Managing Service Providers including CRO and CMOs oversight to comply with ICH GCP R3

With regulatory inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming even more important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities. A company’s ability to identify and select the right CRO/ vendor for the right project and manage them efficiently and effectively will help to ensure compliance with the regulator’s expectations.

On this course you will learn how to prepare a request for proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource. You will also cover the techniques for successfully managing CROs/ vendors and the shared responsibilities required by the sponsor and the service provider. Managing CRO performance issues will also be discussed.

The course is equally useful to CROs/other vendors and consultants to understand how to work effectively with sponsor organisations.

Benefits of attending:

• Understand how to effectively manage CROs/vendors used in the pharma industry
• Build an understanding of your responsibilities as the sponsor and identify the right level of management and oversight
• Discuss how to put in place a robust CRO/vendor selection process
• Discover tools and processes to manage CROs and other vendors
• Measure CRO performance including metrics and key performance indicators (KPIs)