Outsourcing and Vendor Management in Pharmacovigilance - Keeping track of your service providers

Die Themen

- General principles of outsourcing - Vendor choice and qualification - Contractual considerations - Quality management and quality assurance - Workshops on KPIs and risk-based audit planning

Ziele

Outsourcing in pharmacovigilance (PV) is common practice. However, the main responsibility for ensuring that the services meet regulatory requirements remains with the marketing authorisation holder (MAH). This raises a number of questions that our experts will answer:
- When, why and what makes sense to outsource?
- Who is responsible for what?
- How do I find the right service provider?
- What contractual agreements do I have to insist on?
- How do I integrate the vendor into my QM system?
- What training do my service providers need?
- Which KPIs are useful and how do I monitor them?
- How should audits of the service provider be conducted?

Wer sollte teilnehmen?

The training course is aimed at employees and managers in the pharmaceutical industry who are involved in outsourcing or monitoring PV activities to external service providers. The seminar is also of interest to PV service providers.