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Nice response to my questions and good suggestions for moving forward.

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

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Project Management for Phase l & ll Clinical Trials

Global CompliancePanel
Global CompliancePanel
Training Options
 Duration: 60 Minutes  
Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Price: $295.00
Global CompliancePanel
Global CompliancePanel
Customer Testimonials
Instructor James Harris
Product Id 600137

Overview: Before a pharmaceutical product can be approved for marketing in the United States, it must be tested clinically on human patients. Three levels of testing are defined with each level having different goals and number of patients.

This program will define the first two levels of clinical testing (designated as Phase I and Phase II) and show how the project manager for these two levels has very different duties. These duties will be identified and we will show what is required of the project manager and how to manage such trials.

Why Should You Attend:
This program is a must for project managers and directors both from CROs and the sponsor pharmaceutical manufacturers. Unfortunately, most employers of these individuals do not train their staff adequately thereby leaving them feeling lost and uncertain about what they should be doing and how to accomplish their job responsibilities. In many cases, training is left to more senior project managers who were never trained themselves. Thus, new project managers are trained by people who know only slightly more than the people being trained. The result is that training is being done by people who have found survival techniques but do not necessarily know the best techniques. This course was put together by several highly experienced senior project managers and their directors who together have defined what this job entails, how Phase I and Phase II management differ, and how to resolve problems as they arise.

Areas Covered in the Session:

  • Typical responsibilities and duties of a project manager
  • What is a Phase I trial?
  • Project management responsibilities in Phase I and how to do them
  • What is a phase II trial?
  • Project management responsibilities in Phase II and how to accomplish
  • Common pitfalls and how to resolve

Who Will Benefit:

  • VP
  • Director
  • Project Managers
  • Clinical Research Associates



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