FORUM Institut für Management GmbH: 83 Produkte
CMC Management in Regulatory Affairs - Quality data for marketing authorisation in Europe
Die Themen - Regulatory requirements in the EU and the ICH region - Update on the new (Draft) ICH M4Q(R2) - Essential quality data for mark…
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…
e-Learning: Medical Devices Basics - A Quick Introduction - E-learning with 3 modules: Medical Device Law, Development and Conformity Asses…
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: GDP - Basic Training - Basic training to understand the requirements of GDP in today's pharmaceutical industry
Die Themen - Defining GDP - From regulations to implementation: quality management - Key roles in the GDP environment - GDP in practice: st…
e-Learning: Working with the Works Council in Germany
Die Themen - Legal framework, main principle, formation and types of the works council - Legal position of the works council and of its mem…
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…
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…
Amsterdam Masterclass: EPO Oppositions & Appeals - Best Practices on the Proceedings on 1.5 Days
Die Themen - Opposition Proceedings in the light of RPBA: drafting notice of opposition anticipating admissibility hurdles, substantive exa…
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…
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…
e-Learning: EU Variation System and Procedures - Classification, Grouping, Worksharing & Submission
Die Themen - Module 1: Overview of the EU law and Guidelines - including Commission Delegated Regulation (EU) 2024/1701 - Module 2: Classif…
Generative AI Workshop for Patent Practitioners
Die Themen - The potential of generative AI for daily patent work - Generative AI for the drafting of patent applications - The application…
Pharmacovigilance Auditing - Planning and conducting GVP Audits
Die Themen - Qualifications and responsibilities according to GVP Module IV - Conducting effective interviews - Auditing of PV documents, c…
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…
