Global eCTD/Electronic Dossier & eSubmission - The EU, the US, LATAM, Asia, MENA, Africa and the RoW in focus

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eCTD Essentials - Intensivseminar für das Regulatory Operations Team

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Die Themen - Vergleich länderspezifische und ICH-Richtlinien für eCTD (electronic Common Technical Document) - Aktueller Stand und Entwickl…

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CMC Management in Regulatory Affairs - Quality data for marketing authorisation in Europe

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Die Themen - Regulatory requirements in the EU and the ICH region - Essential quality data for marketing authorisation - CMC documentation:…

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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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PharmaFORUM Webcast International - "Marketing Authorization in the USA" 5 November 2024

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Die Themen Ziele Do you work in international regulatory affairs? We would like to invite you to join our live webcasts, where local regula…

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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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Pharmacovigilance Requirements in China - LATAM - EAEU - MENA - 5 webcasts in two days: Legal framework, Country-specific requirements and …

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Die Themen - Legal framework in selected (emerging) countries or regions - Similarities and differences in ADR collection and reporting com…

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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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ISO in the Sun: ISO Annex SL IMS Lead Auditor in Lanzarote

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*** Dieser Kurs kann auf Anfrage auch auf Deutsch gehalten werden ***SummaryThis five day course introduces the structure of an IMS derived…

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GxP-Regulated Archiving

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Die Themen - Compliance requirements within the GMP, GLP, and GCP framework in the pharmaceutical sector - Audit security, electronic archi…

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ISO in the Sun: Integrated Management System (IMS) Lead Auditor

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This five-day course provides an overview to the structure of an Integrated Management System (IMS) based on ISO Annex SL, and how to audit…