LORENZ userBridge Presentations by Year Speaker Organization Topic
2006 Caroline Auriche AFSSAPS France Moving from Paper to Electronic Process in an Agency
Antoinette Azevedo e-SubmissionsSolutions.com Preparing to Submit an eCTD - Key Steps to Take Before Submission to Authority
Vianney Caron Health Canada Health Canada’s Perspective on eCTD Life Cycle Management
David Cornw & Rainer Albert
PleaseTech Ltd. & Medigene AG
Case Study: Document Authoring & Management
Dr. Andre Dorochevsky Fresenius-Biotech GmbH eINDs and Study Tagging Files - Challenges
Dr. Albert Edwards TAP Pharmaceutical Products, Inc.
Life Cycle Management - Experiences with the FDA
Hiroji Emoto Digital Media System, Co., Ltd. Challenge to Real eCTD in Japan
Karin Gröndahl MPA Sweden eCTD - Reflections from an Authority’s Viewpoint
Sven Harmsen Astellas Pharma GmbH eCTD Project Implementation in Europe
Dr. Sebastian Knieps LionPharm Regulatory Consulting GmbH
Regulatory Affairs Management: drugTrack
Sonja Krisam Dr. Regenold GmbH docuBridge.ASP - Setup, Validation and Spread-out in a European Regulatory Affairs Networks (regulanet®) or a Test Case for an International Company?
Charles Mathis LORENZ Life Sciences Group labelBridge Update: SPL and Beyond
LORENZ userBridge Presentations by Year Speaker Organization Topic
2007 Caroline Auriche AFSSAPS France Moving From Paper to Electronic Submissions in an European Agency
Antoinette Azevedo e-SubmissionsSolutions.com Practical Experience with docuBridge.ASP in e-Submissions Outsourcing
Prof Dr. Rolf Bass Challenges in the EU for Marketing Authorization of Medicinal Products
Dr. Phillip Birch Fulcrum Pharma PLC Producing Quality Regulatory Documentation in a Services Environment
Dr. Dietmar Böcker Bayer Healthcare AG eCTD Specification 3.3.3: How Will It Impact Your Environment?
Hiroji Emoto Digital Media System Co., Ltd Japanese eCTD Lifecycle Experience – The Importance of Utilizing Not Only the Human Being But Also the Tool
Terry Hardin IBM Software Group Implementation Plans for RPS and Future Directions
The HL7 Regulated Product Submission Standard – Similarities and Differences from the eCTD
Sven Harmsen Astellas Pharma GmbH Moving Away From the Paper-based Submission Model – How To Change Business Processes & Organisation to Benefit Most From eCTD
Lois Householder TAP Pharmaceutical Products, Inc
Evolution of Current eCTD Processes
Päivi Jeronen Santen Oy eCTD in Decentralized Procedure – Practical Experience
Dr. Alexander Kainz Fresenius Biotech GmbH The Key Role of Document Chain Management for Successful Publishing
LORENZ userBridge Presentations by Year Speaker Organization Topic
2007 Dr. Sebastian Knieps LionPharm Regulatory Consulting GmbH
Implementation of drugTrack in the Global Headquarters – A Case Study by Fresenius Medical Care (FMC)
Sonja Krisam Dr. Regenold GmbH docuBridge.ASP – Use for Documentation Management on Behalf of a Client
Raun Kupiec Genzyme Europe BV PIM and its Relationship to the eCTD
Charles Mathis LORENZ Life Sciences Group Advanced eCTD LCM – How To Handle Real-life Complexities in today’s eCTD
Denise Oliveira Genzyme Corporation USA End-to-end Electronic Submissions and Review Environment – What Does This Mean For the Industry?
Robert Scharinger BMGF Austria Effects of Healthcard Systems in the Pharmaceutical Industry
Jörg Schnitzler Merck Serono GmbH Simultaneous Preparation of eCTD and Paper for Submissions in the Centralised Procedure
Franz Schuller AGES PharmMed Austria Status and Progress at AGES PharmMed
Prof Dr. Harald Schweim University of Bonn European Electronic Document Management Systems (EEDMS)
Dr. Maren von Fritschen PharmaLex GmbH Streamlining Business Processes with the eCTD – Hurdles and Benefits, Options and Challenges, Success and Failure
Akira Yamaguchi LORENZ Life Sciences Group docuBridge Development 2007+
LORENZ userBridge Presentations by Year Speaker Organization Topic
2008 Charles Mathis LORENZ Life Sciences Group LORENZ‘ QM System: Directions, Validations, GAMP5
Dr. Klaus Menges BfArM eSubmissions in Europe – Report from TIGes and its Subgroups
Dr. Martin Moxham i-Regulatory Ltd. Practical Experience with Migration of Product Information from MS Word to PIM XML
Dr. Hannes Perschinka Gebro Pharma GmbH docuBridge® as a Tool for eSubmission & Regulatory Compliance in a medium-sized European Pharmaceutical Company
Franz Schuller AGES PharmMed Austria Managing eCTDs & Electronic Submissions at AGES
Yasuo Takeuchi Chugai Pharmaceutical Co., Ltd. Experiences of eCTD Submission for PMDA: Japan
Erik Thygesen Ferring Pharmaceuticals A/S eCTD Pilots as Key to eCTD Implementation
Dr. Arnold P.J. van der Marel Disphar International B.V. Challenging docuBridge® with Generic Dossier Management and e-Submissions
Hans van Reeuwijk Astellas Pharma Europe Astellas Adopts ASP
Jeff Wilson Submission Consulting Group Case Study docuBridge® in a Small Company Setting
Akira Yamaguchi LORENZ Life Sciences Group docuBridge® 5.0
LORENZ userBridge Presentations by Year Speaker Organization Topic
2014 Karel Bastiaanssen Iperion IS B.V. Cloud Computing For Life Sciences - What Is There To Know
Jason Berning & Elsmari Eggers
LORENZ Life Sciences Group What’s new in LORENZ docuBridge … and how can it help me?
Kent Briggs LORENZ Life Sciences Group eSubmissions in Australia
Peter Bunse fme AG Chances and limits of integrated cross functional ECM platforms in the Life Science Industry
Vianney Caron Health Canada Health Canada Transition to eCTD and non-eCTD electronic only Regulatory Activities via the Common Electronic submission Gateway (CESG)
Teerapong Cheepchol Factorytalk Co., Ltd. Preparing for first eCTD in ASEAN
Ron de Boer Astellas Pharma Europe B.V. Approved Server Program via LORENZ.ASP
Dr. Barbara Gansewendt & Xiaojing Fan
Bayer Healthcare AG E2E eSubmission EU Concept
Mohit Gupta & Vishal Mhatre
Tata Consultancy Services Ltd. (TCS)
RIM - What makes up RIM and where is it headed?
Dr. Kirsten Jacobs PharmaLex GmbH Outsourcing Regulatory Activities – Which Model to Choose?
Beate Kienzler Dr. Regenold GmbH Using the EMA Gateway & CESP for Electronic Submissions
LORENZ userBridge Presentations by Year Speaker Organization Topic
2014 Dr. Andrew Marr Marr Consultancy Ltd. Implementation of IDMP (Identification of Medicinal Products) is coming: Strategies for making the Business Case
Dr. Klaus Menges BfArM HMA eSubmission Roadmap
Denis Mulhall Health Canada Assessment of docuBridge as a Corporate Repository@Health Canada
Michiel Stam Qdossier B.V Using Thesaurus to Capture IMPD (Investigational Medicinal Product Dossier) Topics
Akira Yamaguchi LORENZ Life Sciences Group New FDA M1 specifications Q4 2014
LORENZ userBridge Presentations by Speaker Year Organization Topic
Dr. Michael Braun 2010 Exalon GmbH Switching from Paper/NeeS to eCTD: The importance role of baseline eCTDs
Kent Briggs 2004 LORENZ Life Sciences Group docuBridge Customer Product Portal
2014 LORENZ Life Sciences Group eSubmissions in Australia
Peter Bunse 2014 fme AG Chances and limits of integrated cross functional ECM platforms in the Life Science Industry
Vianney Caron 2006 Health Canada Health Canada’s Perspective on eCTD Life Cycle Management
2008 Health Canada e-Submissions at Health Canada
2010 Health Canada Update on e-Submission at Health Canada
2011 Health Canada Moving Forward with the eCTD at Health Canada
2012 Health Canada Update on e-Submissions and Revised Regional Module 1 at Health Canada
2014 Health Canada Health Canada Transition to eCTD and non-eCTD electronic only Regulatory Activities via the Common Electronic submission Gateway (CESG)
Teerapong Cheepchol 2014 Factorytalk Co., Ltd. Preparing for first eCTD in ASEAN
LORENZ userBridge Presentations by Speaker Year Organization Topic
Sven Harmsen 2003 Fujisawa Case Study: A Submission and Document Management System in an International Organisation
2004 Fujisawa Case Study: Maintaining the Validated State of docubridge
2004 Fujisawa Examining the Benefits of Electronic Publishing
2006 Astellas Pharma GmbH eCTD Project Implementation in Europe
2007 Astellas Pharma GmbH Moving Away From the Paper-based Submission Model – How To Change Business Processes & Organisation to Benefit Most From eCTD
2009 e-Dra Harmsen eCTD and EDMS Process Improvement Opportunities with docuBridge
Ken Hayward 2012 Qumas Ltd. Managing Regulatory Content with SharePoint 2010 – Challenges and Opportunities
Dr. Lothar Höniger 2003 Berlin Chemie Case Study: Electronic Submission Experience in Central/Eastern European and Asian Countries
2004 Berlin Chemie Electronic submission experiences in Central & Eastern European and Asian countries
2005 Berlin-Chemie AG (Menarini Group)
e-Submission as a Tool For Daily Regulatory Challenges
Kevin Horan 2012 Irish Medicines Board CESP, Central European Submission Portal
Lois Householder 2007 TAP Pharmaceutical Products, Inc
LORENZ userBridge Presentations by Speaker Year Organization Topic
Dr. Sebastian Knieps 2003 LionPharm Regulatory Consulting GmbH
docuBridge & More: Submission Tracking with docuBridge
2005 LionPharm Regulatory Consulting GmbH
Practical Regulatory Requirements
2006 LionPharm Regulatory Consulting GmbH
Regulatory Affairs Management: drugTrack
2007 LionPharm Regulatory Consulting GmbH
Implementation of drugTrack in the Global Headquarters – A Case Study by Fresenius Medical Care (FMC)
2008 LionPharm Regulatory Consulting GmbH
Managing Your Submission Activities in drugTrack
2011 LionPharm Regulatory Consulting GmbH
Implementation of the New Legislation on Pharmacovigilance - Impact on Regulatory Data Management
André Koppany 2003 Adobe Systems GmbH Intelligent Document Architecture within the Adobe Environment
Sonja Krisam 2006 Dr. Regenold GmbH docuBridge.ASP - Setup, Validation and Spread-out in a European Regulatory Affairs Networks (regulanet®) or a Test Case for an International Company?
2007 Dr. Regenold GmbH docuBridge.ASP – Use for Documentation Management on Behalf of a Client
Raun Kupiec 2007 Genzyme Europe BV PIM and its Relationship to the eCTD
Dr. Marko Lange 2005 SAP Life Sciences Comprehensive and compliant document management with SAP for Life Sciences
Dr. Jörg Lautz 2008 Grünenthal GmbH Submission Management - Challenges for Global Regulatory Affairs Headquarters: Multinational, Lifecycle Management, Document Management
LORENZ userBridge Presentations by Speaker Year Organization Topic
Dr. Andreja Orazem 2003 Slovenian Institute of Pharmacy and Drug Research
Authority Case Study: Implementation of a Dossier Management System
Ganesh Parkar 2013 Tata Consultancy Services (TCS) Regulatory Affairs Services - Case studies on Regulatory outsourcing
Irena Pastorekova 2013 Health Canada Update on e-Submissions at Health Canada
Dr. Hannes Perschinka 2008 Gebro Pharma GmbH docuBridge® as a Tool for eSubmission & Regulatory Compliance in a medium-sized European Pharmaceutical Company
Dr. Michaela Peruci 2010 Gebro Pharma GmbH Consequences of the New Regulations for Variations
Dr. Andreas Petermann 2003 3M ESPE Case Study: docuBridge Implementation in an ISO9001/ISO13485/GMP Regulated Environment
Maciej Piwowarski 2009 Polpharma S.A. Implementation of eCTD in POLPHARMA
Dr. Jürgen Regenold 2004 Dr. Regenold GmbH docuBridge.ASP
2005 Dr. Regenold GmbH docuBridge.ASP - Setup, Validation and Spread-out in a European Regulatory Affairs Network: RegulanetTM
Dr. Detlev Rhäsa 2003 LORENZ Life Sciences Group docuBridge Up Close and Personal: A Panel Discussion,
Helen Ribbans 2011 B&H Consulting Services, Inc. Facilitation of FDA Meetings via eCTD, (a North American Perspective)
Günter Rodenkirchen 2013 Optimal Systems Vertriebsgesellschaft mbH
The Extended Document Life Cycle: Understanding the True Complexity of the Information Flow
