Managing Vendor/CRO/CMO Oversight in the Pharma Industry
Course
In The Rembrandt Hotel, London
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
Start date
Start date
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.
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
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
Managing Vendor/CRO/CMO Oversight in the Pharma Industry