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Sunday, February 14, 2021

Data Governance and Data Integrity (DI)

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Introduction: Data governance and data integrity (DI) are important elements in ensuring the reliability of data and information obtained ...
Sunday, December 27, 2020

Line Clearance in Pharmaceuticals

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  Line Clearance What is Line Clearance : Line clearance is a process that provides a high degree of confidence or assurance that the sa...
Wednesday, November 4, 2020

Information Requests and Discipline Review Letters of US FDA

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·          The Generic Drug User Fee Amendments of 2017 (GDUFA II) was signed into law on August 18, 2017 in order to facilitate timely acce...
Tuesday, November 3, 2020

FDA approves first treatment for COVID-19

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  The U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of...
Sunday, July 19, 2020

Different Types of Training in Pharmaceutical Industries

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Training plays an important role in any industry and it gives a clear understanding about the roles and responsibilities of a person worki...
Tuesday, June 23, 2020

Comparison of EU and US variation requirements

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  Key points in regulatory management of variations • Lifecycle management of pharmaceutical products varies between the EU and U...
Sunday, June 21, 2020

European (EU) Variation Requirements

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What is Variation: Variation means any amendment to the terms of the decision granting the marketing authorization as well as any chang...