Outsourcing & Vendor Oversight in Regulatory Affairs

• Foundations of outsourcing in regulatory affairs
• Vendor selection & risk assessment
• Set-up & management of outsourced processes
• Maintaining oversight & ongoing compliance

Who should attend

• 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.

This 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.

• You get a clear decision logic for what to outsource in regulatory affairs.
• You learn a lean, risk-based approach to vendor selection and qualification.
• You can set up a governance system fast.
• You improve ongoing oversight and compliance via monitoring, change control and vendor reviews.