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32: Commercialization Readiness

32: Commercialization Readiness

Update: 2024-11-04

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Pharmaceutical companies new to the EU market must navigate complex and varying commercialization requirements. The podcast highlights key steps for commercialization readiness in Europe, focusing on the challenges non-EU companies face, including supply chain logistics and regulatory complexities. Early planning, strategic partnerships, and understanding local regulations are essential for successful product launches in diverse European markets.

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In Channel

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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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35: Challenges and best practices for managing local pharmacovigilance activities

35: Challenges and best practices for managing local pharmacovigilance activities

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34: Environmental Risk Assessment and its growing importance in the German Pharma Strategy

34: Environmental Risk Assessment and its growing importance in the German Pharma Strategy

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33: Finding the best approach to manage sterility assurance

33: Finding the best approach to manage sterility assurance

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32: Commercialization Readiness

32: Commercialization Readiness

2024-11-0413:10

31: Key Steps for Site Inspection Readiness

31: Key Steps for Site Inspection Readiness

2024-06-2717:45

30: CSS Overview

30: CSS Overview

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29: Exploring the interactions between validation and technology transfer

29: Exploring the interactions between validation and technology transfer

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28: Early access programs: What they are and how to plan for them

28: Early access programs: What they are and how to plan for them

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27: Assessing gaps and achieving compliance with Annex 1

27: Assessing gaps and achieving compliance with Annex 1

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26: Navigating the Process of Technology Transfer

26: Navigating the Process of Technology Transfer

2023-11-1418:29

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

2023-09-1211:46

23: The Unique and Complex World of Combination Products

23: The Unique and Complex World of Combination Products

2023-08-3110:28

22: Avoiding Pitfalls with your Product Development Strategy

22: Avoiding Pitfalls with your Product Development Strategy

2023-08-0212:40

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

2023-07-1813:53

20: Safety Reporting Requirements for Marketing in the EU

20: Safety Reporting Requirements for Marketing in the EU

2023-07-0620:11

19: The important role of AI in TMF oversight

19: The important role of AI in TMF oversight

2023-05-2412:06

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

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

2023-04-0513:22

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32: Commercialization Readiness

32: Commercialization Readiness

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