What Is Drug Master File (DMF) Submission? Drug Master File (DMF) submission is a classified document that is submitted to the U.S. Food and Drug Administration (FDA) and entails detailed data regarding the manufacturing, processing, packaging or storage of the components employed in the pharmaceutical drug products.
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ICSR Management: Ensuring Patient Safety Through Effective Case Handling
ICSR Management: Ensuring Patient Safety Through Effective Case Handling In pharmacovigilance, adverse drug reaction (ADR) report gathering and analysis is critical to the overall protection of the health of the population. Another essential part of this initiative is the Individual Case Safety Report (ICSR) a harmonic framework of storing and reporting the suspected adverse reactions… Continue reading ICSR Management: Ensuring Patient Safety Through Effective Case Handling
Pharmacovigilance Risk Management : Protecting Patient Safety Through Proactive Strategies
Pharmacovigilance Risk Management: Protecting Patient Safety Through Proactive Strategies Pharmacovigilance is a crucial science, which secures the unnecessary safety of drugs, once they enter the market. At the core of this is risk management, which is a preventive exercise that aids in identifying, analyzing, and reducing the risk involved in pharmaceutical products. Proper risk management… Continue reading Pharmacovigilance Risk Management : Protecting Patient Safety Through Proactive Strategies
Signal Management in Pharmacovigilance: Detecting and Acting on Safety Concerns
Signal Management in Pharmacovigilance: Detecting and Acting on Safety Concerns Signal management in pharmacovigilance is a key process that facilitates safety of the patient by detecting, assessing, and controlling possible safety concerns of medicinal products. Signals are have information implying a new or modified bad event that potentially must be studied or regulated.
GVP Module VI Addendum II: Masking Personal Data in ICSRs – A Vital Step Toward Privacy
GVP Module VI Addendum II: Masking Personal Data in ICSRs – A Vital Step Toward Privacy Pharmacovigilance plays a crucial role in safeguarding public health. However, as data flows through systems like EudraVigilance, protecting personal data becomes equally essential.
What is Aggregate Reporting
Aggregate Reporting in Pharmacovigilance: A Critical Compliance Requirement A legal and ethical duty of pharmaceutical companies is safety monitoring of their products during the lifecycle; the drug development and post-marketing. As Individual Case Safety Reports (ICSRs) only involve recording individual adverse events, the focus is received on a bigger picture with aggregate reporting.
What is Computer System Validation (CSV)
In today’s fast-evolving digital landscape, businesses increasingly rely on complex computer systems to manage critical operations, especially in regulated sectors like pharmaceuticals, biotechnology, medical devices, and manufacturing.
What is Regulatory Artwork
Regulatory artwork is crucial in the highly regulated industry of product manufacturing and distribution, and this is relevant especially in making the products comply with the legal requirements and make them available to consumers in time.
Implementation of The European Pharmacopoeia Supplement 12.1
Implementation of The European Pharmacopoeia Supplement 12.1 Publication schedule: Issue Publication date Correction date Implementation date 12.1 07/2025 31/08/2025 01/01/2026 12.2 10/2025 30/11/2025 01/04/2026 12.3 01/2026 28/02/2026 01/07/2026
What is Regulatory Labeling
In today’s global marketplace, regulatory labeling is vital for product compliance, consumer safety, and corporate success. Regulatory labeling refers to the necessary information that manufacturers must show on their products or packaging in order to meet legal requirements established by government authorities and international organizations.