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

This workshop will be of great value to those in the Pharmaceutical and Biotech industries. It is designed for those who are or will be directing/managing projects within their area of expertise and who need to get a clear understanding of the industry specific best practices as well as the project management best practices that apply to their projects. It is intended also for current project managers and others with cross-functional project management responsibilities in the Pharmaceutical and Biotechnology industries.

Typical Attendees include:

-Project Managers, Directors & Leaders
-Research and Development Scientists
-Preclinical Development Directors/Associates/Scientists
-Toxicologists/Pharmacologists/Directors of Pharmacology
-Clinical Trial Managers, Monitors & RA’s
-Physicians and Medical Liaisons
-Clinical Investigators and Study Coordinators
-Clinical Affairs Directors and Senior CRA’s
-Pharmacovigilance & Labeling Professionals
-Clinical Operations & Medical Affairs personnel
-Research & Development managers and support personnel
-Medical Affairs and Clinical Operations staff
-Regulatory Affairs professionals
-The course is also designed for product/marketing personnel who are involved in pre and post- launch planning and on-going management of the commercialization of products.

Learning Objectives

This course will provide a detailed understanding of the activities involved in Phases 3 and 4 of the Drug Development process. Attendees will leave the course with a thorough understanding of project management practices that will make the difference between a successful clinical trials and a trial that does not meet its objectives. Specifically, the course will address issues faced by those involved in the latter stages of pharmaceutical R&D, including product launch and post-commercialization. The emphasis is on practical application of project management fundamentals within that environment.

By the end of this workshop, participants will be able to:

-Understand the overall Drug Development process and the unique aspects of Phase 3, 4 and Life Cycle Management
-Apply Best Practices in Project Management to Phase 3 and 4 Trials
-Manage a development project team and recognize the specific needs and leadership skills required for this stage of the drug development process
-Manage, Monitor and control the project timelines and budgets
-Identify and manage Outsourcing aspects of the project
-Select the best drug delivery systems and incorporate these decisions into the plan.
-Create and maintain successful partnerships with CROs and other organizations
-Manage Project Risks Proactively.
-Manage Adverse Events Reporting and Protocol Deviations
-Prevent and manage Fraud and Misconduct

Course Description

Getting to market more quickly can translate into millions of dollars per day in additional revenue and quality problems that stall approved products have a significant effect on the bottom line. The advantages of conducting Phase 3 and 4 trials efficiently include cost savings and faster speed to market.

This course focuses specifically on the best practices for and managing these stages in the Drug Development process. It combines best practices in product development and clinical trials with GCP guidelines and FDA regulations. It will provide each participant with a list of practices to follow and a list of pitfalls to avoid. Participants will learn the essentials of clinical research including complying with international regulatory guidelines, optimizing patient recruitment and guaranteeing high quality clinical data.

Specific aspects that will be addressed are: making educated outsourcing decisions and site selection, minimizing patient recruitment challenges, improving data management procedures to produce high quality data and employing a successful Electronic Data Capture system. The course is presented in a dynamic, interactive manner to facilitate learning and retention.