PharmaFORUM Webcast Biologics "Establishing a starting dose for a first-in-human clinical trial: A challenge for gene/cell therapies" - 6 July 2021

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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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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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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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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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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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Mastering ICH Quality Guidelines: From Development to Lifecycle Management - Quality by Design and strategies for a successful ICH Q12 impl…

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Die Themen - From QbD (ICH Q8) to designed lifecycle management (ICH Q12): How to make the most of ICH Q12 opportunities - Special consider…

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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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Advanced Skills for Senior Office Professionals

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2x3hr virtual expert-led sessions Over 2 consecutive days 1:1 Virtual coaching session On-demand digital learning playlist Overview This wo…