13th DIA Conference on European Electronic Document Management

Tutorials Wednesday, November 28, 2012

• 9:00AM - 5:00PM

  Tutorial 1: eTMF - MIGRATING FROM PAPER TRIAL MASTER FILES TO ELECTRONIC
  

  This tutorial will provide a comprehensive overview of the issues involved in implementing an electronic trial master file. In addition to covering foundation principles such as “what is the trial master file”, this interactive session will provide guidance in a wide range of related aspects, including:

  • what do the regulations say about eTMFs
  • how should documents be filed in an eTMF
  • metadata and naming conventions
  • what formats are acceptable
  • how can the eTMF be reviewed by end-users, auditors and inspectors
  • how can an eTMF support global clinical trials
  • how is the eTMF populated and maintained
  • what are the validation requirements
  • does an eTMF need electronic signatures
• 9:00AM - 5:00PM

  Tutorial 2: Data/Content Migration - Effective Migration Strategies: Understanding Bear-Traps & Honey Pots
  

  The implementation of new systems to enhance document management capabilities, establish efficiencies and better respond to regulatory needs, requires thorough planning and considerable strategic forethought if document migration is to be effective and successful. The need to maintain the integrity and (re-)usability of documents in the short-term as well as preserve them for long-term retention, means that the migration can be complex and challenging …and should never be underestimated.

  
  This interactive workshop is designed to help you understand and meet those challenges. It will

  • provide a comprehensive overview of the fundamental aspects of data migration;
  • explore considerations that need to be thought about before, during and after migration to enable best use of time and resources; and
  • evaluate options and approaches that can be used to ensure that migration ctivities progress as smoothly as possible and maximise business benefits.
    

  The focus will be on sharing practical experiences gained from actual migration projects to illustrate real-world scenarios and provide guidance on a wide range of subject areas including:

  • rationale for migration
  • planning considerations
  • designing effective strategies
  • migration tools and process
  • metadata transfer and mapping
  • testing and validation requirements
  • controls and compliance engineering
  • education, training and support
  • common mistakes/oversights

Day 1 Thursday, November 29, 2012

• 9:00AM - 10:30PM

  WELCOME AND INTRODUCTION

  
  Session Chair(s):

  • Anita M Paul
    Head of Corporate Records Management
    F. Hoffmann-La Roche AG, Switzerland
  • Hans von Bruggen
    Director and Senior RA consultant
    Ectd Consulting B.V., Netherlands

  WELCOME AND INTRODUCTION

  Speaker(s):

  • Strategy Map and Balanced Scorecard
    Dimitri Stamatiadis, PhD,MBA
    Director
    MAIA Consulting SARL, Switzerland
  • Data and Documents : new frontiers and old conundrums
    Jonathan Burd
    Solution Director
    GxPi, United Kingdom
  • Challenges to Document Management and Submission Management
    Akira Yamaguchi, MBA
    Vice President Product Development
    LORENZ Life Sciences Group, Germany
• 11:00AM - 12:30PM

  SUBMISSION PLANNING, REGISTRATION TRACKING, eCTD LIFECYCLE, MODULE 3 LIFECYCLE, TEMPLATES

  
  Session Chair(s):

  • Dimitri Stamatiadis, PhD,MBA
    Director
    MAIA Consulting SARL, Switzerland

  Speaker(s):

  • Effective Submission Planning and Life Cycle Management
    Dana Hoehne
    Regulatory Informatics and Submission Management
    Merck Serono, Germany
  • How Document Templates can Facilitate or Prohibit Multipurpose of Documents
    Michiel Stam
    Manager Regulatory Operation
    Qdossier B.V., Netherlands
  • The Virtual Regulatory Operations Department – using external resources to respond to new agency guidance
    James Hendry
    Regulatory Operations Manager
    Liquient, United Kingdom
  • The Virtual Regulatory Operations Department – using external resources to respond to new agency guidance
    Cynthia F. Piccirillo
    Director, Global Dossier Management
    Bristol-Myers Squibb, United States
• 11:00AM - 12:30PM

  TMFs - ELECTRONIC AND PAPER LIFECYCLE MANAGEMENT

  
  Session Chair(s):

  • Eldin Rammell
    Managing Director & Principal Consultant
    Rammell Consulting Ltd, United Kingdom

  Speaker(s):

  • The digital TMF - What is holding us back?
    Jim Cook
    CEO
    Arkivum Limited, United Kingdom
  • Destroy that Paper!! Introduction of the Framework for the Destruction of Paper
    Lisa D. Mulcahy
    TMF Content Management and Process Consultant
    Mulcahy Consulting, LLC, United States
  • Automatic conversion and indexing of paper CRFs
    Thomas Hornbaek Svendsen, MS
    Principal Consultant
    NNIT A/S, Denmark
• 2:00PM - 3:30PM

  EDM INTEGRATION

  
  Session Chair(s):

  • Joris Kampmeijer
    Information Processing Department
    Medicines Evaluation Board , Netherlands

  Speaker(s):

  • Electronic Document Management Systems Exposed to Mobility
    Brian Troelsen
    Business Development Consultant
    NNIT A/S, Denmark
  • EDM Reference Model as an Integration Factor Between Sponsors and Partners
    Steve Scribner
    Principal Consultant, Life Sciences
    EMC, United States
  • An Agile Approach to Implementing Structured Content Authoring System for Clinical Documentation
    Sandrine Avaro-Coutant
    Business analyst
    Sanofi R&D - Technology and Information Management, France
• 2:00PM - 3:30PM

  eTMF REFERENCE MODEL/eTMF IMPLEMENTATION

  
  Session Chair(s):

  • Anita M Paul
    Head of Corporate Records Management
    F. Hoffmann-La Roche AG, Switzerland

  Speaker(s):

  • Critical Success Factors for eTMF Project Success
    Eldin Rammell
    Managing Director & Principal Consultant
    Rammell Consulting Ltd, United Kingdom
  • Expanding the TMF Reference Model
    Karen Jane Redding, MPharm
    Director, Global Business Development
    Phlexglobal Limited, United Kingdom
  • Quality Control and Inclusion of Third Party (CRO) Files into the Sponsor (e)TMF
    Alexander Dingenouts
    Coordinator Clinical Records Management
    Abbott Healthcare Products B.V., Netherlands
• 4:00PM - 5:30PM

  PANEL DISCUSSION - STANDARDISATION

  
  Session Chair(s):

  • Dimitri Stamatiadis, PhD,MBA
    Director
    MAIA Consulting SARL, Switzerland

  Speaker(s):

  • Karen Jane Redding, MPharm
    Director, Global Business Development
    Phlexglobal Limited, United Kingdom
  • Hans van Bruggen, MSc., MSc
    Senior Regulatory Affairs Consultant
    eCTDconsultancy B.V., Netherlands
  • Elke Schydlo
    Global Head Submission & Registration Management
    Abbott Laboratories, Germany
  • Steve Scribner
    Principal Consultant, Life Sciences
    EMC, United States
• 4:00PM - 5:30PM

  PANEL DISCUSSION - eTMF

  
  Session Chair(s):

  • Thomas Altenwerth
    Records Management Consultant
    ..., Germany

  Speaker(s):

  • Lisa D. Mulcahy
    TMF Content Management and Process Consultant
    Mulcahy Consulting, LLC, United States
  • Eldin Rammell
    Managing Director & Principal Consultant
    Rammell Consulting Ltd, United Kingdom
  • Russell Joyce
    Director & Principal Consultant
    Heath Barrowcliff Consulting Ltd, United Kingdom

Day 2 Friday, November 30, 2012

• 8:00AM - 9:30AM

  EVMPD/IDMP

  
  Session Chair(s):

  • Joris Kampmeijer
    Information Processing Department
    Medicines Evaluation Board , Netherlands

  Speaker(s):

  • Case Study Abbott
    Elke Schydlo
    Global Head Submission & Registration Management
    Abbott Laboratories, Germany
  • Experiences across Industry and Future Directions
    Andrew P. Marr, PhD
    Managing Director
    Marr Consultancy Ltd., United Kingdom
• 8:00AM - 9:30AM

  NEW EDM OPPORTUNITIES

  
  Session Chair(s):

  • Thomas Altenwerth
    Records Management Consultant
    ..., Germany

  Speaker(s):

  • Deploying eTMF (electronic trial master file) in the Cloud
    Paul Fenton, MBA,MS
    President and CEO
    Montrium Inc., Canada
  • eDMS in the Cloud – lessons learned of a biotech company
    Sven Harmsen
    Senior Consultant
    e-DRA Harmsen, Germany
  • Not just Another Portal: A Social Media Approach to Connecting Sponsors, Investigators and Patients
    Denis Cardinal
    Clinical Information and Collaboration Domain Manager
    Sanofi-Aventis, France
  • Not just Another Portal: A Social Media Approach to Connecting Sponsors, Investigators and Patients
    Guillaume Gerard
    Enterprise Program Director
    NextDocs, Germany
• 10:00AM - 11:30AM

  RPS

  
  Session Chair(s):

  • Dimitri Stamatiadis, PhD,MBA
    Director
    MAIA Consulting SARL, Switzerland

  Speaker(s):

  • RPS and eCTD
    Harv W Martens
    President
    ING America, Inc., United States
  • RPS Tools
    Joerg Schnitzler, PharmD,MSc,RPh
    Head of Regulatory Operations
    Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
  • Making RPS into eCTD4: Getting the world on board
    Joel Finkle
    Senior Strategist, Regulatory Informatics
    CSC Life Sciences, United States
• 10:00AM - 11:30AM

  CLOUD LEGAL ASPECTS AND RISK MANAGEMENT

  
  Session Chair(s):

  • Bram Van Den Brink
    Global Head Records Operation Center
    Abbott Healtcare Products B.V., Netherlands

  Speaker(s):

  • Opportunities for Cloud Computing in Regulatory Affairs
    Thomas Staedter, DrSc
    Professor for Information Technologies
    EXTEDO, Gmbh; University of Applied Sciences, Germany
  • GAMP as a Suitable Framework for Validation of Electronic Document Management Systems on Premesis and “in the Cloud”
    Keith Williams, MSc
    Founder and Chief Executive Officer
    GXPi, United Kingdom
  • Collaboration Conundrum: How to share content securely and compliantly in today’s life science industry
    Rik Van Mol
    Vice President
    Veeva Vault Europe, Spain
• 1:00PM - 2:30PM

  REGIONAL REGULATORY REQUIREMENTS

  
  Session Chair(s):

  • Hans van Bruggen, MSc., MSc
    Senior Regulatory Affairs Consultant
    eCTDconsultancy B.V., Netherlands

  Speaker(s):

  • FDA
    Gary M. Gensinger, MBA
    Deputy Director, Office of Business Informatics, CDER
    FDA, United States
  • Current Status and Perspective on Electronic Submission in China
    Peng Han
    Team Leader of Multidiscoplinary Subgroup of ICH Study Group
    Chinese Pharmacopeia Commission, China
  • Regulations for RX-products and New Classifications in Turkey
    Asli Can Agca
    Pharmacy, Department of Borderline Products
    Ministry of Health - General Directorate of Pharmaceuticals and, Turkey
• 1:00PM - 2:30PM

  LONG TERM PRESERVATION, DATA MIGRATION, INSPECTION - experience, expectations

  
  Session Chair(s):

  • Anita M Paul
    Head of Corporate Records Management
    F. Hoffmann-La Roche AG, Switzerland

  Speaker(s):

  • Record preservation in a digital age – The struggles and experiences
    Robert Purdue
    Global Head Information & Compliance Management
    Novartis Institute For Biomedical Research, Switzerland
  • Managing and automating Compliance Training records, the missing link between controlled Document Management
    Jonathan Burd
    Solution Director
    GxPi, United Kingdom
  • Pharma Initiative for Long-Term Preservation
    Pauline Sinclair
    Digital Archiving Consultant
    Tessella, United Kingdom
• 3:00PM - 4:30PM

  MEET THE REGULATORS

  
  Session Chair(s):

  • Hans van Bruggen, MSc., MSc
    Senior Regulatory Affairs Consultant
    eCTDconsultancy B.V., Netherlands

  Speaker(s):

  • FDA
    Gary M. Gensinger, MBA
    Deputy Director, Office of Business Informatics, CDER
    FDA, United States
  • Peng Han
    Team Leader of Multidiscoplinary Subgroup of ICH Study Group
    Chinese Pharmacopeia Commission, China
  • Asli Can Agca
    Pharmacy, Department of Borderline Products
    Ministry of Health - General Directorate of Pharmaceuticals and, Turkey
  • CLOSING OF CONFERENCE:
    Anita M Paul
    Head of Corporate Records Management
    F. Hoffmann-La Roche AG, Switzerland