Course overview
With the implementation of ICH GCP E6(R3), regulators are placing increased emphasis on sponsor oversight of outsourced activities, risk-based management and demonstrable control of service providers. Sponsors must now be able to evidence proportionate oversight and informed decision-making throughout the clinical lifecycle.
Additionally, as regulatory inspectors continue to identify deficiencies in vendor oversight by sponsor organisations, the pharmaceutical industry must place even greater emphasis on implementing 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.
CPD Hours: 12
Course Content
- Day 1
- Background to the CRO industry and meeting regulatory expectations
- Oversight of CROS/Vendors and meeting regulatory inspectors’ expectations
- Building an effective relationship
- Vendor/CRO selection - an overview of selection and bidding processes
- Day 2
- Vendor/CRO selection - an overview of selection and bidding processes - continued
- Managing vendor/CRO project set-up
- Ongoing oversight and management
- End of project oversight: reviewing CROs during and at the end of the project
Speakers
Laura Brown
Dr Laura Brown is an independent pharmaceutical QA and training consultant and the Senior Lecturer for the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura is an expert in outsourcing pharmaceutical research projects including CRO selection, management and oversight audit and management. She has more than 20 years’ experience in the pharmaceutical industry in a number of senior roles and has worked for several companies, including GSK, Hoechst Marion Roussel and Phoenix International in outsourcing pharmaceutical projects. She has worked in several vendor selection and management roles which have included reviewing quality and performance of CROs and has advised companies on how to implement quality systems for CRO selection and management.
