Global Drug Safety Regulations
Expert-defined terms from the Postgraduate Certificate in Drug Safety Assessment course at UK School of Management. Free to read, free to share, paired with a globally recognised certification pathway.
Global Drug Safety Regulations #
Global Drug Safety Regulations
Global Drug Safety Regulations refer to the set of rules, laws, and guidelines e… #
These regulations govern the entire lifecycle of a drug, from preclinical testing to post-marketing surveillance. Compliance with these regulations is mandatory for pharmaceutical companies to market their products in different countries.
Adverse Drug Reaction (ADR) #
Adverse Drug Reaction (ADR)
An Adverse Drug Reaction (ADR) is a harmful or unintended response to a medicati… #
ADRs can range from mild side effects to severe complications and can occur with both prescription and over-the-counter medications.
Benefit #
Risk Assessment
Benefit #
Risk Assessment is a systematic process used in drug development and regulatory decision-making to evaluate the benefits of a drug in relation to its risks. The assessment considers the efficacy of the drug in treating a specific condition against the potential adverse effects it may cause. The goal is to ensure that the benefits of the drug outweigh its risks for patient safety.
Case Processing #
Case Processing
Case Processing involves the collection, assessment, and documentation of indivi… #
This process includes data entry, medical coding, narrative writing, and quality control to ensure accurate and timely reporting of adverse events to regulatory authorities.
Data Mining #
Data Mining
Data Mining is a method used in pharmacovigilance to explore large databases of… #
Data mining techniques help identify new or rare adverse reactions that may not have been previously recognized during clinical trials.
Expedited Reporting #
Expedited Reporting
Expedited Reporting refers to the timely submission of serious and unexpected ad… #
This reporting requirement aims to ensure rapid detection and assessment of potential safety issues with a drug to protect public health.
Good Pharmacovigilance Practices (GVP) #
Good Pharmacovigilance Practices (GVP)
Good Pharmacovigilance Practices (GVP) are a set of guidelines and standards est… #
GVP covers all aspects of pharmacovigilance, including data collection, signal detection, risk management, and communication of safety information.
ISO IDMP Standards #
ISO IDMP Standards
ISO IDMP Standards refer to the International Organization for Standardization (… #
The standards aim to improve the accuracy and consistency of product data across different regulatory jurisdictions.
MedDRA #
MedDRA
MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical… #
MedDRA facilitates the exchange of safety information between regulatory authorities, pharmaceutical companies, and healthcare professionals by providing a common language for reporting adverse events.
Pharmacovigilance #
Pharmacovigilance
Risk Management Plan (RMP) #
Risk Management Plan (RMP)
A Risk Management Plan (RMP) is a document that outlines the strategies, measure… #
RMPs are required for certain drugs with specific safety concerns and outline the risk minimization activities to ensure the safe use of the product.
Signal Detection #
Signal Detection
Signal Detection is the process of identifying potential safety signals or new i… #
Signals may indicate previously unrecognized adverse reactions, changes in the frequency or severity of known reactions, or new drug interactions that require further investigation.
Therapeutic Goods Administration (TGA) #
Therapeutic Goods Administration (TGA)
The Therapeutic Goods Administration (TGA) is the regulatory authority in Austra… #
TGA oversees the approval, monitoring, and safety of therapeutic products to ensure they meet quality, safety, and efficacy standards.
Unified Modeling Language (UML) #
Unified Modeling Language (UML)
Unified Modeling Language (UML) is a standardized visual modeling language used… #
UML diagrams, such as use case diagrams, class diagrams, and sequence diagrams, help stakeholders understand the requirements and interactions of a system.
World Health Organization (WHO) #
World Health Organization (WHO)
The World Health Organization (WHO) is a specialized agency of the United Nation… #
WHO sets global health standards, provides technical assistance, and coordinates health initiatives worldwide. WHO collaborates with member states, partners, and stakeholders to improve health outcomes and address global health challenges.