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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
  • Cecile Riboud - Senior Director Europe Integrated Global Compliance, IQVIA
09:55 - 10:005 mins
Global eSubmissions
Opening Remarks from Chair
  • Cecile Riboud - Senior Director Europe Integrated Global Compliance, IQVIA
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
    • Veronica Lipucci Di Paola - PMS Business Lead and Master Data Manager, EMA
    • Isabel Chicharo - Head of Regulatory Data Management Service at EMA, EMA
    • Patrick Middag - Information Technology Business Partner Regulatory IDMP Associate Director, Bristol-Myers Squibb, Belgium
    10:00 - 10:4040 mins
    Global eSubmissions
    Interview with Members of IDMP Taskforce
    • Laurent Desqueper - XEVMPD & IDMP Business System Owner, MSD Europe Inc, Germany
    • Veronica Lipucci Di Paola - PMS Business Lead and Master Data Manager, EMA
    • Isabel Chicharo - Head of Regulatory Data Management Service at EMA, EMA
    • Patrick Middag - Information Technology Business Partner Regulatory IDMP Associate Director, Bristol-Myers Squibb, Belgium
    10:00 - 10:4040 mins
    Regulatory Affairs in Latin America
    LATAM – Access to Innovation, Harmonization, Convergence, Reliance
    • Lawrence Liberti - Adjunct Assistant Professor, Temple University School of Pharmacy
    • Mario Alanis - Senior Consultant, Centre for Innovation in Regulatory Science (CIRS)
    • Ana Padua - Associate Director - Global Regulatory Affairs CMC Regulatory Intelligence, Merck Group
    • Silvia Bendiner - Executive Partner, WESSX
    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
    IDMP More than a Requirement: Business Benefits.
    • Quentin Grignet - Director – Master Data Strategy & Analytics, IDMP Program Sponsor, GSK, Belgium
    10:45 - 11:3550 mins
    Regulatory Affairs in Latin America
    Brazil: Key Regulatory Strategies
    • Arturo Gonzalez-Martinez - Senior Regulatory Expert Japan and LATAM, GSK, Belgium
    • Pedro Franco - Director Europe for Global Regulatory & Scientific Policy (GRASP), Merck Group
    • Priscila Rodrigues - Regulatory Affairs Director, Merck Group
    • Ana Padua - Associate Director - Global Regulatory Affairs CMC Regulatory Intelligence, Merck Group
    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
    • Paul Attridge - Sr Director Strategy, Veeva Systems, UK
    11:15 - 11:4025 mins
    Global eSubmissions
    Responding to a Pandemic, the Regulatory Operations Experience
    • Jack Daley - Manager, Regulatory Operations, Gilead Sciences, UK
    11:40 - 12:0525 mins
    Regulatory Affairs in Latin America
    Brazil: Regulatory Framework - APIs
    • Erika Diago Rufino - Senior Manager Regulatory Affairs, Janssen
    11:45 - 12:1025 mins
    Global eSubmissions
    eCTD 4.0 – A Global Overview
    • Frank Dickert - Senior Business Consultant, EXTEDO
    11:50 - 12:1525 mins
    IDMP Focus Day
    Developing an IDMP Change Management Programme
    • Karen Harry - Director, Regulatory Implementation, Calyx
    12:15 - 12:3520 mins
    IDMP Platform Solutions
      12:35 - 13:1540 mins
      Networking Break
        13:15 - 13:4025 mins
        IDMP Focus Day
        IDMP, where to start”
        • Ramón Hernández Moratinos - Senior Regulatory Information Specialist, Asphalion
        13:15 - 13:4025 mins
        Global eSubmissions
        Brexit – Q1 2021 Experience – An EFPIA View
        • Alastair Nixon - Director, Submission Standards, Global Regulatory Platform and Delivery, GlaxoSmithKline Research & Development Limited, UK
        13:15 - 13:4025 mins
        Regulatory Affairs in Latin America
        Brazil: Rare Diseases - Strategic Regulatory Pathway
        • Telma Rocha - Senior Regulatory Affairs Manager, Janssen
        13:45 - 14:1025 mins
        IDMP Focus Day
        Sharing Experiences with Integrating Different Systems for IDMP
        • Laurent Lefebvre - Regulatory CMC Associate Director - RA, Novartis Pharma AG
        13:45 - 14:1025 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.
        13:45 - 14:1025 mins
        Regulatory Affairs in Latin America
        Colombia: Regulatory Overview and Drug Registration
        • Johanna Garcia - Consultant, Udelá
        14:15 - 14:3520 mins
        IDMP Focus Day
        Implementing IDMP on a Time Crunch
        • Costas Mistrellides - IDMP Regulatory Affairs Co-Ordinator, Merck Group
        14:15 - 14:4025 mins
        Global eSubmissions
        IDMP/ eCTD Interactive Surgery
        • Joel Finkle - Associate Director, Regulatory Information Management, BeiGene, Ltd
        14:15 - 14:4025 mins
        Regulatory Affairs in Latin America
        Mexico: Overview of the Regulatory landscape
        • Rivelino Flores - Director of Regulatory Affairs and Innovation, Canifarma
        14:40 - 15:0020 mins
        IDMP Focus Day
        IDMP uses/strategies representing
        • Remco Munnik - Regulatory Information Director, Medicines for Europe
        15:00 - 15:5050 mins
        Networking Break including Phlexglobal's Roundtable and COFEPRIS 2021: Opportunities, Challenges & Perspectives Roundtable
          15:50 - 16:1525 mins
          IDMP Focus Day
          IDMP Roadmap to Success
          • Agnes Cwienczek - Head of Product Management and Consulting, AMPLEXOR Life Sciences
          • David Gywn - Vice President, AMPLEXOR Life Sciences
          15:50 - 16:1525 mins
          Global eSubmissions
          The SPOR Target Operating Model (TOM) – Understanding the impact on your Submissions and Processes”
          • Kelly Hnat - Principal, K2 Consulting, USA
          15:50 - 16:1525 mins
          Regulatory Affairs in Latin America
          Pharmacovigilance and Risk Management in LATAM
          • Josue Bautista Arteaga - President, The Mexican Drug Safety Society
          16:20 - 16:4525 mins
          IDMP Focus Day
          Practical Advice on Being Prepared to Migrate from EVMPD to IDMP
          • Mandy Mason - Associate Director, Data Stewardship & Compliance, BMS
          16:20 - 16:4525 mins
          Global eSubmissions
          Automation for Submissions
          • Dr Katharina Schmitz - Head of Automator Solutions, LORENZ Life Sciences Group
          16:20 - 17:0040 mins
          Regulatory Affairs in Latin America
          How has COVID-19 Affected the LATAM Region and the Regulatory Landscape?
          • Lawrence Liberti - Adjunct Assistant Professor, Temple University School of Pharmacy
          • Mario Alanis - Senior Consultant, Centre for Innovation in Regulatory Science (CIRS)
          • Maria de la Luz Lara Méndez - CEO, Udelá
          • Silvia Bendiner - Executive Partner, WESSX
          16:50 - 17:1525 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
          DAY ONE
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