Course offering number:0905-703
Course ID:
2298
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Effectively Managing CROs
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training will benefit professionals in the pharmaceutical industries who manage Contract Research Organizations (CROs) who have been contracted for any projects involved in the process of new product development. Programs involving: Pre- and Non- Clinical Studies, Clinical Trials in Phases 1, 2, 3, 3b and 4, and Manufacturing require continuous management expertise in order to bring these programs to successful completions. The course will be especially valuable to:
• Managers who are responsible for overseeing programs
contracted to CROs in the non and pre-clinical, clinical and
manufacturing areas
• Vice Presidents, Directors and Administrators responsible
for all programs necessary to bring new pharmaceutical
products to market on time and within budget
• CRO personnel who work with Sponsors who are
developing pharmaceutical products in order to
understand the expectations and demands based
on their contractual agreements
Description
This 90-minute accredited online training course will detail the procedures and skills needed for Sponsors who develop pharmaceutical products, drugs, biologics or devices, how to successfully manage CROs. This course will guide the learner in how to manage and collaborate with CROs to best achieve the objectives of each project assignment. Each area in the process of new pharmaceutical product development will be addressed as to the responsibilities of the Sponsor and CRO obligations in conjunction with, SOPs, GLPs, GCPs, and GMPs. Recommendations and contingency plans for handling project failures, program lags, and non-compliance of global agency regulations will be presented. Topics to be covered:
Module 1:
• Confidentiality
• Legal Requirements
• Managing Pre-Clinical CROs
• Managing Clinical CROs
Module 2:
• CRO/Sponsor Responsibilities
• SOPs
• Assuring Data Collection
• CRO-Sub-Contractors
Module 3:
• Sponsor/CRO Communications
• Co-Monitoring
• Managing Regulatory Compliance
• Managing GMPs
Question and Answer Session