The establishment of clear roles and responsibilities within & between CRO and sponsor on who assesses monitors and documents risk management activities is critical to both compliance and success. Establishing effective communication plans for risk analysis and action plan responsibilities is of paramount importance in preventing problems and ensuring audit readiness.
Objectives of the Presentation
With Regulatory Inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming increasingly 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.
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 R & D projects you need to outsource. This course also covers 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.
Why Should you Attend
It is essential for industry to employ efficient and accurate strategies for monitoring outsourced clinical trials to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, and quality monitoring and risk minimization when outsourcing clinical trials to remain compliant.
Using a combination of theory and practical examples, this interactive course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge you need to ensure quality oversight.
Who will Benefit
- Understand how to effectively manage CROs / vendors used in the pharmaceutical industry
- Build an understanding of your responsibilities as the sponsor or the vendor: identifying the right level of oversight
- Discover tools and processes to manage CROs and other vendors
- Gain an insight for CROs/other vendors of what sponsors expect and how to meet their expectations
- Measuring CRO performance including metrics and key performance indicators
This course is designed for personnel involved in vendor/CRO oversight (including those working in Clinical Research, Regulatory Affairs, Pharmacovigilance, and Manufacturing ) in the pharmaceutical, biotechnology, medical device and biologic industries who use Contract Research Organizations (CROs) , Vendor Management, Global QA/Compliance, Contracts and Outsourcing. VPs, Directors, Managers and other personnel involved in selecting and managing CROs will benefit from this course. Outsourcing department staff, purchasing, finance and contract management staff who participate in the Request for Proposal (RFP) process will find this course a valuable introduction or refresher course focusing on best practice.