Mandate for Clinical Trials Registry Databank: Implementation of FDAAA 2007 Requirements
TBA Early $220 (before September 15th)/ Regular $255 per person.

All participants who register by September 15, 2008 will receive a FREE Starbuck's Gift Card.

Workshop location:
Crowne Plaza, Foster City
1221 Chess Drive
Foster City, CA 94404
650-570-5700
 Time:
11:30 AM-1:00 PM Luncheon

1:00-4:00 PM Presentation

4:00-4:30 PM Chocolate Dessert Finale



This half-day course has been designed to provide an overview of the NEW legislation that mandates registration of clinical trials into a registry databank.

The databank is a central resource that provides current information on clinical trials to the public, healthcare providers, and researchers. Previously, only drugs being investigated to treat serious or life threatening diseases or conditions were required to be entered into the databank. However, legislation referred to as FDAAA 2007, became effective in late 2007 and most drug and biotechnology companies will need to implement these mandates in 2008.

This timely and informative workshop is ideal for Executives, Directors, Managers, Medical Monitors, Consultants and Clinical Research Associates involved in clinical research. Individuals responsible for clinical trials at drug and device companies need to understand this NEW legislation and how it will affect relevant departments.

At the completion of this workshop the participant will be able to:

  • Describe the new legislation related to the clinical trials registry databank
  • Identify clinical trials that must be added to the databank
  • Understand the steps to comply with these new requirements

This interactive workshop includes a presentation by an experienced Regulatory Consultant, a copy of the new law, hands-on exercises, and a step-by-step guide to complying with these new requirements.

P. Kasper & Associates guarantees satisfaction with every workshop. If you are not satisfied after participating in a workshop, the cost will be refunded promptly. Cancellations will be honored with a full refund if the request is received in writing at least 5 calendar days prior to the date of the workshop. To cancel enrollment in this workshop, notifications need to be received by August 31, 2008.


Check back later for enrollment in this class.

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