Adoption Survey for PLM Portal Web-Based Electronic Application Form (eAF) Users

Adoption Survey for PLM Portal Web-Based Electronic Application Form (eAF) Users The eAF team at the European Medicines Agency (EMA) has introduced a user-adoption survey to those using the PLM Portal web-based electronic Application Form (eAF). This project is aimed at learning more about user experiences and making sure that the platform still serves the… Continue reading Adoption Survey for PLM Portal Web-Based Electronic Application Form (eAF) Users

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Categorized as Regulatory

FDA Adverse Event Monitoring System (AEMS) Electronic Submissions: Streamlining Regulatory Safety Reporting

FDA Adverse Event Monitoring System (AEMS) Electronic Submissions: Streamlining Regulatory Safety Reporting The FDA Adverse Event Monitoring System (AEMS) Electronic Submissions framework marks a transformative step in modernizing regulatory safety reporting. Replacing the former FDA Adverse Event Reporting System (FAERS), AEMS introduces a unified, centralized platform designed to improve the quality, consistency, and efficiency of… Continue reading FDA Adverse Event Monitoring System (AEMS) Electronic Submissions: Streamlining Regulatory Safety Reporting

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Categorized as eCTD

What Is Good Laboratory Practice (GLP)?

What Is Good Laboratory Practice (GLP)? In the pharmaceutical industry, ensuring the safety, quality, and reliability of laboratory data is critical before any drug reaches the market. Good Laboratory Practice (GLP) is a globally recognized quality system that governs how non-clinical laboratory studies are planned, performed, monitored, recorded, and reported.

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Categorized as Regulatory

What is the Global Substance Registration System (GSRS)?

What is the Global Substance Registration System (GSRS)? In the modern pharmaceutical landscape, where global harmonization and data accuracy are critical, the Global Substance Registration System (GSRS) has emerged as a powerful solution for substance identification and standardization.

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Categorized as Regulatory

What is a Product Information File (PIF)?

What is a Product Information File (PIF)? The pharmaceutical industry is highly controlled and in this regard, it is important to maintain the safety, quality and compliance of the products. The Product Information File (PIF) is a key component of attaining these objectives.

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Categorized as Regulatory
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