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.
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:
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 Request for Proposal (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.
Background to the CRO industry and meeting regulatory expectations
Effective oversight: how CROs and sponsors can work successfully on R&D projects
Vendor/CRO selection – an overview of selection and bidding processes including assessing the competency of the CRO/vendor
Managing vendor/CRO project set-up
Oversight preparation, planning and clarity of roles and responsibilities
Ongoing oversight and management
** Agendas for meetings with CROs to include update reports
** Discussion of billing issues with CROs
** Deliverables and analysing performance trends
** Troubleshooting problems with CROs – common problems and possible solutions
End of project oversight: reviewing CROs during and at the end of the project
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials