FORUM Institut für Management GmbH: 38 Produkte
Artificial Intelligence in Pharmacovigilance - Exploring Today, Shaping Tomorrow
Die Themen - Introduction to AI and its applications in pharmacovigilance - Legal and regulatory frameworks - AI to support rule-based (det…
Global variations and lifecycle management - Series of Interactive Live Webcasts
Die Themen - Strategic Planning for Variation Submissions - Lifecycle Management Challenges - Global CMC Strategy & Regulatory Overview - C…
RMP and PSUR in lifecycle management: An art, not a miracle - Advanced concepts for effective risk management
Die Themen - RMP and PSUR in the drug lifecycle - Additional risk minimisation measures: GVP-Moduls XVI (Rev 3) and new Addendum I - Impact…
Global Pharmacovigilance Inspection Readiness - Strategies for successful PV (remote) inspections in Germany, Europe and worldwide
Die Themen - Fundamentals: regulations, occurrence, types and aims - Strategic planning and preparation for a (remote) GVP inspection - Rep…
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…
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 …
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…
