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Press Release

Managing Vendor/CRO/CMO Oversight in the Pharma Industry (London, United Kingdom - October 4th & 5th, 2018) - Research and Markets

Research and Markets
Posted on: 21 Dec 17

The "Managing Vendor/CRO/CMO Oversight in the Pharma Industry" conference has been added to Research and Markets' offering.

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.

Agenda:

Introduction and Objectives

Background to the CRO Industry and Meeting Regulatory Expectations

  • Outsourcing today for the Pharma industry
  • Different models of outsourcing in the Pharma industry
  • The potential benefits and drivers of outsourcing
  • Examine EU and FDA expectations re. outsourcing for the Pharma industry

Effective Oversight: How CROs and Sponsors can Work Successfully on R & D Projects

  • Challenges of working with CROs to ensure effective management and oversight

Vendor/CRO Selection - an Overview of Selection and Bidding Processes including Assessing the Competency of the CRO / Vendor

  • All or none - what should you outsource?
  • Sponsor responsibilities for the clinical study vs the CRO
  • Writing the RFP
  • Evaluating responses to the RFP
  • Pre-qualification of vendors and vendor audits
  • Contracts, negotiations and partnering with CROs

Managing Vendor/CRO Project Set Up

  • Building effective relationship with the CRO while providing sponsor oversight and a working escalation of issues
  • How to set the stage so the CRO focuses on Quality - the quality/oversight plan
  • Briefing the CRO to be able to work successfully in the Pharma industry
  • Clarity of roles and responsibilities

Oversight Preparation, Planning and Clarity of Roles and Responsibilities

  • Project set-up, planning and initiation with CROs for R & D projects
  • Training CROs
  • Which SOPs should CROs use?
  • Clarity and communications with CROs
  • Risk assessment tools
  • Tools and techniques for managing CRO performance - understand the KPIs / /dashboards / report processes that can be set up in order to manage regular meetings with CROs / Vendors

On-Going Oversight and Management

  • Tracking and measuring CRO progress and performance
  • On-going training and integrating new CRO staff
  • Auditing CROs
  • Maintaining effective communication with your CRO
  • Progress and update meetings / TCs with CROs
    • 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

  • Review meetings
  • Feedback and learning's for using the CRO in the future

Review and Final Discussion

For more information about this conference visit https://www.researchandmarkets.com/research/vrvbgv/managing?w=4

View source version on businesswire.com: http://www.businesswire.com/news/home/20171221005438/en/

Business Wire
www.businesswire.com

Last updated on: 21/12/2017

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