Outsourcing & Vendor Oversight in Regulatory Affairs - Practical half-day training to strengthen vendor selection, performance management and oversigh

- Foundations of outsourcing in regulatory affairs - Vendor selection & risk assessment - Set-up & management of outsourced processes - Maintaining oversight & ongoing complianceOverview of RA outsourcing & vendor oversight: risk-based vendor selection, governance and compliance controls. Practical and compact in just half a dayLernzieleThis half-day seminar provides a practical introduction to outsourcing and vendor oversight in regulatory affairs. Based on a structured, step-by-step approach, you learn how to decide when outsourcing makes sense, how to select and qualify vendors in a risk-based way, and how to set up governance, communication and performance management for outsourced RA activities.- The seminar also addresses how to maintain effective oversight throughout the collaboration - including monitoring parameters, change control, and regular vendor reviews (up to audit and requalification). - By the end, you will have a clear framework and concrete steps to strengthen compliance and reliability in day-to-day vendor management.Zielgruppen- RA professionals new to outsourcing who need a practical framework for vendor selection and oversight. - RA professionals with outsourcing experience who want to update and deepen their know-how. - QA, PV, project management, procurement and other adjacent functions supporting the management of outsourced regulatory activities.- A solid background in EU marketing authorisation processes is required.