The Center for Professional Advancement, Amsterdam
5-6 November 2007
Who Should Attend:
This course will benefit those in the pharmaceutical, medical device and biologics industries especially:Personnel in development and clinical evaluation
Scientists who have specialized in other areas and wish to master the basics of the regulatory and technical requirements and challenges involved in clinical development
Regulatory and managerial personnel involved with planning project management and creation of development and regulatory strategies
Personnel with limited development experience
Newly hired employees of established companies whose responsibilities include new products evaluated in humans
Description:
This two-day course will give a comprehensive overview of the regulatory requirements, design, conduct and analysis of FIM (first in man) studies of new drugs, biologics and medical devices in human beings. The participant will come away knowing what must be done and what cannot be done for and in such studies and how these fit into the development process.
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