e-Learning: Common Technical Document & eCTD - including CMC requirements for marketing authorisation applications

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e-Learning: Common Technical Document and eCTD - including CMC requirements for marketing authorisation applications

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Die Themen - CTD principles and structure - Format and content of Module 1 - 5 CTD - CMC data required for Module 3 (drug substance and dru…

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e-Learning: CTD Module 3 - Data requirements in the EU

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Die Themen - CTD structure and applicable guidelines - Drug substance Part - ASMF and CEP - Drug product part Ziele Module 3 is an essentia…

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CMC for Biologicals - With a focus on proteins

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Die Themen - Regulatory framework: ICH guidelines - Essential data for biologics for Module 3 - Challenges in Module 3: Focus on antibodies…

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e-Learning: Introduction to EU Marketing Authorisation - Principles, Procedures, Application Types and Maintenance

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Die Themen - Module 1: Overview of the law and EU regulatory network - Module 2: Principles (The European Economic Area & the scope of Dire…

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e-Learning: Stability Testing in the ICH Region - Stability testing for chemical and biological products in the ICH region

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Die Themen - Module 1: Regulatory requirements - Module 2: Factors that influence stability testing - Module 3: Stability test requirements…

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Management of Value MOV Foundation e-learning (including exam)

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Management of Value MOV Foundation e-learning (including exam) Content of the training The main part of the Management of Value MOV Foundat…

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EU Regulatory Affairs Introductory Training Course

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Die Themen - Day 1: Marketing Authorisation procedures in Europe: Legal basis, mutual recognition, decentralised and centralised procedure …

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IBM SS83G - z/OS VSAM and Access Method Services

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Course Outline Introduction to VSAM data sets describe the structure, organization, and use of VSAM clusters explain the function of Contro…

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Microsoft Dynamics 365: Finance and Operations Apps Developer (MB-500) [M-MB500]

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OVERVIEW Developer training. Microsoft Dynamics 365 Finance and Operations Apps Developers implement and extend applications to meet the re…

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Stage I - Controllers Best Practice Online

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Introduction Learn all about the essentials of accounting, reporting and corporate planning, gain an overview of key controlling system com…