Pharmacovigilance defining

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

Importantly, appropriate labeling is critical to communicating potential human risk and also when appropriate should be supported with a risk mitigation plan. As most assessments of carcinogenic risk are made on individual products, additional consideration may also be needed when patients are exposed to multiple products for treating the intended disease. The need for a prospectively defined pharmacovigilance plan is a final imperative for ensuring the availability of safe medicines [36],... 

The EMEA is an advisory body reporting directly to the European Commission. It is located at London. Its structure and responsibilities are defined by Regulation 726/2004, and these are primarily coordinating the existing resources put at its disposal by the MS for the evaluation, supervision and pharmacovigilance of medicinal products . 

While the term "signal" has been used commonly and widely in the area of pharmacovigilance for years, its definition has evolved over the past few years. Clearly defined terminology is critical to ensure clarity and consistency in communication of drug safety information to patients, prescribers, manufacturers, and regulators [6], and therefore, establishing a common and clear definition of a safety signal is essential. 

Pharmacovigilance has been defined by the WHO as The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. There are other definitions but this very broad one seems to be the most appropriate since there is a clear implication that the process is one of risk management. This is a concept which is applicable to many... 

The ultimate purpose of pharmacovigilance is to minimise, in practice, the potential for harm that is associated with all active medicines. Although data about all types of ADRs are collected, the main focus is on identifying and preventing those which are defined to be serious. This means an ADR which meets at least one of the following criteria ... 

Safety may be defined as relative absence of harm. When using the word safety we often mean something else. For example, safety data often means collection of reports of harm. Safety departments in the pharmaceutical industry are generally focused much more on harm than safety. And yet how safe something is a key question for the user and one that pharmacovigilance is... 

Unexpected differences between groups of patients These possible changes necessitate monitoring pharmacovigilance. Pharmacovigilance has been defined by the... 

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