PharmaFORUM Webcast Biologics "Biosimilar Development" - 29. April 2020

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Preclinical development: From bench to first in human - Regulations, data and study programs, transition to Phase I, small molecules and bi…

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Die Themen - Regulatory framework for the preclinical stage - Drug discovery and formulation development - Pharmacology, pharmacokinetics a…

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Biopharmaceuticals - Development, manufacturing and analytics of monoclonal antibodies and other proteins

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Die Themen Development & manufacturing on 24 June 2024: - Manufacturing process - Formulation - Process changes - Regulatotory requirements…

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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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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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PharmaFORUM Webcast Biologics 2024

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Die Themen - Statistical aspects in the validation of bioanalytical methods - Quality requirements for biologics in clinical studies: Clini…

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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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Seminar: Energy and lightness - with joy through the day

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Do you sometimes feel that everyday life slows you down? We present you with key strategies on how to use stress to your advantage while al…

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Service Portal Advanced [SNSPA-OD]

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OVERVIEW Get a Service Portal and Widget Development deep-dive with Service Portal Advanced. OBJECTIVES This course takes attendees on a Se…

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Migrating to AWS [GK4532]

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OVERVIEW This 3-day AWS migration course is for individuals who seek an understanding of how to plan and migrate existing workloads to the …

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Agile Engineering

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When you have learned the basics of agile software development, you might wonder how to actually get things done and get your software out …