Course Description - Course runs 9:00 to 5:00 both days (Includes Breakfast & Lunch)

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.

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.

Kay Monroe

Specialties: Quality, Management

Kay Monroe is Acting Executive Director of Zagaya. This non-profit – specializing in Malaria – works to bring innovative technologies to the problems of global health in the developing world.

Ms. Monroe has spent over 25 years with biotechnology and pharmaceutical companies around the world; working on global project teams from Research through Phase IV and introducing Project Management Offices into several companies. She has extensive experience in product lifecycles and the creation of submission documents. In addition, she has sourced both items and processes for pharmaceuticals, biologics and devices.

Ms. Monroe has held positions as Vice President of Operations, Project Management and Quality Assurance in companies such as Lundbeck, Synarc and Genentech. She has extensive experience in the start-up environment with such companies as Cerus, Dynavax and Amyris.

Ms. Monroe received her Bachelors of Science in Animal Science from UC Davis and her MBA from Golden Gate University.

Courses:

• Clinical Document Management - A Trial-by-Trial Approach to Compliance
• Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices
• Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
• Writing Effective Standard Operating Procedures and Other Process Documents
• Writing in the Regulated Environment When English Is Your Second Language