At the DIA EuroMeeting in March a look at Health Technology Assessment (HTA) alongside regulatory authority initiatives was presented.
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FDA Draft Guidance "Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and postapproval Clinical Investigations" is reviewed.
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Better selection and tougher site management is not enough to improve enrollment success.
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Industry news focusing on the people and organizations who work in the clinical trials profession.
A job seeker's two most used tools are the cover letter and resume.
The EMA issued seven draft guidances of the 16 modules for good pharmacovigilance practice in February. There has been confusion and concern among sponsors over how to implement a legislation with no clear guidance from the EMA.
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