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international training

eCTD & IDMP: Challenges in Electronic Submissions

  • 23/05/2018 - 25/05/2018
  • Frankfurt, Germany

Your prominent trainers

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KEY TOPICS

eCTD in practice

Key eCTD features

Documents, Folder Structure, XML-backbone

eCTD acceptance: Countries and Regions

The European eSubmission Roadmap

Nationally authorized products

From XEVMPD to SPOR, IDMP and beyond

SPOR – IDMP implementation strategies

IDMP Data Preparation, Maintenance Management & RIM

Exercises, demonstrations and hands on opportunities throughout the course

key takeaways

Understand

  • The European eSubmission Roadmap and Mandatory Switch to eCTD. What is really relevant?

  • SPOR – IDMP implementation in Europe: timeline, iterations & phases

Learn

  • How to use CESP, EMA Gateway, and US/CA eSubmission Gateway
  • How to compile, hyperlink, publish and validate your eCTD Submissions

Gain

  • IDMP solutions as a basis for RIM
  • SPOR in detail – initial content, content validation & maintenance

training features

Hands-on workshop, practical exercises, software demonstration

Individual case by case consultancy with the trainers

Comprehensive printed and digital course documentation

8h+ of Networking with other industry experts

Case studies from the trainer's experience

Certificate of Completion issued by the trainers

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Delegate Fee

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JOIN US IN FRANKFURT

Frankfurt is a centre for commerce, culture, education, tourism and web traffic. Messe Frankfurt is one of the world's largest trade fairs at 578,000 square metres and ten exhibition halls, a central logistics centre and an attached convention centre.

PARTNERS AND SPONSORS

This event is supported by the following companies.

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