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FORUM Institut für Management GmbH: 83 Produkte

WIR BILDEN WEITER - 40 Jahre FORUM Institut. Wir unterstützen seit 40 Jahren Fach- und Führungskräfte nahezu aller Unternehmensbereiche, indem wir wichtige Trends und notwendiges Fachwissen erkennen, aufbereiten und in angenehmer Atmosphäre vermitteln. Unterschiedliche Projektbereiche konzipieren Konferenzen, Seminare, Lehrgänge, Workshops und e-Learnings für viele industrielle Branchen und Wirt…

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Toxicology and beyond: Safety assessment in drug development - Know-how for employees in R&D, Medical affairs, Regulatory affairs & Pharmac…

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Die Themen - Pharmacokinetics and toxicokinetics - Safety pharmacology and photosafety evaluation - Genotoxicity, carcinogenicity, reproduc…

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CMC Writing - The essentials - with practical examples and exercises

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Die Themen - Structure and presentation of Module 3 and Module 2 - CTD sections in detail: S-Part, P-Part, specific sections - Country spec…

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Medical Writing in Pharmacovigilance - Update your PV writing skills with numerous exercises!

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Die Themen - PV documents throughout the life cycle of a medicinal product: DSUR, RMP, and PSUR - Best practices, common pitfalls, and cult…

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Prior Use before The UPC, The EPO, German, Chinese And U.S. Courts

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Die Themen - Prior use before the Unified Patent Court - Prior use before the European Patent Office - Prior use before the German Federal …

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Medical Devices for Beginners - Compact seminar on the entire medical device development process in compliance with the MDR

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Die Themen - Introduction to medical devices and regulatory fundamentals - Classification and conformity assessment procedures - Clinical e…

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G2/21 - Plausibility and Now?

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Die Themen - G2/21: guidance on when a technical effect demonstrated by post-filed data can be taken into account - Structured toolbox for …

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MSLs in Transition: Navigating Change in Europe

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Die Themen - EU Regulatory Changes: AI Act, HTA, Pharmaceutical Package, and EHDS - key updates for MSL practice - Emerging Therapies and H…

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Bank Accounting - Deep Dive HGB (German Commercial Code), special features IFRS, CSRD, VSME

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Die Themen - Practical knowledge of current HGB: Deep dive - Current principles, knowledge and developments HGB - Special features and acco…

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Global Regulatory Affairs Essentials - Key Strategic and Operational Aspects

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Die Themen - Strategic Planning - Global Regulatory Collaboration - Health Technology Assessment (HTA) Integration - Global Regulatory Doss…

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Patient Involvement in HTA

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Die Themen - Evolving Role of Patient Advocates in EU HTA - Patient Engagement with NICE: Lessons from the UK - The Role of Patients in Ger…

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How to Protect And Manage Trade Secret Assets

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Die Themen - Evolving developments shaping the trade secret landscape - Disputes and enforcement - Why trade secret metadata matters - Less…

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Quality Management and Process Optimization in Medical Affairs - Structuring business processes, ensuring quality documentation and complia…

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Die Themen - Compliance & Business Process Management (BPM) in Medical Affairs - Business Process Management & Quality Documentation in Med…

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IP Agreements: Research and Development Agreements

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Die Themen - Contract research and R&D cooperation - Cooperation with universities - IP transfer I Non disclosure agreements - Choice of la…

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IP Agreements: Patent License Agreements

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Die Themen - Scope of license - License fees - Actions against infringers - Know- how protection - Cross-Licenses - Antitrust law - Patent …

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All about ATMP - Development - Quality - CMC - Authorisation - Market Access

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Die Themen - From blood, tissues & cells to ATMP - GMP and Module 3 requirements for ATMPs - Requirements for clinical and non-clinical dev…