Managing Vendor/CRO Oversight Master Class, Online 12-13 September 2023
• 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
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.
Who should attend?
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 andglobal 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.
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.