Marketing Authorisation in ASIA - Online seminar: China, Indonesia, Hong Kong, Singapore, Thailand, Korea, Malaysia, The Philippines, Vietnam, Taiwan

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Regulatory Affairs and GMP compliance in Eastern Europe - Considerations for the EAEU and Non-EAEU markets

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Die Themen - EAEU pharmaceutical market: Regulatory Status quo - Registration of new drugs in the EAEU - Variations in the EAEU - CMC docum…

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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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CMC dossier requirements for biologics: FDA vs EU - Marketing Authorisation of large molecues in the US with a focus on CMC

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Die Themen - Regulatory landscape in the US - Scientific advice - The IND and BLA procedure - Post-approval/maintenance: Procedures and doc…

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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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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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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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Marketing Authorisation in Latin America - Online seminar with a focus on: Brazil, Mexico, Argentina, Colombia, Chile, Peru

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Die Themen - LatAm - regulatory environment and harmonisation trends - National procedures in Brazil, Mexico, Argentina, Colombia, Chile, P…

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Blockchain for Healthcare Professionals [BTABKHP]

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OVERVIEW The Blockchain for Healthcare Professionals course reviews how Blockchain is being applied in the Healthcare industry. As the heal…

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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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Finance & Risk in the World of Energy

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The current and future role of energy investment, finance, and risk Transitioning to a carbon-neutral economy will require trillions of inv…