Virtual Classroom Training

Bespoke interactive e-learning

This training course will provide the necessary knowledge about eCTD submissions in Europe.

Date: March 11th, 2021

Type: Virtual Classroom Training

Duration: 0.5-day session

Who should attend?: Regulatory Operations, Regulatory Submissions, Document Authors

All you need to know about submitting eCTD Format application in Europe

The electronic Common Technical Documents (eCTD) is now the mandatory format for most regulatory applications in Europe. Efficient and successful submission preparation in this format requires close alignment and co-operation between document authors, submission managers and the Regulatory Operations team who finally compiles and submits the eCTD. This training course will provide the necessary knowledge about eCTD submissions in Europe for everyone involved in the process, as well as the technical and procedural details for those directly involved in compiling and submitting the applications.

  • eCTD and eSubmission basics, format and design, lifecycle management
  • eCTD generation process and stakeholders
  • submission planning
  • software requirements
  • document authoring for electronic submissions
  • differences for national, MRP/DCP and CP procedures
  • eCTD in EU/EEA, Switzerland and UK
  • submission portals and delivery files
  • validation criteria
  • outlook: eCTD vs. data submission

Karl-Heinz Loebel

Karl-Heinz joined PharmaLex in 2005 as Manager Regulatory Affairs, CMC/Quality and since 2006 he moved through various positions in the area of Regulatory Operations. Currently, he is a Director, Principal Consultant Regulatory Operations Industry/ Agency Liaisons.

He is a much-acclaimed expert in electronic submissions and regulatory information management. Besides his ongoing tasks overseeing and supporting electronic submissions of all categories he also acts as our lead consultant for e-submission and RIMS software implementation and customization projects. His eCTD experiences cover all established eCTD regions as well as recent newcomers like GCC and EAEU countries.

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