Pharma / Biotech
Efficient and effective management of clinical trials can significantly impact the time, scope and budget for the development of a drug. Project managers must understand the development process and the key aspects of all phases of Clinical Development 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 to achieving proof of concept for any new drug. Phase 3 clinical trials are critical to gain regulatory approval for the market and Phase 4 allows expansion and extension of the indication for a drug. 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.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
This course is an overview designed for those in the Pharmaceutical and Biotech 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:
Drug Development and Project Management
Overview of Clinical Phases – What are they?
Clinical Development Tools
Regulations Governing Clinical Research
Regulations Governing Clinical Research (cont'd)
Ethics and Warning Letters
Life Cycle Management
The course provides a thorough understanding of the activities involved during all Clinical Phase 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:
"The Course Director is highly knowledgeable and very skilled in teaching and getting all participants involved. The course is illustrated with many practical anecdotes of real life experiences in the pharma world. The course also includes exercises that are very instructive. This three day course was really worthwhile." Hamidou T., Project Manager, SMB
"The course was exceedingly useful because of the interpersonal relationship of projects we have been involved with. I would recommend this course to others. It provides the "language" (the proper lingo) to articulate the management of clinical studies." Barrie T., President, American River Nutrition
"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.
Not necessarily. It could be viewed as a refresher. A wide variety of topics are covered, from managing time, scope and budget of a trial to the regulations for trials in the US, EU and Japan as well as team skills to manage staff involved in your trial. Every company manages studies differently, so there is a great deal to learn from participants as well as the instructor.
Although the process of approval for new animal drugs is similar to human, there are enough differences that this course may not be useful if someone is involved only with veterinary products.
The clinical trial management information is not specific for any therapeutic are, but can be utilized for all areas, in general. Some of the case studies and break-out sessions focus on a specific therapeutic area, but only for learning purposes.
No, device studies are not covered in detail, just in passing.
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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