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.

COURSE AGENDA
DAY ONE

Drug Development Process and Project Teams

Outline of the Drug Development Process
How does Project Management fit?
Best Practices in Project Management applied to the Drug Development Process and Current Trends
Project Core Teams, Project Managers and Leaders
Leadership Skills

Target Product Profiles and the Clinical Trial Process

Review the Target Product Profile
The Clinical Trial Process

Updating the Target Product Profile and the Project Objectives

Target Product Profile versus Labels
The value of Phase Gate related objectives
How to truly measure success

Managing the Project: Timelines and Budgets

Generally accepted metrics
Budgets, Grants, Contracts (selecting the best option)
Creating a Timeline and Critical Path
Impact of Outsourcing Decisions

DAY TWO

Phase IV - What and Why

Best Practices
Recent Trends

Life Cycle Management

Does the Commercialization phase require new project plans, project managers, project leaders, metrics ...?
Redefining your project teams
Ensuring a smooth transition

Outsourcing and Drug Delivery Systems

Outsourcing Trends
Clinical Supplies Outsourcing
Developing and Maintaining a High Performance Partnership
Benefits and Strategies around Drug Delivery Systems

Partnering with a CRO

Best Practices
Lessons Learned from several true stories

Past Participants' Comments

"The course director was a very good instructor. Her knowledge was very broad which was refreshing and her speaking style kept me engaged."
Kathleen G., Sr. Process Engineer, Gilead Science

"I really enjoyed the small class environment. It allows you to become very engaged and the class can move at a pace based on the knowledge and skill set of the entire class!"
Nicole L., Program Manager, Dyax

"The instructor was very knowledgeable on the subject and made the course more interesting by providing real life examples that directly applied to the course materials."
Amanda S., Sr. Analytical Chemist, Merck &Co.

"Excellent, small focused course with relevant case studies and lively discussions. I enjoyed it very much!"
Associate Director, Portfolio Management, Berlex

There are no course dates scheduled at this time. Please call +1-610-688-1708 for more information.