Managing Vendor/CRO/CMO Oversight in the Pharma Industry

Management Forum

Course

In The Rembrandt Hotel, London

£ 1,499 + VAT

The best Other Science courses

See all

See all

Description

  • Type

    Practical seminar

  • Level

    Intermediate

  • Location

    The rembrandt hotel, london

  • Class hours

    8h

  • Duration

    2 Days

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

Facilities

Location

Start date

The Rembrandt Hotel, London (London)
See map

Start date

On request

Start date

On request

About this course

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.

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.

Questions & Answers

Add your question

Our advisors and other users will be able to reply to you

Who would you like to address this question to?

Fill in your details to get a reply

We will only publish your name and question

Reviews

Subjects

  • Meetings
  • Project
  • Industry
  • Pharma
  • Contract research organization
  • Management
  • Pharamaceutical marketing
  • Life Science
  • Medical Devices
  • Training planning

Teachers and trainers (1)

Dr Laura Brown

Dr Laura Brown

Course Director, School of Pharmacy

Course programme

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

See related categories

Managing Vendor/CRO/CMO Oversight in the Pharma Industry

£ 1,499 + VAT

The best Other Science courses

See all

See all