FORUM Institut für Management GmbH: 83 Produkte
e-Learning: Common Technical Document and eCTD - including CMC requirements for marketing authorisation applications
Die Themen - CTD principles and structure - Format and content of module 1 - 5 CTD - CMC data required for module 3 (drug substance and dru…
Regulatory Affairs and GMP compliance in Eastern Europe - Considerations for the EAEU and Non-EAEU markets
Die Themen - Regulatory Framework and Requirements - Approval Processes and Documentation - Product Management and Maintenance - Quality Ma…
e-Learning: Patent Portfolio Generation and Management
Die Themen - Organising Patent Portfolio Generation - Organising Patent Portfolio Management - Budgeting Patent Portfolio Generation and Ma…
Webcast series: Global regulatory requirements for drug device combination products (DDCs) - Overview for the EU, US, China, and MENA region
Die Themen - Concept: Four weekly live webcasts à 3/2 hours with longtime experienced speakers - Regions covered: EU, US, China, and MENA r…
Global Regulatory Affairs Essentials - Key Strategic and Operational Aspects
Die Themen - Strategic Planning - Global Regulatory Collaboration - Health Technology Assessment (HTA) Integration - Global Regulatory Doss…
e-Learning: Medical Device Advisor §83 MPDG - e-Learning in 5 modules for non-German speaking employees
Die Themen - European Medical Device Law and its Application in Germany - Definition of a medical device is and how it is brought to market…
e-Learning: Leading agile and resilient teams - Coaching Strategies to climb mountains
Die Themen - Coaching strategies to facilitate positive outcomes - How to ensure high level of team performance - Effective coaching questi…
GenAI Patent Munich Spring Camp
Die Themen - Generative AI for patent search, drafting, prosecution, litigation and analysis - Legal requirements and technical realities -…
Variations in Europe - Practical Guidance on Classification, Submission and Current Regulatory Updates
Die Themen - Variation Regulation (inlcuding new features since 01.01.25) - Classification and submission (including new features since 15.…
Global CMC requirements: focus on Asia, Japan, and Eastern Europe - Covering aspects for small and large molecules
Die Themen - Regions covered: China, Japan, South Korea, India, Russia/EAEU - Pharmaceutical legislation - Additions and differences with r…
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…
Invent with AI Masterclass
Die Themen - Impact of integrating AI into the patent portfolio management process on an organization's innovation and IP strategy - Use of…
e-Learning: Stability Testing in the ICH Region - Stability testing for chemical and biological products in the ICH region
Die Themen - Module 1: Regulatory requirements - Module 2: Factors that influence stability testing - Module 3: Stability test requirements…
Abonnement: PharmaFORUM Webcast International - "Electronic Product Information (ePI): Global Developments and Regulatory Perspectives" 12 …
Die Themen - The evolving complexity of CMC documentation in global submissions - Regulatory Intelligence in a Global Context - Regulatory …
An Introduction for Pharmacovigilance Managers - Start your career in Drug Safety
Die Themen - Regulatory framework and EMA GVP modules - Management of side effects and signals - Benefit-risk assessment and risk managemen…
