartis Pharma AG Christiansen Dorte Frejwald NNIT Denmark Daniel Sophie ProductLife Group France Danielsson Gunnar Pharma Consulting Group Sweden Darasse Quentin F.Hoffmann- La Roche Ltd Dattner Offer arivis AG Davias Isabelle Sanofi France Dehnhardt Markus Kohne Pharma GmbH Dunker Thorsten BioMedion GmbH Eisner Max EXTEDO GmbH Eslau Anna Pharmaceutical Econsulting A/S Denmark Evans Schuler Sharon DIA Europe, Middle East & Africa Farag Sahar Ministry of Health Egypt Fenton Paul Montrium Canada Frejwald Christiansen Dorte NNIT Denmark Fritel Alexis France Gaertner Ulrike elderbrook solution GmbH Ganz Mathias Ipsen France Gaussens Erick ProductLife Group France Gebhardt Jenny Q-FINITY Ghazi Abdul KVALITO Deutschland GmbH 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 Haarmeier Marc euroscript Systems GmbH Haine Richard 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

7 7 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 Knez Christoph Pilgrim Quality Solutions United States Koppers Daniel Cunesoft GmbH Koski Greg Alliance For Clinical Research Excellence and Safety (ACRES) United States Laumeier Clemens EXTEDO GmbH Lauridsen Michael Sigma Sweden Le Corre Alain France Lehnert Beatrix Hexal AG Lenitzki Tina fme AG Leslie Vinita Biogen-Idec United States Loepp Georg Informatica GmbH Lutomska Anna arivis AG Lyngvig Jytte DIA Europe, Middle East & Africa Malhotra Rohit Accenture United Kingdom Marchand Julien Ferring International Center S.A. Marcussen Mauricha Auditgraph United States Marr Andrew Marr Consultancy Ltd United Kingdom Marsac Yoann ENNOV France May Jennie Allergan United Kingdom McDonnell Monica Informatica McLaurin Eleanor PAREXEL United States Mechler Simone Actelion Pharmaceuticals Ltd Meckel Hubert Mensa Xavier Veeva Systems Europe Metz Susan PAREXEL United States Meyer Auf Der Heide Ulrike Novartis Pharma AG Middag Patrick Bristol-Myers Squibb Belgium Moller Philip Lange Danish Health and Medicines Authority Denmark Mueller-Andriamboavonjy Nathalie ARIAD Pharmaceuticals (Europe) Sarl Mulcahy Lisa Mulcahy Consulting, LLC United States Munnik Remco Asphalion S.L. Spain Munte Max EXTEDO, Inc. United States Näff Stefan Deloitte Consulting LLP Neurauter Gerhard EXTEDO GmbH 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 Perez Castillo Ferréol ENNOV France Piccirillo Cynthia Bristol-Myers Squibb United States Pidun Anita Bayer Pharma AG 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 Ross Fran Paragon Solutions United States Roy Karen Phlexglobal Ltd United Kingdom Rydin Jonas Formpipe Software AB Sweden

8 8 Last First Company Country Savu Nora F.Hoffmann-La Roche Ltd Schamberger Manuela Schappeit Christian Boehringer Ingelheim Pharma GmbH & Co. KG Schaub Michael ASPHALION S.L. Munich Office Schiemann Peter Widler & Schiemann Ltd Schlaps Dieter It-Consulting Life Science Schmitt Sebastien ProductLife AG Schnettelker Florian KVALITO Deutschland GmbH Schnitzler Joerg Boehringer Ingelheim Pharma GmbH & Co KG Schultz Michele Xendo Deutchland GmbH Schumacher Roxann DIA Europe, Middle East & Africa Schwarz Rainer Cunesoft GmbH Schweigart Alexander Scribner Steve United States Sedoun Irina Biopartners Sinclair Pauline Preservica Ltd United Kingdom Stanic Damir INFOTEHNA Group Slovenia Stueben Joerg Boehringer Ingelheim Pharma GmbH Stulp Frits Mesa Arch Consulting the Netherlands Suchanek Andreas arivis AG Theron Guillaume France Toth Jamie Covance Inc. United States Trimboli Wendy Eisai Inc. United States Tschorn Ursula Dacon Datenbank Consulting GmbH 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 France Wastl Andreas EXTEDO Williams Kornelia Allergan United Kingdom Yousry Asamaa Astra Travel Egypt