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.
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 of medicinal products.
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 does not only help safeguard patients but also keeps companies in regulatory and market appeals.
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
Pharmacovigilance plays a crucial role in safeguarding public health. However, as data flows through systems like EudraVigilance, protecting personal data becomes equally essential.
