Training Overview
With regulatory inspectors increasingly finding issues with vendor oversight by sponsor
organisations, 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 manage them
efficientlyandeffectivelywillhelptoensurecompliancewiththeregulator’sexpectations.
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 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 useful to CROs/other vendors and consultants to understand how
to work effectively with sponsor organisations.
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 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.
Trainer
