Eric Abadie's resignation as Chair of the Committee for Medicinal Products for Human Use of the European Medicines Agency shocked the industry.
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One increasingly popular way to help ease the transition into a new role in the clinical trial space is through a mentoring program.
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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FDA Draft Guidance "Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and postapproval Clinical Investigations" is reviewed.
ISR Reports
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Better selection and tougher site management is not enough to improve enrollment success.
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.
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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.
Medidata Solutions
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