Project Management for Phase 1 & 2 Clinical Trials

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 and Leaders
-Clinical Investigators and Study Coordinators
-Clinical Affairs Directors and Senior CRA’s
-Research and Development Scientists
-All Medical Affairs and Clinical Operations Professionals
-Regulatory Affairs Personnel
-Preclinical Development Director/Associate/Scientist
-Toxicologist/Director of Toxicology
-Pharmacovigilance & Labeling Professionals
-Pharmacologist/Director of Pharmacology
-Clinical Trial Managers, Monitors and Associates
-Physicians and Medical Liaisons

Learning Objectives

This course will provide a thorough understanding of the activities involved during the Phase 1 and 2 stages of Drug Development. The intent of the course is to provide detailed knowledge of the project management practices that will make the difference between a successful clinical trials and a trial that does not meet its goals.

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

-Understand the overall Drug Development process and the unique aspects of Phase 1 & 2
-Apply Best Practices in Project Management to Clinical Trials
-Manage a development project team and recognize the specific needs and leadership skills required for this stage of the drug development process
-Refine the Target Product Profile and position the product for future launch
-Understand GCP Guidelines, FDA Regulations and ICH Guidelines
-Manage the challenges associated with implementing clinical trials outside of the USA
-Select between the main two European routes of submission
-Define accurate clinical trials timelines and budgets
-Achieve high quality clinical data and Optimize Study Logistics
-Define and manage enrollment toward success
-Successfully manage clinical supplies in your project plan
-Manage Adverse Events Reporting and Protocol Deviations
-Prevent and manage fraud and misconduct

Course Description

Efficient management of early phase clinical trials can significantly impact the viability of a drug or device. In such an environment, project managers must be nimble and adept at change. Clinical Trials for Phase 1 and phase 2 are significant milestones toward success. This course focuses specifically on the best practices for developing and managing these trials. 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. This is based on several hundreds of clinical trials conducted by small and large biotech companies as well as pharmaceutical companies.

This training will also explore the challenges encountered when conducting trials outside of the United States and discuss language, cultural differences, medical practices and much more. We will also discuss how to respond to specific situations such as an enrollment not meeting expectations or the quality of the trial data being “too perfect”. The course is presented in a dynamic, interactive manner to facilitate learning and retention.