TRAINING | eSubmission Manager in Europe

eSubmission and database requirements in 2020

The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD.

He will speak about the following subjects:

eSubmission – Regulatory update

  • XEVMPD, IDMP, SPOR: Efficient data maintenance and integrity
  • Regulatory information management
  • eSubmission and the various purely national requirements in Europe
  • IT know-how for eSubmission managers

eSubmission – Regulatory Update

  • The EU Telematics Strategy (2020-2025)
  • Submission of electronic dossiers
  • Submission portals: CESP, CESSP and EMA eSubmission Gateway
  • Creation of delivery files and eAF
  • Optimising submission management
  • Electronic product information

eSubmission and the various purely national requirements in Europe – How to master this balancing act

XEVMPD – Efficient data maintenance

  • XEVMPD, how much longer?
  • The transition to IDMP/SPOR

IDMP & SPOR

  • EMA Master Data Mgmt. Roadmap
  • The upcoming IDMP draft implementation guide
  • SPOR concept
  • What data has to be collected?

Implementation of IDMP – Hands-on tips

  • Preparation of the required data
  • GAP analysis and strategies for IDMP implementation in the enterprise
  • Smart IDMP: What benefits does IDMP bring to my company?

Hands-on eCTD: Frequent dossier preparation problems and possible validation problems

  • Case studies for discussion and experiences with the EU Module 1 specifications
  • eCTD 4.0 (next major version)
  • Existing dossiers: Conversion to eCTD in the life cycle

 

More information and subscribe

Date

18 May 2020 - 19 May 2020
Expired!

Location

Amsterdam
The FORUM Institut für Management

Organizer

The FORUM Institut für Management
Website
http://www.forum-insitut.com

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