LORENZ userBridge Presentations · LORENZ userBridge Presentations . by Year Speaker Organization...
Transcript of LORENZ userBridge Presentations · LORENZ userBridge Presentations . by Year Speaker Organization...
LORENZ userBridge Presentations by Year Speaker Organization Topic
2003 Dr. Oliver Denk Scil Biomedicals Case Study: Choosing a Submission Management System for a Biotech Company
Ralph Geiger Documentum docuBridge & More: Enterprise Content Management in Life Sciences
Dr. Volker Geiss Bayer Healthcare AG Case Study: Challenges and Experiences in Report Management for Toxicology
Dr. Heinrich Hambloch GITP Software Quality Management in a Regulated Environment
Sven Harmsen Fujisawa Case Study: A Submission and Document Management System in an International Organisation
Dr. Lothar Höniger Berlin Chemie Case Study: Electronic Submission Experience in Central/Eastern European and Asian Countries
Dr. Lars Johannsen Bayer Healthcare AG Case Study: Lab Journal Archiving in a Pharmaceutical Research Organization
Stephen Kern SNBL e-Submissions in Japan
Dr. Sebastian Knieps LionPharm Regulatory Consulting GmbH
docuBridge & More: Submission Tracking with docuBridge
André Koppany Adobe Systems GmbH Intelligent Document Architecture within the Adobe Environment
Dr. Klaus Menges BfArM An Authority View on Electronic Submissions
The Future of Electronic Communication with Submission Relevant Documentation
© LORENZ Life Sciences Group 1
LORENZ userBridge Presentations by Year Speaker Organization Topic
2003 Dr. Klaus Menges BfArM Authority Case Study: A Process Management System based on docuBridge
Dr. Andreja Orazem Slovenian Institute of Pharmacy and Drug Research
Authority Case Study: Implementation of a Dossier Management System
Dr. Andreas Petermann 3M ESPE Case Study: docuBridge Implementation in an ISO9001/ISO13485/GMP Regulated Environment
Dr. Detlev Rhäsa LORENZ Life Sciences Group docuBridge Up Close and Personal: A Panel Discussion,
Akira Yamaguchi LORENZ Life Sciences Group The new Service Pack and Future Direction of docuBridge
© LORENZ Life Sciences Group 2
LORENZ userBridge Presentations by Year Speaker Organization Topic
2004 Kent Briggs LORENZ Life Sciences Group docuBridge Customer Product Portal
Pedrag Denkovski Apotex, Inc. Submission Management Requirements for the Generics Industry
Hiroji Emoto Digital Media System, Co., Ltd. CTD/eCTD Status in Japan
Dr. Heinrich Hambloch GITP 21 CFR Part 11 - The Changes & Impact
Sven Harmsen Fujisawa Case Study: Maintaining the Validated State of docubridge
Examining the Benefits of Electronic Publishing
Dr. Lothar Höniger Berlin Chemie Electronic submission experiences in Central & Eastern European and Asian countries
Raoul-A. Lorenz LORENZ Life Sciences Group EURS Project: Scope & Status
Charles Mathis Newbook Parallels to other initiatives & lessons learned
Dr. Klaus Menges BfArM Experiences Reviewing eCTDs, Pitfalls & how they were addressed, PIMS and other European initiatives
Stephan Montag Dr. Falk Pharma GmbH Case Study: Retrospective Validation of docuBridge
Dr. Jürgen Regenold Dr. Regenold GmbH docuBridge.ASP
© LORENZ Life Sciences Group 3
LORENZ userBridge Presentations by Year Speaker Organization Topic
2004 Dr. Olaf Schoepke LORENZ Life Sciences Group Validation: From Risk Analysis to Compliance
Submission Management: Much more than just Document Management
Alexander Stapf LORENZ Life Sciences Group Live presentation of docuBridge.ASP
Dr. Marko Vitas ARSZMP Slovenia Status of CTDs / eCTDs in Central Europe
Akira Yamaguchi LORENZ Life Sciences Group docuBridge: New Features in v3.6 and beyond
© LORENZ Life Sciences Group 4
LORENZ userBridge Presentations by Year Speaker Organization Topic
2005 Michael Abernathy QLT USA Small Biotech Company Goes Electronic - Experience with the FDA using docuBridge
David Cornwell KCentrix Software PleaseReview - Collaborative Document Review and Authoring
Dr. Chieu Diep NOMA Norway docuBridge – Assessors’ Experiences
Dr. Albert Edwards TAP Pharmaceutical Products, Inc.
TAP Meets docuBridge: Experiences with the FDA
Dr. Kurt Eisinger Igeneon AG Managing Due Diligence with docuBridge
Hiroji Emoto Digital Media System Co., Ltd. eCTD Experience in Japan
Dr. Lothar Höniger Berlin-Chemie AG (Menarini Group)
e-Submission as a Tool For Daily Regulatory Challenges
Dr. Alexander Kainz Fresenius-Biotech GmbH Clinical Trial Applications and Study Tagging Files: Expectations & Reality
Dr. Sebastian Knieps LionPharm Regulatory Consulting GmbH
Practical Regulatory Requirements
Queenia Lee Apotex, Inc. Apotex & the eCTD: Learnings, Experience and the Future
Andrew Marshall Virtual Regulatory Services PIM – European Requirements
Charles Mathis LORENZ Newbook, Inc. SPL/PIM Solution: labelBridge
© LORENZ Life Sciences Group 5
LORENZ userBridge Presentations by Year Speaker Organization Topic
2005 Dr. Klaus Menges BfArM eCTD: First-hand Experience in Germany
Konrad Moser Adobe Systems GmbH Using the Digital Signature in the Life Science Field
Dr. Jürgen Regenold Dr. Regenold GmbH docuBridge.ASP - Setup, Validation and Spread-out in a European Regulatory Affairs Network: RegulanetTM
Robert Scharinger BMGF Austria Process of the eCTD in the Austrian Authoritiy
Akira Yamaguchi & Andreas Zapf
LORENZ Life Sciences Group docuBridge: New Features & the Future
Dr. Matthias Zimmermann Merz Pharmaceuticals GmbH Daily Tasks and How They Are Supported with drugTrack
Dr. Marko Lange SAP Life Sciences Comprehensive and compliant document management with SAP for Life Sciences
© LORENZ Life Sciences Group 6
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 Life Sciences Group 7
LORENZ userBridge Presentations by Year Speaker Organization Topic
2006 Charles Mathis LORENZ Life Sciences Group Introducing LORENZ’ New eCTD Validator
Jeremy Nutall International Partnership for Microbicides (IPM)
HIV/Microbicides Project: Generating & Managing CTAs
Dr. Olaf Schoepke LORENZ Life Sciences Group eCTD & Life Cycle Management Issues
Dr. Maren von Fritschen PharmaLex GmbH Electronic Submission in the EU - Practical Experience with the New Decentralized Procedure
Akira Yamaguchi LORENZ Life Sciences Group docuBridge Development 2007
Andreas Zapf STADA Arzneimittel GmbH eCTD from a Generic’s Point of View
© LORENZ Life Sciences Group 8
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 Life Sciences Group 9
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 Life Sciences Group 10
LORENZ userBridge Presentations by Year Speaker Organization Topic
2008 Glenn Austin Health Canada Update on ICH & RPS from a Health Canada Perspective
Antoinette Azevedo e-SubmissionsSolutions.com How to Get Started on the Road to eCTD
Karel Bastiaans & Gina Galligani
Iperion IS B.V. Bridging Regulatory and Logistics Data: Benefits of the Marionette Matrix System
Karel Bastiaanssen & Imre Szabo
Iperion IS B.V. & Pronova BioPharm Norge AS
Pronova BioPharm Norge AS
Dr. Dietmar Böcker Bayer Healthcare AG eCTD in the MRP/DCP - Domesticate the Beast using the latest Guidance
Vianney Caron Health Canada e-Submissions at Health Canada
Dr. Oliver Denk PARI Pharma GmbH How ELO and docuBridge® became Partners
Peter Duff Adlib Software Accelerate Profitability by Streamlining Regulatory Publishing
Dr. Albert Edwards Takeda Global Research & Development Center, Inc.
Submissions Efficiency: Removing Submissions from the Critical Path to Market
Dr. Stefanie Frank YES Pharmaceutical Development Services GmbH
The eCTD and the Belgian Validator: Challenge !?
Dr. Sebastian Knieps LionPharm Regulatory Consulting GmbH
Managing Your Submission Activities in drugTrack
Dr. Jörg Lautz Grünenthal GmbH Submission Management - Challenges for Global Regulatory Affairs Headquarters: Multinational, Lifecycle Management, Document Management
© LORENZ Life Sciences Group 11
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 Life Sciences Group 12
LORENZ userBridge Presentations by Year Speaker Organization Topic
2009 Topia Banerji Bayer Corporation USA LCM System Migration
Dr. Dietmar Böcker Bayer Healthcare AG The New EU Variation Guideline and the eCTD: Starting to Think Horizontally
Dr. Christian Dinter Bayer HealthCare AG eCTD Lifecycle Management in an Mutual Recognition Procedure
Hiroji Emoto Digital Media System, Co., Ltd. I’ll be back! - since 2007
S. Frederiksen DITA Exchange Content Technologies ApS
Sven Harmsen e-Dra Harmsen eCTD and EDMS Process Improvement Opportunities with docuBridge
Karl-Heinz Loebel PharmaLex GmbH The Taming of the eCTD - How Industry Copes With the Challenges of e-Submissions
Scott Mackey Adlib Software Real-world Submission Publishing Optimizing your PDF Output
Charles Mathis LORENZ Life Sciences Group RPS - The New eCTD Format
Dr. Klaus Menges BfArM Update on European Telematic Implementation Group e-Submission & Development of RPS/eCTD NMV
Inge Neubauer & Elke Klein
NDA Regulatory Service GmbH Optimizing Global Submission Management - from first draft to final submission
David Obranovic JAZMP e-Submissions JAZMP point of view
© LORENZ Life Sciences Group 13
LORENZ userBridge Presentations by Year Speaker Organization Topic
2009 Maciej Piwowarski & Bartosz Mazurowski
Polpharma S.A. Implementation of eCTD in POLPHARMA
Franz Schuller AGES PharmMed Austria Managing eCTDs & Electronic Submissions at AGES – Progress Report
Sibylle Teuchmann Exalon GmbH Parallel EU / US Submission – Practical Experience from a Service Provider
© LORENZ Life Sciences Group 14
LORENZ userBridge Presentations by Year Speaker Organization Topic
2010 Harald Binder Austrian Agency for Health and Food Safety
Managing eCTDs & Electronic Submissions at AGES – Progress Report 2010
Dr. Michael Braun Exalon GmbH Switching from Paper/NeeS to eCTD: The importance role of baseline eCTDs
Vianney Caron Health Canada Update on e-Submission at Health Canada
Betty Cory Regxia Inc. eCTD in Canada
Ron de Boer Astellas Europe R&D CH M1 v.1.0.x - Experiences from Industry Perspective
Dr. Christian Dinter Bayer HealthCare AG Efficient eCTD compilation with DB 3.6: Reuse of outline components
Shelley Drost Bayer Health Care USA Migration to docuBridge 3.6 (a North American Perspective)
Dr. Andreas Franken German Medicines Manufacturers' Association
PIM Project
Dr. Klaus Menges BfArM How do Agencies review eCTD's? What do they want to see more of, and less of?
Dr. Martin Moxham i-Regulatory Ltd. RPS - Update & Status of Regulated Product Submission
Dr. Michaela Peruci Gebro Pharma GmbH Consequences of the New Regulations for Variations
Dr. Ursula Schickel Merz Pharmaceuticals GmbH Introducing eCTD in a middle-size Pharma Company
© LORENZ Life Sciences Group 15
LORENZ userBridge Presentations by Year Speaker Organization Topic
2010 Jörg Schnitzler Astellas Europe R&D eCTD LCM Hints & Tips
© LORENZ Life Sciences Group 16
LORENZ userBridge Presentations by Year Speaker Organization Topic
2011 Christophe Benninghoff NextDocs Corporation Best Practices in Regulat. Document Management to Ensure Compliant eSubmissions
Gabriela Billig LORENZ Life Sciences Group Regulatory Life Cycle Management using LORENZ drugTrack
Vianney Caron Health Canada Moving Forward with the eCTD at Health Canada
Ron de Boer Astellas Europe B.V. Coordinating Remote Sites and Relative Submission Documents
Beate Kienzler Dr. Regenold GmbH How to Use External Support for eCTD Preparation
Dr. Sebastian Knieps LionPharm Regulatory Consulting GmbH
Implementation of the New Legislation on Pharmacovigilance - Impact on Regulatory Data Management
Scott Mackey Adlib Software Populating Your eCTD – Submission Document Rendering
Charles Mathis LORENZ Life Sciences Group New FDA Validation Criteria
Fiona McLeod EDQM Implementation of LORENZ docuBridgein Certification of Substances Division at EDQM
Dr. Klaus Menges BfArM Implementation of EU eCTD ValidationCriteria
Robert Molzahn EXCELLA GmbH ASMF/DMF in eCTD Format
Helen Ribbans B&H Consulting Services, Inc. Facilitation of FDA Meetings via eCTD, (a North American Perspective)
© LORENZ Life Sciences Group 17
LORENZ userBridge Presentations by Year Speaker Organization Topic
2011 Henriette Vienings & Robin Daniel
MRA Regulatory Consultants (Pyt) Ltd.
Marketing Medicines in ZA and Southern Africa
Dr. Maren von Fritschen PharmaLex GmbH AMNOG – “Nutzendossier” in Electronic Format – Critical Aspects
© LORENZ Life Sciences Group 18
LORENZ userBridge Presentations by Year Speaker Organization Topic
2012 Saleh Al-Zomia SPIMACO Corporation GCC & SFDA eCTD Strategy
Dr. Dietmar Böcker Bayer HealthCare AG Worldwide dB Operations
Vianney Caron Health Canada Update on e-Submissions and Revised Regional Module 1 at Health Canada
Maike Diepen-Engisch YES Pharmaceutical Development Services GmbH
Good Regulatory Practice - a new emerging concept
Bryan Ennis NextDocs Corporation ETICS III
Jeffery Forbes Brand Adlib Software The art of avoiding the ‚Resubmit‘ - Updated PDF Validation requirements in FDA eCTD 2.1
Ken Hayward Qumas Ltd. Managing Regulatory Content with SharePoint 2010 – Challenges and Opportunities
Kevin Horan Irish Medicines Board CESP, Central European Submission Portal
Dawn Kelly Johnson & Johnson Consumer Companies, Inc.
Document Tracking Dashboard Concept
Karl-Heinz Loebel PharmaLex GmbH XEVPRM/XEVMPD – THE DAYS AFTER JULY 2nd 2012
Dr. Andrew Marr Marr Consultancy Ltd. EVMPD Update
Dr. Salma Michor Michor Consulting & Trade Services GmbH
Regulatory Professionals: Knowledgeable, Vital, Valued
© LORENZ Life Sciences Group 19
LORENZ userBridge Presentations by Year Speaker Organization Topic
2012 Ericka Moore Solabs Inc. eCTD and eQMS: How Solutions work together in a Life Sciences Company
Sibylle Teuchmann Exalon GmbH Results of RPS / eCTD 4.0 Survey - Potential Impact on eSubmission in EU/US
Hans van Bruggen eCTDconsultancy B.V. Develop your own! Business drivers to support multiple international standards
© LORENZ Life Sciences Group 20
LORENZ userBridge Presentations by Year Speaker Organization Topic
2013 David Cornwell PleaseTech Ltd. The document collaboration maturity model
Dr. Markus Dehnhardt Kohne Pharma GmbH Interdependencies of Pharmacovigilance and Regulatory Affairs
Dr. Albert Edwards S. Albert Edwards, PharmD Ltd. Creating a Successful Business Case for a Comprehensive Regulatory Information Management System
Bryan Ennis Veeva Systems, Inc. Validation and Compliance in the Cloud
Jeffery Forbes Brand Adlib Software Achieving Success Through Automated PDF Document Level Publishing
Christian Kaas LORENZ Life Sciences Group LORENZ Automator: Improving Regulatory Affairs Processes
David Margett Factorytalk Co., Ltd. Regulatory Picture in ASEAN
Dr. Andrew Marr Marr Consultancy Ltd. xEVMPD and IDMP Update
Dr. Klaus Menges BfArM EU IT Governance Structure
Ganesh Parkar Tata Consultancy Services (TCS) Regulatory Affairs Services - Case studies on Regulatory outsourcing
Irena Pastorekova Health Canada Update on e-Submissions at Health Canada
Günter Rodenkirchen Optimal Systems Vertriebsgesellschaft mbH
The Extended Document Life Cycle: Understanding the True Complexity of the Information Flow
© LORENZ Life Sciences Group 21
LORENZ userBridge Presentations by Year Speaker Organization Topic
2013 Alfons Schlömer Bayer Business Services GmbH System Upgrades: Moving to Production of a Global System - Technical and Organizational Challenges
Sibylle Teuchmann Exalon GmbH Electronic Submission Gateways FDA, EMA, CESP Principles and Experience
Rik van Mol Veeva Systems, Inc. How the Real Cloud is Revolutionizing Life Sciences Content Management
Henriette Vienings MRA Regulatory Consultants (Pyt) Ltd.
eCTD Implementation in South Africa
Akira Yamaguchi LORENZ Life Sciences Group RPS: An Update from Behind the Scenes
© LORENZ Life Sciences Group 22
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
Jillian Lee Bayer Healthcare AG The NDA Marriage
© LORENZ Life Sciences Group 23
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 Life Sciences Group 24
LORENZ userBridge Presentations by Speaker Year Organization Topic
Michael Abernathy 2005 QLT USA Small Biotech Company Goes Electronic - Experience with the FDA using docuBridge
Rainer Albert 2006 Medigene AG Case Study: Document Authoring & Management
Saleh Al-Zomia 2012 SPIMACO Corporation GCC & SFDA eCTD Strategy
Caroline Auriche 2006 AFSSAPS France Moving from Paper to Electronic Process in an Agency
2007 AFSSAPS France Moving From Paper to Electronic Submissions in an European Agency
Glenn Austin 2008 Health Canada Update on ICH & RPS from a Health Canada Perspective
Antoinette Azevedo 2006 e-SubmissionsSolutions.com Preparing to Submit an eCTD - Key Steps to Take Before Submission to Authority
2007 e-SubmissionsSolutions.com Practical Experience with docuBridge.ASP in e-Submissions Outsourcing
2008 e-SubmissionsSolutions.com How to Get Started on the Road to eCTD
Topia Banerji 2009 Bayer Corporation USA LCM System Migration
Prof Dr. Rolf Bass 2007 Challenges in the EU for Marketing Authorization of Medicinal Products
© LORENZ Life Sciences Group 25
LORENZ userBridge Presentations by Speaker Year Organization Topic
Karel Bastiaanssen 2008 Iperion IS B.V. Bridging Regulatory and Logistics Data: Benefits of the Marionette Matrix System
2008 Iperion IS B.V. Pronova BioPharm Norge AS
2014 Iperion IS B.V. Cloud Computing For Life Sciences - What Is There To Know
Christophe Benninghoff 2011 NextDocs Corporation Best Practices in Regulat. Document Management to Ensure Compliant eSubmissions
Jason Berning 2014 LORENZ Life Sciences Group What’s new in LORENZ docuBridge … and how can it help me?
Gabriela Billig 2011 LORENZ Life Sciences Group Regulatory Life Cycle Management using LORENZ drugTrack
Harald Binder 2010 Austrian Agency for Health and Food Safety
Managing eCTDs & Electronic Submissions at AGES – Progress Report 2010
Dr. Phillip Birch 2007 Fulcrum Pharma PLC Producing Quality Regulatory Documentation in a Services Environment
Dr. Dietmar Böcker 2007 Bayer Healthcare AG eCTD Specification 3.3.3: How Will It Impact Your Environment?
2008 Bayer Healthcare AG eCTD in the MRP/DCP - Domesticate the Beast using the latest Guidance
2009 Bayer Healthcare AG The New EU Variation Guideline and the eCTD: Starting to Think Horizontally
2012 Bayer HealthCare AG Worldwide dB Operations
© LORENZ Life Sciences Group 26
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 Life Sciences Group 27
LORENZ userBridge Presentations by Speaker Year Organization Topic
David Cornwell 2005 KCentrix Software PleaseReview - Collaborative Document Review and Authoring
2006 PleaseTech Ltd. Case Study: Document Authoring & Management
2013 PleaseTech Ltd. The document collaboration maturity model
Betty Cory 2010 Regxia Inc. eCTD in Canada
Robin Daniel 2011 MRA Regulatory Consultants (Pyt) Ltd.
Marketing Medicines in ZA and Southern Africa
Ron de Boer 2010 Astellas Europe R&D CH M1 v.1.0.x - Experiences from Industry Perspective
2011 Astellas Europe B.V. Coordinating Remote Sites and Relative Submission Documents
2014 Astellas Pharma Europe B.V. Approved Server Program via LORENZ.ASP
Dr. Markus Dehnhardt 2013 Kohne Pharma GmbH Interdependencies of Pharmacovigilance and Regulatory Affairs
Dr. Oliver Denk 2003 Scil Biomedicals Case Study: Choosing a Submission Management System for a Biotech Company
2008 PARI Pharma GmbH How ELO and docuBridge® became Partners
Pedrag Denkovski 2004 Apotex, Inc. Submission Management Requirements for the Generics Industry
© LORENZ Life Sciences Group 28
LORENZ userBridge Presentations by Speaker Year Organization Topic
Dr. Chieu Diep 2005 NOMA Norway docuBridge – Assessors’ Experiences
Maike Diepen-Engisch 2012 YES Pharmaceutical Development Services GmbH
Good Regulatory Practice - a new emerging concept
Dr. Christian Dinter 2009 Bayer HealthCare AG eCTD Lifecycle Management in an Mutual Recognition Procedure
2010 Bayer HealthCare AG Efficient eCTD compilation with DB 3.6: Reuse of outline components
Dr. Andre Dorochevsky 2006 Fresenius-Biotech GmbH eINDs and Study Tagging Files - Challenges
Shelley Drost 2010 Bayer Health Care USA Migration to docuBridge 3.6 (a North American Perspective)
Peter Duff 2008 Adlib Software Accelerate Profitability by Streamlining Regulatory Publishing
Dr. Albert Edwards 2005 TAP Pharmaceutical Products, Inc.
TAP Meets docuBridge: Experiences with the FDA
2006 TAP Pharmaceutical Products, Inc.
Life Cycle Management - Experiences with the FDA
2008 Takeda Global Research & Development Center, Inc.
Submissions Efficiency: Removing Submissions from the Critical Path to Market
2013 S. Albert Edwards, PharmD Ltd. Creating a Successful Business Case for a Comprehensive Regulatory Information Management System
Elsmari Eggers 2014 LORENZ Life Sciences Group What’s new in LORENZ docuBridge … and how can it help me?
© LORENZ Life Sciences Group 29
LORENZ userBridge Presentations by Speaker Year Organization Topic
Dr. Kurt Eisinger 2005 Igeneon AG Managing Due Diligence with docuBridge
Hiroji Emoto 2004 Digital Media System, Co., Ltd. CTD/eCTD Status in Japan
2005 Digital Media System Co., Ltd. eCTD Experience in Japan
2006 Digital Media System, Co., Ltd. Challenge to Real eCTD in Japan
2007 Digital Media System Co., Ltd Japanese eCTD Lifecycle Experience – The Importance of Utilizing Not Only the Human Being But Also the Tool
2009 Digital Media System, Co., Ltd. I’ll be back! - since 2007
Bryan Ennis 2012 NextDocs Corporation ETICS III
2013 Veeva Systems, Inc. Validation and Compliance in the Cloud
Xiaojing Fan 2014 Bayer Healthcare AG E2E eSubmission EU Concept
Jeffery Forbes Brand 2012 Adlib Software The art of avoiding the ‚Resubmit‘ - Updated PDF Validation requirements in FDA eCTD 2.1
2013 Adlib Software Achieving Success Through Automated PDF Document Level Publishing
Dr. Stefanie Frank 2008 YES Pharmaceutical Development Services GmbH
The eCTD and the Belgian Validator: Challenge !?
© LORENZ Life Sciences Group 30
LORENZ userBridge Presentations by Speaker Year Organization Topic
Dr. Andreas Franken 2010 German Medicines Manufacturers' Association
PIM Project
S. Frederiksen 2009 DITA Exchange Content Technologies ApS
Gina Galligani 2008 Iperion IS B.V. Bridging Regulatory and Logistics Data: Benefits of the Marionette Matrix System
Dr. Barbara Gansewendt 2014 Bayer Healthcare AG E2E eSubmission EU Concept
Ralph Geiger 2003 Documentum docuBridge & More: Enterprise Content Management in Life Sciences
Dr. Volker Geiss 2003 Bayer Healthcare AG Case Study: Challenges and Experiences in Report Management for Toxicology
Karin Gröndahl 2006 MPA Sweden eCTD - Reflections from an Authority’s Viewpoint
Mohit Gupta 2014 Tata Consultancy Services Ltd. (TCS)
RIM - What makes up RIM and where is it headed?
Dr. Heinrich Hambloch 2003 GITP Software Quality Management in a Regulated Environment
2004 GITP 21 CFR Part 11 - The Changes & Impact
Terry Hardin 2007 IBM Software Group Implementation Plans for RPS and Future Directions
2007 IBM Software Group The HL7 Regulated Product Submission Standard – Similarities and Differences from the eCTD
© LORENZ Life Sciences Group 31
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
Evolution of Current eCTD Processes
© LORENZ Life Sciences Group 32
LORENZ userBridge Presentations by Speaker Year Organization Topic
Dr. Kirsten Jacobs 2014 PharmaLex GmbH Outsourcing Regulatory Activities – Which Model to Choose?
Päivi Jeronen 2007 Santen Oy eCTD in Decentralized Procedure – Practical Experience
Dr. Lars Johannsen 2003 Bayer Healthcare AG Case Study: Lab Journal Archiving in a Pharmaceutical Research Organization
Christian Kaas 2013 LORENZ Life Sciences Group LORENZ Automator: Improving Regulatory Affairs Processes
Dr. Alexander Kainz 2005 Fresenius-Biotech GmbH Clinical Trial Applications and Study Tagging Files: Expectations & Reality
2007 Fresenius Biotech GmbH The Key Role of Document Chain Management for Successful Publishing
Dawn Kelly 2012 Johnson & Johnson Consumer Companies, Inc.
Document Tracking Dashboard Concept
Stephen Kern 2003 SNBL e-Submissions in Japan
Beate Kienzler 2011 Dr. Regenold GmbH How to Use External Support for eCTD Preparation
2014 Dr. Regenold GmbH Using the EMA Gateway & CESP for Electronic Submissions
Elke Klein 2009 NDA Regulatory Service GmbH Optimizing Global Submission Management - from first draft to final submission
© LORENZ Life Sciences Group 33
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 Life Sciences Group 34
LORENZ userBridge Presentations by Speaker Year Organization Topic
Queenia Lee 2005 Apotex, Inc. Apotex & the eCTD: Learnings, Experience and the Future
Jillian Lee 2014 Bayer Healthcare AG The NDA Marriage
Karl-Heinz Loebel 2009 PharmaLex GmbH The Taming of the eCTD - How Industry Copes With the Challenges of e-Submissions
2012 PharmaLex GmbH XEVPRM/XEVMPD – THE DAYS AFTER JULY 2nd 2012
Raoul-A. Lorenz 2004 LORENZ Life Sciences Group EURS Project: Scope & Status
Scott Mackey 2009 Adlib Software Real-world Submission Publishing Optimizing your PDF Output
2011 Adlib Software Populating Your eCTD – Submission Document Rendering
David Margett 2013 Factorytalk Co., Ltd. Regulatory Picture in ASEAN
Dr. Andrew Marr 2012 Marr Consultancy Ltd. EVMPD Update
2013 Marr Consultancy Ltd. xEVMPD and IDMP Update
2014 Marr Consultancy Ltd. Implementation of IDMP (Identification of Medicinal Products) is coming: Strategies for making the Business Case
Andrew Marshall 2005 Virtual Regulatory Services PIM – European Requirements
© LORENZ Life Sciences Group 35
LORENZ userBridge Presentations by Speaker Year Organization Topic
Charles Mathis 2004 Newbook Parallels to other initiatives & lessons learned
2005 LORENZ Newbook, Inc. SPL/PIM Solution: labelBridge
2006 LORENZ Life Sciences Group Introducing LORENZ’ New eCTD Validator
2006 LORENZ Life Sciences Group labelBridge Update: SPL and Beyond
2007 LORENZ Life Sciences Group Advanced eCTD LCM – How To Handle Real-life Complexities in today’s eCTD
2008 LORENZ Life Sciences Group LORENZ‘ QM System: Directions, Validations, GAMP5
2009 LORENZ Life Sciences Group RPS - The New eCTD Format
2011 LORENZ Life Sciences Group New FDA Validation Criteria
Bartosz Mazurowski 2009 Polpharma S.A. Implementation of eCTD in POLPHARMA
Fiona McLeod 2011 EDQM Implementation of LORENZ docuBridgein Certification of Substances Division at EDQM
© LORENZ Life Sciences Group 36
LORENZ userBridge Presentations by Speaker Year Organization Topic
Dr. Klaus Menges 2003 BfArM An Authority View on Electronic Submissions
2003 BfArM Authority Case Study: A Process Management System based on docuBridge
2003 BfArM The Future of Electronic Communication with Submission Relevant Documentation
2004 BfArM Experiences Reviewing eCTDs, Pitfalls & how they were addressed, PIMS and other European initiatives
2005 BfArM eCTD: First-hand Experience in Germany
2008 BfArM eSubmissions in Europe – Report from TIGes and its Subgroups
2009 BfArM Update on European Telematic Implementation Group e-Submission & Development of RPS/eCTD NMV
2010 BfArM How do Agencies review eCTD's? What do they want to see more of, and less of?
2011 BfArM Implementation of EU eCTD ValidationCriteria
2013 BfArM EU IT Governance Structure
2014 BfArM HMA eSubmission Roadmap
Vishal Mhatre 2014 Tata Consultancy Services Ltd. (TCS)
RIM - What makes up RIM and where is it headed?
© LORENZ Life Sciences Group 37
LORENZ userBridge Presentations by Speaker Year Organization Topic
Dr. Salma Michor 2012 Michor Consulting & Trade Services GmbH
Regulatory Professionals: Knowledgeable, Vital, Valued
Robert Molzahn 2011 EXCELLA GmbH ASMF/DMF in eCTD Format
Stephan Montag 2004 Dr. Falk Pharma GmbH Case Study: Retrospective Validation of docuBridge
Ericka Moore 2012 Solabs Inc. eCTD and eQMS: How Solutions work together in a Life Sciences Company
Konrad Moser 2005 Adobe Systems GmbH Using the Digital Signature in the Life Science Field
Dr. Martin Moxham 2008 i-Regulatory Ltd. Practical Experience with Migration of Product Information from MS Word to PIM XML
2010 i-Regulatory Ltd. RPS - Update & Status of Regulated Product Submission
Denis Mulhall 2014 Health Canada Assessment of docuBridge as a Corporate Repository@Health Canada
Inge Neubauer 2009 NDA Regulatory Service GmbH Optimizing Global Submission Management - from first draft to final submission
Jeremy Nutall 2006 International Partnership for Microbicides (IPM)
HIV/Microbicides Project: Generating & Managing CTAs
David Obranovic 2009 JAZMP e-Submissions JAZMP point of view
Denise Oliveira 2007 Genzyme Corporation USA End-to-end Electronic Submissions and Review Environment – What Does This Mean For the Industry?
© LORENZ Life Sciences Group 38
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
© LORENZ Life Sciences Group 39
LORENZ userBridge Presentations by Speaker Year Organization Topic
Robert Scharinger 2005 BMGF Austria Process of the eCTD in the Austrian Authoritiy
2007 BMGF Austria Effects of Healthcard Systems in the Pharmaceutical Industry
Dr. Ursula Schickel 2010 Merz Pharmaceuticals GmbH Introducing eCTD in a middle-size Pharma Company
Alfons Schlömer 2013 Bayer Business Services GmbH System Upgrades: Moving to Production of a Global System - Technical and Organizational Challenges
Jörg Schnitzler 2007 Merck Serono GmbH Simultaneous Preparation of eCTD and Paper for Submissions in the Centralised Procedure
2010 Astellas Europe R&D eCTD LCM Hints & Tips
Dr. Olaf Schoepke 2004 LORENZ Life Sciences Group Submission Management: Much more than just Document Management
2004 LORENZ Life Sciences Group Validation: From Risk Analysis to Compliance
2006 LORENZ Life Sciences Group eCTD & Life Cycle Management Issues
Franz Schuller 2007 AGES PharmMed Austria Status and Progress at AGES PharmMed
2008 AGES PharmMed Austria Managing eCTDs & Electronic Submissions at AGES
2009 AGES PharmMed Austria Managing eCTDs & Electronic Submissions at AGES – Progress Report
© LORENZ Life Sciences Group 40
LORENZ userBridge Presentations by Speaker Year Organization Topic
Prof Dr. Harald Schweim 2007 University of Bonn European Electronic Document Management Systems (EEDMS)
Michiel Stam 2014 Qdossier B.V Using Thesaurus to Capture IMPD (Investigational Medicinal Product Dossier) Topics
Alexander Stapf 2004 LORENZ Life Sciences Group Live presentation of docuBridge.ASP
Imre Szabo 2008 Pronova BioPharm Norge AS Pronova BioPharm Norge AS
Yasuo Takeuchi 2008 Chugai Pharmaceutical Co., Ltd. Experiences of eCTD Submission for PMDA: Japan
Sibylle Teuchmann 2009 Exalon GmbH Parallel EU / US Submission – Practical Experience from a Service Provider
2012 Exalon GmbH Results of RPS / eCTD 4.0 Survey - Potential Impact on eSubmission in EU/US
2013 Exalon GmbH Electronic Submission Gateways FDA, EMA, CESP Principles and Experience
Erik Thygesen 2008 Ferring Pharmaceuticals A/S eCTD Pilots as Key to eCTD Implementation
Hans van Bruggen 2012 eCTDconsultancy B.V. Develop your own! Business drivers to support multiple international standards
Dr. Arnold P.J. van der Marel 2008 Disphar International B.V. Challenging docuBridge® with Generic Dossier Management and e-Submissions
© LORENZ Life Sciences Group 41
LORENZ userBridge Presentations by Speaker Year Organization Topic
Rik van Mol 2013 Veeva Systems, Inc. How the Real Cloud is Revolutionizing Life Sciences Content Management
Hans van Reeuwijk 2008 Astellas Pharma Europe Astellas Adopts ASP
Henriette Vienings 2011 MRA Regulatory Consultants (Pyt) Ltd.
Marketing Medicines in ZA and Southern Africa
2013 MRA Regulatory Consultants (Pyt) Ltd.
eCTD Implementation in South Africa
Dr. Marko Vitas 2004 ARSZMP Slovenia Status of CTDs / eCTDs in Central Europe
Dr. Maren von Fritschen 2006 PharmaLex GmbH Electronic Submission in the EU - Practical Experience with the New Decentralized Procedure
2007 PharmaLex GmbH Streamlining Business Processes with the eCTD – Hurdles and Benefits, Options and Challenges, Success and Failure
2011 PharmaLex GmbH AMNOG – “Nutzendossier” in Electronic Format – Critical Aspects
Jeff Wilson 2008 Submission Consulting Group Case Study docuBridge® in a Small Company Setting
© LORENZ Life Sciences Group 42
LORENZ userBridge Presentations by Speaker Year Organization Topic
Akira Yamaguchi 2003 LORENZ Life Sciences Group The new Service Pack and Future Direction of docuBridge
2004 LORENZ Life Sciences Group docuBridge: New Features in v3.6 and beyond
2005 LORENZ Life Sciences Group docuBridge: New Features & the Future
2006 LORENZ Life Sciences Group docuBridge Development 2007
2007 LORENZ Life Sciences Group docuBridge Development 2007+
2008 LORENZ Life Sciences Group docuBridge® 5.0
2013 LORENZ Life Sciences Group RPS: An Update from Behind the Scenes
2014 LORENZ Life Sciences Group New FDA M1 specifications Q4 2014
Andreas Zapf 2005 LORENZ Life Sciences Group docuBridge: New Features & the Future
2006 STADA Arzneimittel GmbH eCTD from a Generic’s Point of View
Dr. Matthias Zimmermann 2005 Merz Pharmaceuticals GmbH Daily Tasks and How They Are Supported with drugTrack
© LORENZ Life Sciences Group 43