The Center for Professional Innovation & Education, Los Angeles, CA
June 16 & 17, 2011
Who Should Attend This two-day seminar is designed for personnel in the pharmaceutical, biotechnology, medical device and biologics industries who use Contract Research Organizations (CROs) in the process of developing their products for FDA approvals. Attendees should have a basic knowledge of the drug, device or biologics development processes and a need to understand what is involved in outsourcing non-clinical and clinical research to CROs. 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 RFP process will find this seminar a valuable introduction or refresher class. CRO administration and management, who are involved in business development and operations, will gain a thorough understanding of what the pharmaceutical industry is seeking from CROs.
Learning Objectives The challenge facing product development companies today is to maintain or increase product quality while dramatically reducing costs and development lead times. A company’s ability to identify and select the right vendor for the right job and manage the vendor efficiently and effectively will help them manage this challenge. Participants will learn how to write a Request for Proposal (RFP) and use that to find, evaluate and select the right CRO for the work they need to outsource. Methodology for comparing and contrasting vendor responses to the RFP will be discussed. Participants will learn techniques for successfully managing CROs and the shared responsibilities required by the sponsor and the service provider.
Course Description
This course will provide the attendees with the specific methodology and management techniques to successfully outsource pharmaceutical programs that should then be more likely to be completed on time, within budget, and most importantly, with a high level of quality and performance. Participants will learn how the current external and internal forces are shaping the way projects will need to be delivered to be competitive and cost efficient given the state of the industry. The following topics will be discussed: - Types of CROs
- All or none - What should you outsource?
- How the FDA views CROs
- Sponsor responsibilities
- Writing the RFP
- Evaluating responses to the RFP
- Pre-Qualification of vendors and vendor audits
- Contract negotiations and partnering with CROs
- Managing the CRO
The processes in managing CROs, including study plans, in-field site visits, preparation for inspections, and monitoring evaluation programs will be discussed. Progress and conditions for terminating the services of a CRO will be analyzed along with the overall requirements of data quality assurance. Solutions to problem assessment and correction involving all outsourcing projects along with the legal requirements of sponsors and CROs are included in the presentations.
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