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.
View Course Agenda
Past Participant's 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.
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