FORUM Institut für Management GmbH: 83 Produkte
The EU Qualified Person for Pharmacovigilance (EU QPPV) - The intensive beginner's course on legal foundations and practical application
Die Themen - Legal framework, liability, and legal protection - Regulatory requirements for day-to-day practice - Maintaining oversight of …
Leveraging AI in Evidence Generation and Market Access
Die Themen - Dossier Writing - Use cases for AI support - Using AI in Systematic Literature Review (SLR) - LLMs for describing and evaluati…
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…
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…
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…
