Agenda eRA 2017

draft version - subject to change

Day 2 - 11 May


A4 Next Generation Document and Submission Management

09:00 A Closer Look: The Implementation & Integration Process of a Publishing Tool with an EDMS - Joann Tien, ACADIA Pharmaceuticals

09:30 Mission submission - new frontiers & lessons learned when providing submissions to other departments - Ulrich Plener, Merck KGaA Germany

10:00 RIM - A single system or a happy family - James Kelleher, Generis

B4 Technology and Innovations in Business Processes

09:00 The future of Pharma is digital – Are you ready? - Michael Menges, Werum, Klavs Esbjerg, Epista Life Science and Anjana Pindoria, EXTEDO

09:30 Find the data you need for IDMP: Innovative methodology to identify, extract and classify IDMP data - Rasmus Torp Kristensen, Epista Life Science

10:00 Engage Business for Innovation - Technology enabled - Ruedi Blattmann, Life Sciences Consulting Partners (LSCP)


A5 EXTEDO Outlook

10:30 EXTEDO 4.0 – what’s coming next? - Martin Schmid and Maximilian Munte, EXTEDO


11:00 Coffee break


Experts Meetings

The experts meetings (user group meetings) are limited to customers of the respective product. D6/D7 is open for Regulatory Authorities only.

Non-customers are invited to visit our demo stations or the E6/E7 sessions during that time.

A6 eCTDmanager Experts Meeting

11:30 Modules & Services Roadmap - Gunther Treiber, EXTEDO

  • Introduction
  • Regulatory Roadmap
  • Submission Product Roadmaps eCTDmanager and EURSvalidator
  • eCTDmanager - Features and related RCC Services
  • News from Customer Care
  • Client Presentation 

B6 PcVmanager Experts Meeting

11:30 Experts Meeting Part 1 - Dr. Andrea Striebel and Benjamin Beier, EXTEDO

  • Introduction
  • Regulatory roadmap
  • PcVmanager release 2.4 SP1 – what´s new
  • PcVmanager for clinical trials

C6 MPDmanager & RImanager Experts Meeting

11:30 Experts Meeting Part 1 - Anjana Pindoria, EXTEDO

  • Interactive session to share feedback/opinions from the eRA sessions.
  • How the EU Business Drivers for IDMP could impact the industry.
  • Today's business efficiencies and how to manage the future demands.

D6 EURS Experts Meeting

11:30 Experts Meeting Part 1 - Michael Gessert, EXTEDO

  • EXTEDO for NCAs - Christine Hirt, EXTEDO

    • EURSvalidator & Regulatory Roadmap
    • Services for NCAs
    • IDMP at NCAs

  • EURSnext - Andreas Wastl, EXTEDO

    • Demo
    • Roadmap
    • EURSclassic to EURSnext transmission
    • What are you looking for?

E6 CIS Region: Key directions in national regulatory affairs and pharmacovigilance trends (in Russian language)

11:30 Presentations by Health Authorities from the CIS region (Russian Federation, Kazakhstan, Ukraine, Moldova, Georgia, Belarus, Armenia, Uzbekistan, Azerbaijan)


13:00 Lunch break


A7 eCTDmanager & eSUBmanager Experts Meeting

14:00 New Features, Q&A - Gunther Treiber and Andreas Wastl, EXTEDO

  • News from Regulatory Solution Training
  • Submission Product Roadmap eSUBmanager
  • eCTDmanager and eSUBmanager Synergies
  • Open Discussion – Customer Topics
  • Q&A
  • Closing Remarks

B7 PcVmanager Experts Meeting

14:00 Experts Meeting Part 2 - Dr. Andrea Striebel and Benjamin Beier, EXTEDO

  • Fusion of eCTD and IDMP – Benefits for you! Anjana Pindoria, EXTEDO
  • Open discussion – customer topics
  • Q & A
  • News from Customer Care - Keith Wallace, EXTEDO
  • Closing remarks

 

 

C7 MPDmanager & RImanager Experts Meeting

14:00 Experts Meeting Part 2 - Alexander Beck, EXTEDO

  • EXTEDO solutions to manage the shift towards a big data world

    • RImanager and MPDmanager
    • Use cases for Managing IDMP

  • EXTEDO Offering

    • Product Roadmap
    • Service offering

  • CV management

    • The impact for Industry

  • Data Migration between XEVMPD to IDMP

D7 EURS Experts Meeting

14:00 Experts Meeting Part 2 - Michael Gessert, EXTEDO

  • News from Customer Care - Keith Wallace, EXTEDO
  • User Success Story:
    The Swissmedic Solution to Fully Electronic Communication - Heinz Knöpfli, Swissmedic
  • Fusion of eCTD and IDMP – Benefits for you! Anjana Pindoria, EXTEDO

E7 CIS Region: Key directions in national regulatory affairs and pharmacovigilance trends (in Russian language)

14:00 Presentations by Health Authorities from the CIS region (Russian Federation, Kazakhstan, Ukraine, Moldova, Georgia, Belarus, Armenia, Uzbekistan, Azerbaijan)


15:30 Coffee and end of conference


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