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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

An invaluable workshop for Sponsors and CROs / CMOs / Vendors

Topics to be Covered Include:-

  • Understand how to effectively manage CROs / Vendors used in the Pharma Industry
  • Build an understanding of your responsibilities as the sponsor or the vendor: Identifying the right level of management and oversight
  • Using a robust CRO / vendor selection process
  • 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
  • Sharing experiences and lessons learned from other Pharma professionals managing CROs/other vendors

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.

Contact

Leigh White
info@management-forum.co.uk

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