Early Stage Clinical Studies for Drugs and Devices
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This course is available as a client site course. Please click here for more information.
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.