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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
Korea, South

Legislations

  1. Pharmaceutical Affairs Act (No. 91235) Articles 10 and 31-34 (2008)
  2. Act on the Protection of Personal Information Maintained by Public Agencies No. 8871 (2008)


Regulations

  1. Enforcement Rule of Pharmaceutical Affairs Act Articles 22, 31-34


Guidelines

  1. Korean Good Clinical Practice Public Notification of Food and Drug Administration, No. 2007-4 (2007)
  2. Guideline for Investigational New Drug Application: Public Notification No. 2004-51 (2004)
  		 


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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