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DAY TWO - CET (Central European Time, GMT+1)

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DAY TWO - CET (Central European Time, GMT+1)

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09:55 - 10:005 mins
IDMP Focus Day
Opening Remarks from Chair
    09:55 - 10:005 mins
    Global eSubmissions
    Opening Remarks from Chair
      09:55 - 10:005 mins
      Regulatory Affairs in Latin America
      Opening Remarks from Chair
        10:00 - 10:4040 mins
        IDMP Focus Day
        Interview with Members of IDMP Taskforce
        • Laurent Desqueper - XEVMPD & IDMP Business System Owner, MSD Europe Inc, Germany
        • Ana López De La Rica Manjavacas - International and EU Affairs Division, AEMPS, Spain
        10:00 - 10:4040 mins
        Global eSubmissions
        Interview with Members of IDMP Taskforce
        • Laurent Desqueper - XEVMPD & IDMP Business System Owner, MSD Europe Inc, Germany
        • Ana López De La Rica Manjavacas - International and EU Affairs Division, AEMPS, Spain
        10:00 - 10:4040 mins
        Regulatory Affairs in Latin America
        LATAM – Access to Innovation, Harmonization, Convergence, Reliance
        • Belkis Romeu - Manager Office of Innovation, Cuban Regulatory Authority – CECMED
        • Lawrence Liberty - Director, Centre International Regulatory Sciences (CIRS)
        • Mario Alanis - Senior Consultant, Centre International Regulatory Sciences (CIRS)
        10:45 - 11:1025 mins
        IDMP Focus Day
        IDMP More than a Requirement: Business Benefits.
        • Quentin Grignet - Director – Master Data Strategy & Analytics, IDMP Program Sponsor, GSK, Belgium
        10:45 - 11:1025 mins
        Global eSubmissions
        Status, Timelines and Requirements of eCTD 4.0
          10:45 - 11:1025 mins
          Regulatory Affairs in Latin America
          Brazil: Best Regulatory Strategies, Market Access and Reimbursement
          • Arturo Gonzalez-Martinez - Senior Regulatory Expert Japan and LATAM, GSK, Belgium
          11:15 - 11:4530 mins
          IDMP Focus Day
          Interactive Session: Preparing for IDMP Implementation
          • Margo Tyler-Mcwilliams - Associate Director, Regulatory Informatics and Analytics Global Regulatory Operations, Takeda
          • Patrick Middag - Information Technology Business Partner Regulatory IDMP Associate Director, Bristol-Myers Squibb, Belgium
          • Laurent Lefebvre - Regulatory CMC Associate Director - RA, Novartis Pharma AG
          11:15 - 11:4530 mins
          Global eSubmissions
          eCTD V4: Industry Experience in Swiss and EU
          • Shakul Hameed - Associate Director - Lead - Regulatory Information Management & Technologies, Takeda
          11:15 - 11:4530 mins
          Regulatory Affairs in Latin America
          Brazil: Regulatory Framework - APIs
          • Ronaldo Lucio - General Manager of Inspections, ANVISA
          11:50 - 12:1525 mins
          IDMP Focus Day
          Session from Calyx
          • Karen Harry - Director, Regulatory Implementation, Calyx
          11:50 - 12:1525 mins
          Global eSubmissions
          eCTD 4.0 with EXTEDO
          • Frank Dickert - Senior Business Consultant, EXTEDO
          11:50 - 12:1525 mins
          Regulatory Affairs in Latin America
          Examining Brazil’s Harmonization Efforts
          • Antonio Barra Torres - President, ANVISA
          12:15 - 13:1560 mins
          Networking Break including IDMP Platform Solutions
            13:15 - 13:4025 mins
            IDMP Focus Day
            Spotlight Session
              13:15 - 13:4025 mins
              Global eSubmissions
              Understanding how Submission of More Product Data as Structured Data could Impact the eCTD Dossier Process’.
              • Andreas Franken - Data Officer, B.A.H.
              13:15 - 13:4025 mins
              Regulatory Affairs in Latin America
              Brazil: Orphan Drug Registration - Strategic Regulatory Pathway
              • Solange Nappo - Regulatory Affairs Director, Interfarma
              13:45 - 14:1025 mins
              IDMP Focus Day
              Sharing Experiences with Integrating Different Systems for IDMP
              • Stephen Blanchard - IDMP Programme Lead, Johnson & Johnson Consumer EAME, UK
              13:45 - 14:1025 mins
              Global eSubmissions
              Data vs Documents: Regulatory Affairs Impact
              • Alastair Nixon - Director, Submission Standards, Global Regulatory Platform and Delivery, GlaxoSmithKline Research & Development Limited, UK
              13:45 - 14:1025 mins
              Regulatory Affairs in Latin America
              Mexico: Overview- Regulatory landscape & Market Access
              • Julio Sánchez y Tépoz - President, ALo Prosciences / Former Federal Commissioner - COFEPRIS
              14:15 - 14:5540 mins
              IDMP Focus Day
              Implementing IDMP on a Time Crunch
              • Costas Mistrellides - IDMP Regulatory Affairs Co-Ordinator, Merck Group
              14:15 - 14:5540 mins
              Global eSubmissions
              IDMP/ eCTD Interactive Surgery
              • Joel Finkle - Associate Director, Regulatory Information Management, BeiGene, Ltd
              14:15 - 14:5540 mins
              Regulatory Affairs in Latin America
              Colombia: Regulatory Overview and Drug Registration
                14:55 - 15:5560 mins
                Networking Break including Roundtables
                  15:55 - 16:2025 mins
                  IDMP Focus Day
                  Practical Advice on Being Prepared to Migrate from EVMPD to IDMP
                  • Mandy Mason - Associate Director, Data Stewardship & Compliance, BMS
                  15:55 - 16:2025 mins
                  Global eSubmissions
                  Responding to a Pandemic, the Regulatory Operations Experience
                  • Jack Daley - Manager, Regulatory Operations, Gilead Sciences, UK
                  15:55 - 16:2025 mins
                  Regulatory Affairs in Latin America
                  Pharmacovigilance and Risk Management in LATAM
                    16:25 - 16:5025 mins
                    IDMP Focus Day
                    Ensuring data compliance for ‘Legacy’ Products under IDMP and other telematic programmes
                    • Argha Nag - Global Regulatory Systems & Data Governance Lead, AstraZeneca
                    16:25 - 16:5025 mins
                    Global eSubmissions
                    Automation for Submissions
                    • Dr Katharina Schmitz - Head of Automator Solutions, LORENZ Life Sciences Group
                    16:25 - 16:5025 mins
                    Regulatory Affairs in Latin America
                    How has COVID-19 Affected the LATAM Region and the Regulatory Landscape?
                    • Julio Sánchez y Tépoz - President, ALo Prosciences / Former Federal Commissioner - COFEPRIS
                    • Belkis Romeu - Manager Office of Innovation, Cuban Regulatory Authority – CECMED
                    • Lawrence Liberty - Director, Centre International Regulatory Sciences (CIRS)
                    • Mario Alanis - Senior Consultant, Centre International Regulatory Sciences (CIRS)
                    16:50 - 16:555 mins
                    END OF CONFERENCE DAY 2
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