Project Management for Phase 1 & 2 Clinical Trials ™ Blended Learning Program

Please Note: This course is a "blended learning" program, which combines on-line training with classroom instruction. Prior to attending the classroom portion of the course, you will be provided access to online prerequisite training. By having all attendees complete the course's on-line component, the Course Director will have access to everyone’s training results and will be better able to tailor the classroom curriculum to the specific mix of attendees. Upon registration, you will receive instructions to log-in to the online portion of the course. This "blended learning" approach significantly enhances the educational value of the training program.

Who Should Attend

This course is an overview designed for those in the Pharmaceutical, Biotech and Medical Device industries who will manage or direct projects within their functional area related to Clinical Trials. It will also benefit those who need an understanding of industry specific and project management best practices that should apply to their project. This course also applies 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

Learning Objectives

The course provides a thorough understanding of the activities involved during the Phase 1 and 2 stages of Drug Development. The intent is to provide detailed knowledge of the project management practices, skills and tools that will make the difference between a successful clinical trial and one that does not meet its goals. By the end of the course, participants should be able to do the following:

Understand the overall drug development process and the unique aspects of Phase 1 and Phase 2
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
Refine the target product profile and position the drug for future submission, approval and launch
Understand GCP guidelines, FDA regulations and ICH guidelines
Understand and manage the challenges of clinical trials outside the USA
Develop accurate clinical trial timelines and budgets
Achieve high quality clinical data and optimize study logistics
Manage clinical supplies in your project plan
Manage adverse event reporting and protocol deviations
Prevent and manage fraud and study misconduct

Course Description

Efficient and effective management of Phase 1 and 2 clinical trials can significantly impact the time, scope and budget for the development of a drug or device. Project managers must understand the development process and the key aspects of Phase 1 and 2 in order to act, react and adapt to change when the program moves forward and new data is acquired. Successful completion of Phase 1 and Phase 2 clinical trials are key project milestones. This course focuses on the best practices for developing and managing these trials within GCP guidelines and FDA regulations.

The course will discuss the challenges associated with clinical trials run outside the United States and identify key differences, common pitfalls, and cultural differences. Guidance for the how-to as well as problem-solving for specific situations such as slow enrollment, high screen failures, or issues with data quality will be provided. The course is interactive and designed to allow for the exchange of ideas between peers in addition to learning from the instructor.

COURSE AGENDA
DAY ONE

Drug Development Process and Project Teams

Outline 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

GCP Guidelines and FDA Regulations

The Regulations
Who is responsible? Sponsor, Monitor, Investigator
How can Project Management roles help clarify responsibilities?

The Project Operating Guideline

A key document to manage expectations
How does the POG differ from a contract or a project plan?
Best Practices
Measuring Performance of the POG and related SOPs

Clinical Trials Timelines and Budgets

Generally accepted metrics
Developing an accurate timeline - key to success
Budgets, Grants, Contracts (selecting the best option)

DAY TWO

Additional Challenges with Global Trials

European Submission Procedures and its impact on timelines
What about culture, language and medical practice?
Logistics issues (import/export documentation;manufacturing issues;Qualified Person &)
How to take advantage of each country requirements to become more efficient?

Project Monitoring and Control

Establishing a reliable baseline
Selecting the right level of monitoring
Ensuring High Quality Data
Reporting Requirements

Subject Enrollment Strategy

Target, Timelines and Investigators Selection
Best Practices
How to enhance Patient Recruitment

Clinical Supplies

Manufacturing Authorization
Ordering and Labeling
Lessons Learned

Global Deliverables and Managing Adverse Events

Who needs to know what?
Study Completion Best Practices
Adverse Event Reporting (Requirements and Management Considerations)
Drugs versus Medical Devices
AEs versus Serious Adverse Events (SAEs)
Fraud and Misconduct

Summing it all up

Past Participants' Comments

"Excellent course - learned a lot, interesting examples of points. Break our sessions were really good - lots of interaction. A number of the topics I had not considered but the course presented these topics as applicable to my own business and would time/budget saving if implemented. Good ideas, excellent networking opportunity!"
Dianne W., Clinical Research Associate

"Course Director was well organized and an effective speaker. I would certainly consider taking other courses from CfPIE and this Course Director."
Danielle C., Regulatory Scientist, Merck

"It was fun, informative, and challenging. I will suggest to my peers to attend this course since it can be applied at any level of pharma."
Gard W., Consultant, Nova Safety Consulting

"Absolutely excellent! I got far more information out of this course than I anticipated! Great speaker, great content!"
Sandy H., President, Inspiring Minds Inc.

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