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Managing Vendor/CRO Oversight for Pharmaceutical Professionals

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 in the to ensure for successful vendor selection, contract considerations, and oversight of CROs to ensure compliance with the expectations of inspections. Participants will learn how to prepare a Request for Proposal (RFP) and use that to find, evaluate and select the right CRO for the work they need to outsource. This course will also cover the techniques for successfully managing CROs and the shared responsibilities required by the sponsor and the service provider. Managing CRO performance issues will also be be discussed.

Turning 'Theory' into 'Practice'?

This interactive course will build upon the foundations of CRO management methodology, technical tools and techniques and develop the essential skills that are critical for ensuring the success of your business. This course will enable you to apply practical CRO management techniques to your own pharmaceutical projects. Our CRO management training will be interactive and applicable to your daily work. Participants are encouraged to bring a current real cases to the course to which they can apply the concepts and techniques, thus reaping the benefits immediately and enhancing the learning experience.

Who should attend?

This course is designed for personnel involved in vendor/CRO oversight (including those working in Clinical Research, Regulatory Affairs, Pharmacovigilance, and Manufacturing ) in the pharmaceutical, biotechnology, medical device and biologic industries who use Contract Research Organizations (CROs) , Vendor Management, Global QA/Compliance, Contracts and Outsourcing. VPs, Directors, Managers and other personnel involved in selecting and managing CROs will benefit from this course. Outsourcing department staff, 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.

Key areas to be covered in the programme and documentation

Background to the CRO industry and meeting regulatory expectations
• Outsourcing today
• Different models of outsourcing
• The potential benefits and drivers of outsourcing
• Examine EU and FDA expectations re outsourcing

Working effectively with CROs
Challenges of working with CROs to ensure effective management (group discussion and sharing experiences)

CRO selection – an overview of selection and bidding processes including assessing the competency the CRO
• All or none – What should you outsource?
• Sponsor responsibilities
• Writing the RFP
• Evaluating responses to the RFP
• Pre-Qualification of vendors and vendor audits
• Contract negotiations and partnering with CROs

Managing CROs 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 and maintain quality of the Quality
• Briefing the CRO
• Clarity of roles and responsibilities

Preparation, planning and clarity of roles and responsibilities with CROs
• Project set-up, planning and initiation with CROs
• 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 they can set up in order to manage regular meetings(eg weekly/biweekly or as required) with CROs

On-going Management of CRO continued
• Tracking and measuring CRO progress and performance
• On-going training and integrating new CRO staff
• Auditing CROs
• Maintaining effective communication with the CRO
– Progress and update meetings/TCs with CROs
– Agendas for meetings with CROs Update reports and reporting progress of CROs.
– Discussion of billing issues with CROs, and time to reconcile the invoiced hours vs the actual number of hours by the CROs.
– Deliverables and analysing performance trends

Troubleshooting problems with CROs
• Common problems and possible solutions to be discussed

Review of CROs during and at the end of the project
• Review meeting
• Feedback and learning’s for future pharma projects using CROs/vendors

Benefits to you

• Understanding how to effectively manage CROs/Vendors
• Build an understanding of your responsibilities as the sponsor: identifying the right level of management and oversight
• Using a robust CRO/Vendor selection process
• Understanding tools and processes to manage CROs
• Measuring CRO performance including metrics and key performance indicators
• Sharing experiences and lessons learned from other pharmaceutical professionals managing CROs

Companies already benefiting include:

Duration of Course

2 Day Course

Course details

10th & 11th April 2015, London, PT3025

Looking to train larger teams in this subject?

dzingim@marcusevansuk.comTailored in-house/in-company training courses and bespoke strategy workshops designed and delivered on-site throughout Europe according to your specific requirements.

All management, personal development and project management public courses featured in our Course Directory are also delivered on an In-Company basis.

Click Here for information on how this course can be delivered for you as an In-Company Training Solution

 


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Testimonials

"This course will allow my company to develop its existing strategies to a much greater and hopefully profitable level."

Managing Director, Tarmac