Contact Person
    Nicole Mastrell

    Event Manager & PA to CEO
    Email: nm@mva.org
    Phone: (M) +45 6141 8634 Linkedin

    Industry event: Global PV operations and oversight

    Challenges maintaining a globally compliant approach across local requirements

    Date: 2. May 2018
    Time: 12:00 – 16:30
    Venue: Rådhuspladsen 4, Rådhuspladsen 4, 1550 København V, Denmark

    The event is free to attend.

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    About The Event

    Managing pharmacovigilance (PV) across the globe is an increasingly difficult task. The role of the QPPV and associated oversight responsibilities are today multi-faceted, demanding global-local understanding and fast flow of information across HQ, affiliates and CROs/partners.

    The drive for building localized legislative frameworks for PV also represent a significant workload on regulatory intelligence and legal staff of pharma companies. How are these challenges best managed? How should the division of responsibilities across global-local entities look like optimally? And where could automation be most useful?

    Learn more about impact of regulations, processes and technologies to support your business. Meet colleagues from industry, understand challenges and get ideas for actions to take.

    The intended target audiences are PV leaders, QPPV’s, QPPV-office / Regulatory Intelligence staff, PV technology staff, Legal representatives, local operating PV represenatives and CROs

    Agenda:

    11:45

    Networking lunch

    12:30

    Challenges maintaining compliant PV operations in a world of changing regulations

    Welcome/event introduction

    Macro-trends in the global environment and current and upcoming impacts for pharma

    by Martin Holm-Petersen , CEO, Insife

    12:50

    Navigating global markets from a legal viewpoint

    Considerations for pharma companies on global litigation risks

    General Data Protection Regulation (GDPR) update

    by DLA Piper

    13:20

    Novo Nordisk’s QPPV office

    Thoughts on current challenges and priorities for the future at the Novo Nordisk QPPV office

    by Pilar Carrero , VP, Novo Nordisk

    14:05 Break
    14:20

    Safety database and beyond – evolving to continuously meet global regulatory compliance

    What are the learnings from the EudraVigilance rollout since November, and what can we expect with R3 in Japan from April 2019?

    Configuring the safety database for GDPR compliance / good practices for site security etc.

    What key changes have been introduced in the past releases of the Argus safety suite and which changes are expected in the near future?

    What are the options when automating global PV? E.g. Translations, Patient support programs, market research programs, literature monitoring. social media scanning etc?

    by Michael Braun-Boghos , Director, Oracle

    15:20 Discussing and sharing challenges and priorities
    16:00

    Orchestrating processes between local and global organizational entities

    Examples of where processes typically become sub-optimal due to lack of efficient technology, across stakeholders in the global business

    Finding ways to replace spreadsheets and secure an effective end-to-end process

    Options for automation inline in the process

    by Peter Stroyer Pallesen , Director, Insife

    16:30  Meeting end

     

    This event is held by Insife, Oracle Health Sciences and DLA Piper: