Virtual eRegulatory and Pharmacovigilance Innovation Day - Option 2

Due to the unprecedented situation, we have decided to replace our Innovation Days, planned for April/May, by several virtual meetings. So we invite you to join EXTEDO's first Virtual Innovation Day, which will take place on 05 May 2020 as an 2-hour online meeting. This event also takes place on 29 April for different time zones.

Our trusted team will provide an overview of the strategic and telematics initiatives, currently ongoing at an international and European level. We will deep dive into the status, as well as lessons learnt and take-away messages for your own organizations. 

Take a look at how EXTEDO’s latest innovations are supporting the life sciences industry to continue daily business, while facilitating a smooth journey into the future:

  • eCTD 4.0 - Status
  • Target Operating Model (TOM) - What is it?
  • Common European Single Submission Portal (CESSP) - Status
  • New regulations in Pharmacovigilance - Current overview
  • Electronic product information for human medicines in the European Union (ePI)
  • ISO IDMP - Implementation on a global level
  • Substance, product, organisation and referential (SPOR) master data - Status in Europe

Agenda

  • EXTEDO 2020 - Innovation and Beyond
    • Strategic Overview of the Regulatory Landscape
    • Connecting the Dots: eCTD 4.0, TOM, CESSP, PV, ePI, IDMP/SPOR
  • A Walk Through of the Regulated Business Processes
  • Summary and Wrap-up
  • Interactive Session – Ask Questions to the Panelists

Event Details

  • Date: Wednesday, 05 May 2020
  • Start time:
    • 07:30h EDT (New York, Toronto)
    • 12:30h BST (London, Lisbon)
    • 13:30h CEST (Berlin, Rome)
    • 15:30h GST (Dubai, Muscat)
  • Duration: 2 hours
  • Participation is free of charge

Registration

https://attendee.gotowebinar.com/register/8901174853645098508

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