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.
This workshop is specifically designed for sponsoring pharma companies who are outsourcing critical practices to improve productivity. It will help you get to grips with effective CROs/Vendors management used in the pharma industry and your responsibilities as the sponsor. It will also show you how to clarify roles and responsibilities, focus on oversight preparation and planning. Most importantly it offers an in-depth insight into CRO performance measurement including metrics and key performance indicators.
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.
Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
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
Dr Dr. Laura Brown,
Pharmaceutical Management and Training Consultant ,
University of Cardiff
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA.
She has more than 19 years experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing. Laura has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Board of the Good Clinical Practice Journal. In addition to her scientific qualifications, she has a degree in psychology and an MBA.
Laura is co-author of several books on management including Developing the Individual, The Ultimate Book of Business Skills and Pharmaceutical Project Management.
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.
The Rembrandt Hotel
11 Thurloe Place
Opposite V&A Museum.
Nearest underground station: South Kensington.