Vendor oversight in a regulatory environment - Regulatory affairs, vigilance and other GxP areas

Aims and objectives

Many healthcare companies are choosing to outsource regulated activities in regulatory affairs, vigilance and other GxP areas. They remain responsible for ensuring that the services are in compliance with contractual and regulatory requirements. Our seminar and workshop will explain how to implement an effective regulatory vendor oversight programme in your company and how to monitor quality, KPIs, budget and compliance.

Who should attend?

This seminar addresses the needs of those working in the pharma and healthcare industries. It will particularly benefit the following departments involved in outsourced regulatory activities:

- Regulatory Affairs;

- Pharmacovigilance;

- QA and QC; and

- Business Development.

Providers are also invited to attend this seminar to exchange experiences. The optional workshop on day 2 will provide practical insights into operational issues and specific cases.

Your benefits

After the seminar, you will be able to:

- find and qualify the right vendor;

- identify the necessary elements for an effective worldwide regulatory vendor oversight programme

- define and monitor KPIs for vendor performance; and

- effectively oversee the important elements of vendor contracts.