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Managing Vendor/CRO/CMO Oversight in the Pharma Industry


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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, Global QA / Compliance and also CRO / vendor / Consultant personnel. Outsourcing, 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. VPs, Directors, Managers and other personnel involved in selecting and managing CROs/Vendors will also benefit from this course. This course will also help professionals from CROs/Vendors/Consultants to work more successfully with Pharmaceutical, Biotechnology and Medical Device companies through gaining a much clearer understanding of their needs when outsourcing.

Details

Course Overview

This workshop is specifically designed for sponsoring pharma companies who are outsourcing critical practices to improve productivity. It will help you get to grips with effective CROs/Vendors management used in the pharma industry and your responsibilities as the sponsor. It will also show you how to clarify roles and responsibilities, focus on oversight preparation and planning. Most importantly it offers an in-depth insight into CROperformance measurement including metrics and key performance indicators.

Why you should attend

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.

Prices

TBC

Contact

Leigh White
info@management-forum.co.uk

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