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36: What’s happening with eCTD 4.0: New and future developments

36: What’s happening with eCTD 4.0: New and future developments

Update: 2025-07-18

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Join Karl-Heinz Loebel, Director, Regulatory Informatics & Operations at PharmaLex, as he discusses current progress of eCTD 4.0. Ten years after the eCTD 4.0 standard became available for submissions to any ICH-participating regulatory agency, there is movement in some regions towards implementation. Karl-Heinz shares his knowledge and perspective on the journey so far and the outlook for further eCTD 4.0 adoption.

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In Channel

37: Optimizing revenue from mature products

37: Optimizing revenue from mature products

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36: What’s happening with eCTD 4.0: New and future developments

36: What’s happening with eCTD 4.0: New and future developments

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32: Commercialization Readiness

32: Commercialization Readiness

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31: Key Steps for Site Inspection Readiness

31: Key Steps for Site Inspection Readiness

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30: CSS Overview

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29: Exploring the interactions between validation and technology transfer

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27: Assessing gaps and achieving compliance with Annex 1

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26: Navigating the Process of Technology Transfer

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25: Scaling Patient Safety through Innovation

25: Scaling Patient Safety through Innovation

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24: Why Early Phase Modeling is Key to Reimbursement and Patient Access

24: Why Early Phase Modeling is Key to Reimbursement and Patient Access

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23: The Unique and Complex World of Combination Products

23: The Unique and Complex World of Combination Products

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22: Avoiding Pitfalls with your Product Development Strategy

22: Avoiding Pitfalls with your Product Development Strategy

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21: Navigating a complex global regulatory environment to bring medicinal products to market

21: Navigating a complex global regulatory environment to bring medicinal products to market

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20: Safety Reporting Requirements for Marketing in the EU

20: Safety Reporting Requirements for Marketing in the EU

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19: The important role of AI in TMF oversight

19: The important role of AI in TMF oversight

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18: Tackling performance requirements in the more prescriptive world of IVDR

18: Tackling performance requirements in the more prescriptive world of IVDR

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36: What’s happening with eCTD 4.0: New and future developments

36: What’s happening with eCTD 4.0: New and future developments

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