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Global Pharmaceutical Regulatory Affairs Summit
Delivered as a Hybrid Event 6th - 13th April 2022
Berlin Summit: 6-8 April | Digital Experience: 11-13 AprilPresented in Central European Time (CEST)
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BERLIN SUMMIT: DAY 2 - Thur, 7 Aprkeyboard_arrow_right

BERLIN SUMMIT: DAY 2 - Thur, 7 Apr - CET/CEST (Cent Europe Summer, GMT+2)

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BERLIN SUMMIT: DAY 2 - Thur, 7 Apr - CET/CEST (Cent Europe Summer, GMT+2)

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BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 08:30 - 09:0030 mins
Morning Refreshments and Conference Registration
    BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 09:00 - 09:1515 mins
    Regulatory Information Management
    Chairperson’s Opening Remarks
      BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 09:00 - 09:1515 mins
      Global eSubmissions
      Chairperson’s Opening Remarks
        BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 09:15 - 10:0045 mins
        Regulatory Information Management
        Practical Approaches to Leveraging New and Existing RIM Systems
        • Ana Montoya Alarcon - Regulatory IT Manager, Novartis
        BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 09:15 - 10:0045 mins
        Global eSubmissions
        Progress on the Implementation of IDMP Substance Management Solution Based on IDMP Substance Model
        • Annet Rozema - Project Manager EU-SRS, Medicines Evaluation Board
        • Jean-Gonzague Fontaine - Product and Substance Master Data Lead, Vx, GSK
        BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 10:00 - 10:4545 mins
        Regulatory Information Management
        Leveraging IDMP and Available Data Connections for Business Benefit
        • Quentin Grignet - Head of Master Data Mgt. Strategy & Analytics, GSK
        BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 10:00 - 10:4545 mins
        Global eSubmissions
        Spotlight Session: Navigate Submissions Standards with Expert Guidance
          BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 10:45 - 11:1530 mins
          Networking Break
            BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 11:15 - 12:1560 mins
            Regulatory Information Management
            RIMS Roundtables: Problem-Solving Based on Company Size
            • Jason Berning - Associate Business Development Director - Regulatory Technology Solutions, IQVIA
            • Matthias Glatz - IT-Manager Regulatory Affairs, Novartis Pharma AG
            BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 11:15 - 12:1560 mins
            Global eSubmissions
            European Regulators Forum
            • Jesper Kjaer - Director of Data Analytics Centre, Co-chair HMA / EMA Big Data Steering Group, Danish Medicines Agency
            BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 12:15 - 13:3075 mins
            Networking Luncheon & Solutions Showcase
              BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 13:30 - 14:1545 mins
              Regulatory Information Management
              Case Study: RIM Strategy Towards Digital Transformation
              • Quentin Darrasse - Global Quality Manager for Regulatory Operations, F. Hoffmann - La Roche AG
              BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 13:30 - 14:1545 mins
              Global eSubmissions
              Examine the Intersection Between eCTD and IDMP
              • Andreas Franken - Head of Clinical Research and eSubmission, Data Protection Officer, Bundesverband der Arzneimittel-Hersteller e.V. BAH
              BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 14:15 - 15:0045 mins
              Regulatory Information Management
              The Future of Documents: Structured Content, Integrated Data
              • Jan Benedictus - CEO, Fonto
              BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 14:15 - 15:0045 mins
              Global eSubmissions
              Recent Developments in eCTD 4.0
                BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 15:00 - 15:3030 mins
                Networking Break
                  BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 15:30 - 16:1545 mins
                  Regulatory Information Management
                  Exposing the Value of Regulatory Information Management Beyond Data and Documents
                  • Laurent Lefebvre - RA CMC Director, RIM System Delivery Lead, Novartis
                  BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 15:30 - 16:1545 mins
                  Global eSubmissions
                  EFPIA Recommendations for eCTD
                  • Anna Sokolowicz - Senior Manager, Submission Production & MSR Coordination, GSK
                  BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 16:15 - 17:0045 mins
                  Regulatory Information Management
                  Building Comprehensive Future-Proof Pharmaceutical Labelling Management
                  • Cham Williams - Associate Director, Business Systems, IQVIA
                  • Julian Backhouse - Associate Director – Regulatory Technology, IQVIA
                  BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 16:15 - 17:0045 mins
                  Global eSubmissions
                  Spotlight Session: Navigate Submissions Standards with Expert Guidance
                    BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 17:00 - 17:4545 mins
                    Regulatory Information Management
                    Plenary: The Evolution of UK Medicines in the National and Global Context: An ABPI Perspective
                    • Steve Hoare - Quality, Regulatory Science & Safety Policy Director, The Association of the British Pharmaceutical Industry (ABPI)
                    BERLIN SUMMIT: DAY 2 - Thur, 7 Apr 17:00 - 17:4545 mins
                    Global eSubmissions
                    Plenary: The Evolution of UK Medicines in the National and Global Context: An ABPI Perspective
                    • Steve Hoare - Quality, Regulatory Science & Safety Policy Director, The Association of the British Pharmaceutical Industry (ABPI)
                    BERLIN SUMMIT: DAY 1 - Wed, 6 Apr
                    NextBERLIN SUMMIT: DAY 3 - Fri, 8 Apr
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