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Editorial Archive

FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis

FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis An FDA regulatory inspection is an activity of verification. It serves to give …

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Editorial Archive

Risk Mitigation and Due Diligence in Overcoming Lost to Follow-up [LTFU] Subjects in a Clinical Trial

Risk Mitigation and Due Diligence in Overcoming Lost to Follow-up [LTFU] Subjects in a Clinical Trial The term ‘lost to follow-up’ describes a patient who …

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Editorial Archive

Enhancement of Regulatory Procedures on Medicinal Products in Serbia – Patients Information Requirements

Enhancement of Regulatory Procedures on Medicinal Products in Serbia – Patients Information Requirements Providing reliable information on medicinal products to professionals and the general public …

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Editorial Archive

Health Economics and Multinational Randomised Controlled Trials

Health Economics and Multinational Randomised Controlled Trials Collecting clinical efficacy and safety data in multinational randomised controlled trials (MNRCTs) has long been a means to achieve …

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