Introduction:

With regulatory inspectors increasingly finding issues with vendor oversight by sponsor organizations, 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 managing them efficiently and effectively will help to ensure compliance with the regulator’s expectations.

In 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 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 Vendor performance issues will also be discussed.

The course is equally valuable for CROs/other vendors and consultants to understand how to work effectively with sponsor organizations.

This course is designed for personnel involved in CRO/vendor oversight in the pharmaceutical, biotechnology, animal health and medical device industries including those working in clinical research, regulatory affairs, pharmacovigilance, manufacturing, clinical outsourcing, contracts, quality, clinical operations, vendor management and global QA/compliance. It will also be relevant for outsourcing, purchasing, finance and contract management staff who participate in the RFP process who will find this course a valuable introduction or refresher course focusing on best practice. This course will also help CRO/vendor personnel to work more successfully with pharmaceutical, biotechnology and medical device companies through gaining a much clearer understanding of their needs when outsourcing.

Key Takeaways:

• Understand Vendor management Oversight methodology and documentation.

• Discover how you can address inspection findings with Vendor Oversight

• Understand how to manage CROs/vendors used in the pharma industry effectively

• Build an understanding of your responsibilities as the sponsor

• Discuss how to put in place a robust CRO/vendor selection process

• Discover tools and processes to manage CRO/ vendors

• Measure CRO performance including metrics and key performance indicators (KPIs)

• Avoid problems of vendor oversight

• Share best practices for Vendor Oversight and Management

Trainer:

Nelle Stoquart Clinical Operation expert and trainer at Solutionelle. Experienced Project Manager and Instructor with a demonstrated history of working in the professional training & pharmaceutical industry. Skilled in Vaccines, Training Delivery, Software Documentation, CRO Management, Clinical Project Management, Risk Management, Risk Based Monitoring and Oncology Clinical Research.