FORUM Institut für Management GmbH: 83 Produkte
Toxicology and beyond: Safety assessment in drug development - Know-how for employees in R&D, Medical affairs, Regulatory affairs & Pharmac…
Die Themen - Pharmacokinetics and toxicokinetics - Safety pharmacology and photosafety evaluation - Genotoxicity, carcinogenicity, reproduc…
CMC Writing - The essentials - with practical examples and exercises
Die Themen - Structure and presentation of Module 3 and Module 2 - CTD sections in detail: S-Part, P-Part, specific sections - Country spec…
Medical Writing in Pharmacovigilance - Update your PV writing skills with numerous exercises!
Die Themen - PV documents throughout the life cycle of a medicinal product: DSUR, RMP, and PSUR - Best practices, common pitfalls, and cult…
Prior Use before The UPC, The EPO, German, Chinese And U.S. Courts
Die Themen - Prior use before the Unified Patent Court - Prior use before the European Patent Office - Prior use before the German Federal …
Medical Devices for Beginners - Compact seminar on the entire medical device development process in compliance with the MDR
Die Themen - Introduction to medical devices and regulatory fundamentals - Classification and conformity assessment procedures - Clinical e…
G2/21 - Plausibility and Now?
Die Themen - G2/21: guidance on when a technical effect demonstrated by post-filed data can be taken into account - Structured toolbox for …
MSLs in Transition: Navigating Change in Europe
Die Themen - EU Regulatory Changes: AI Act, HTA, Pharmaceutical Package, and EHDS - key updates for MSL practice - Emerging Therapies and H…
Bank Accounting - Deep Dive HGB (German Commercial Code), special features IFRS, CSRD, VSME
Die Themen - Practical knowledge of current HGB: Deep dive - Current principles, knowledge and developments HGB - Special features and acco…
Global Regulatory Affairs Essentials - Key Strategic and Operational Aspects
Die Themen - Strategic Planning - Global Regulatory Collaboration - Health Technology Assessment (HTA) Integration - Global Regulatory Doss…
Patient Involvement in HTA
Die Themen - Evolving Role of Patient Advocates in EU HTA - Patient Engagement with NICE: Lessons from the UK - The Role of Patients in Ger…
How to Protect And Manage Trade Secret Assets
Die Themen - Evolving developments shaping the trade secret landscape - Disputes and enforcement - Why trade secret metadata matters - Less…
Quality Management and Process Optimization in Medical Affairs - Structuring business processes, ensuring quality documentation and complia…
Die Themen - Compliance & Business Process Management (BPM) in Medical Affairs - Business Process Management & Quality Documentation in Med…
IP Agreements: Research and Development Agreements
Die Themen - Contract research and R&D cooperation - Cooperation with universities - IP transfer I Non disclosure agreements - Choice of la…
IP Agreements: Patent License Agreements
Die Themen - Scope of license - License fees - Actions against infringers - Know- how protection - Cross-Licenses - Antitrust law - Patent …
All about ATMP - Development - Quality - CMC - Authorisation - Market Access
Die Themen - From blood, tissues & cells to ATMP - GMP and Module 3 requirements for ATMPs - Requirements for clinical and non-clinical dev…
