Medsafe
The new article describes in detail the application process to be followed by the interested parties when applying for authorisations in the context of clinical trials.
Medsafe
The new article explains the requirements pertaining to notifications for clinical trials, as well as the Good Clinical Practice requirements.
Medsafe
The new article clarifies the regulatory requirements related to record-keeping and reporting in the context of clinical trials.
BfArM
The new article highlights the aspects related to the timeframes the applicants should follow.
BfArM
The new article highlights the aspects related to the timeframes the applicants should follow.
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
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