Vendor Oversight and Quality Management in RA and PV

• Legal requirements and guidelines
• Local vs global outsourcing
• Quality management and quality assurance in outsourcing activities
• Subcontracts, SOPs, KPIs, training and auditing
• Systems, budget control, the communication plan and more

Who should attend

Outsourcing in pharmacovigilance (PV) and regulatory affairs (RA) is standard practice. But the main responsibility for ensuring that the services meet regulatory requirements remains with the marketing authorisation holder (MAH). This raises a number of questions, which our experts will answer.

• When, why and what does it make sense to outsource?
• Who is responsible for what?
• How do I find the appropriate service provider?
• What contractual agreements should I insist on?
• How do I integrate the contractual partner into my QMS?
• What training do my service providers need?
• What is an oversight programme and which databases can/should I use?
• Which KPIs are useful and how do I monitor them?
• How do service provider audits work?

This seminar will enable you to

• find and qualify the appropriate PV and RA vendors.
• establish and improve your working relationships with new and existing service providers.
• define the requirements for an effective (global) provider monitoring programme and know how to implement it.
• set up and monitor appropriate KPIs for supplier performance.
• define the key elements of supplier contracts.