Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process

Who Should Attend

This course will provide value to those in the Pharmaceutical, Biotech and Medical Device industries who manage or direct projects within their functional area related to Clinical Trials.  It will also benefit personnel that need an understanding of industry specific and project management best practices that should apply to their project.  This course is also relevant for current project managers and others who may have cross-functional project management responsibilities.

Typical Attendees include: 

• Project Managers, Directors and Leaders
• Clinical Investigators and Study Coordinators
• Clinical Operations Directors and Senior CRA’s
• Clinical Trial Managers, Monitors and Associates
• Medical Affairs and Clinical Operations Professionals
• Pharmacovigilance and Labeling Professionals
• Physicians and Medical Liaisons
• Regulatory Affairs Professionals
• Preclinical Development Professionals
• Research and Development Scientists
• Product and Marketing Personnel in Pre- and Post Launch planning

Learning Objectives

The course provides a thorough understanding of the activities involved during Phase 3 and 4 of Drug Development.  The intent is to provide detailed knowledge of project management practices, skills and tools that will make the difference between a successful clinical trial and one that does not meet its goals.  The course will focus on issues that impact late stage R&D, including product launch and commercialization. By the end of the course, participants should be able to: 

• Understand the overall drug development process and the unique aspects of Phase 3, 4 and Life Cycle Management
• Apply project management best practices to clinical trials
• Manage a development project team and recognize team needs and leadership skills required for this stage of the drug development process
• Understand GCP guidelines, FDA regulations and ICH guidelines
• Understand and manage the challenges of clinical trials outside the USA
• Manage, monitor and control clinical trial timelines and budgets
• Identify and manage outsourcing aspects of the project
• Select the best drug delivery system and incorporate into the project plan
• Develop and maintain partnerships with CRO’s and other support organizations
• Actively manage project risks and opportunities
• Manage adverse event reporting and protocol deviations
• Prevent and manage fraud and study misconduct

Course Description

Speed to market is the key to driving product revenue.  Managing the quality of the Phase 3 and 4 activities will impact project timing and budget and have a significant effect on the bottom line. Project managers must understand the late stage development process and the key aspects of product submission, approval and launch. Participants will learn best practices for developing and managing these trials and submissions within GCP guidelines and FDA regulations.

The course will discuss the challenges associated with outsourcing, site selection, patient recruitment and data management. Clinical research that complies with international and domestic regulatory guidelines and produces high-quality data for submission is the goal. The course is interactive and designed to allow for the exchange of ideas with peers in addition to learning from the instructor.