Virtual Regulatory Agency Innovation Day

Due to the unprecedented situation, we have decided to replace our Innovation Days by virtual meetings. So we invite you to join EXTEDO's first Virtual Regulatory Agency Innovation Day, which will take place on 07 May 2020 as an 2-hour online meeting.

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 agencies 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 Business Processes
  • Interactive Session – Ask Questions to the Panelists

Event Details

  • Date: Thursday, 07 May 2020
  • Start time:
    • 09:00h BST (London, Lisbon)
    • 10:00h CEST (Berlin, Rome)
    • 12:00h GST (Dubai, Muscat)
    • 16:00h CST (Shanghai)
  • Duration: 2 hours
  • Participation is free of charge
  • This event is open for delegates from Regulatory Authorities only

Registration

https://attendee.gotowebinar.com/register/7712822686344962828

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