Pharmacovigilance: Focussed on safety – we take on your drug safety obligations.

The word Pharmacovigilance or drug safety is composed of the Greek word pharmakon, meaning “remedy” or “poison”, and the Latin vigilantia “care, vigilance”.
In practice, it entails continuous and systematic monitoring of the safety of medicinal products for humans and animals, thereby allowing risks to be minimised. This is achieved by assessing and understanding adverse effects and taking appropriate action.

Following the clinical development of a medicinal product, its continued observation and documentation of adverse events are indispensable and legally required, even after marketing authorisation has been granted. Indeed, due to the limited number of subjects in clinical trials, rare side effects and interactions can often be detected only after market launch.

In the event of a suspected side effect, immediate reporting is obligatory, even if a causal relationship between the medicinal product and the effect cannot be established beyond doubt. Unexpected adverse reactions are of particular interest for the overall evaluation of a medicinal product. Through continuous medical-scientific development, new safety-relevant findings can be determined even years after a marketing authorisation is obtained. This may mean that the authorisation status of a long-established medicinal product must be adapted to current scientific knowledge, and, if necessary, information must be provided on risks and their mitigation.

A corresponding vigilance system exists for medical devices, the establishment of which is prescribed by European medical device legislation.

Focussed on safety – we can oversee your obligations for medicinal product safety as a marketing authorisation holder.

Pharmacovigilance (PV) legislation was formalised and implemented by the EU in 2012 in order to regulate the detection, management and prevention of adverse reactions to medicines in patients. In line with these changes and to fulfil and implement the obligations of Pharmacovigilance, organisations authorised to produce a medicinal product for human use now require the services of a Qualified Person responsible for Pharmacovigilance (QPPV). Mediconomics have the expertise and approval of the European Medicines Agency (EMA) to provide your organisation with tailor-made Pharmacovigilance solutions, saving you valuable time and expense.

List of the difference of EU-QPPV vs. step-by-step plan officer according to § 63a AMG (Germany)
EU-QPPV
 Graduated Plan Officer (AMG)
Residence
 EU or EEA Member State
 EU Member State
Scope
 Medical deficiencies
 Medical and pharmaceutical deficiencies
Liability
 MAH
 Personal liability
Penalties
 No
 Yes
Backup
 Yes, backup procedure and backup person must be available.
 Desirable
Contact/Reporting
 Acts as central point of contact for competent authorities of EU member states and for inspections. 24/7 coverage necessary
 Obligation to report risks of medicinal products and to report further information at the request of the competent authority
PV-System
 Establishment and maintenance
 Establishing and maintaining as well as collecting and evaluating drug risks and coordination of necessary measures
Pharmacovigilance System Master File (PSMF)
 Safeguard that the information in the PSMF is an accurate and up-to-date reflection of the PV system.
 No

Our services include:

  • Evaluation of the current PV status
  • Literature research
  • Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)
  • Implementation of PV systems and alert plans
  • EU-conform electronic reporting (XEVPRM, ICSR),
  • Compilation of Risk Management Plans (RMPs)
  • Training, audit and more

Our Pharmacovigilance flyer is available for download.

FAQ – frequently asked questions

Pharmacovigilance includes all activities related to monitoring the safety of medicinal products with the aim of detecting adverse effects and subsequently taking measures to minimise risks.

The most essential tasks in practice are the continuous monitoring of the risks in relation to the benefits of a medicinal product after marketing authorisation and the evaluation of incoming suspected cases of adverse reactions after marketing authorisation and after market launch.

Pharmacovigilance covers drug safety, i.e. the ongoing and systematic monitoring of the safety of a drug.

This term is often also used to refer to drug safety activities in the context of clinical trials, although in the formal legal sense, these are not subject to GVP but to GCP.

Pharmacovigilance (PV) serves to manage the risks associated with the use of medicinal products, to detect production errors or defective packaging, to prevent therapeutic errors and to provide information on medicinal products. Furthermore, reporting adverse drug reactions to competent authorities is an important element of PV.

Pharmacovigilance contributes to the improvement and promotion of public health and safety with regard to the use of medicines. It also supports effective communication to the public and promotes safety, rational and (cost-)efficient use by assessing the benefits, harms, efficacy and risk of a medicinal product.
Medical devices too, are subject to vigilance procedures –formalised by the MDR- in order to address post-marketing product safety.

In the area of medical devices, too, there is – formalised by the MDR – the concept of vigilance, which addresses post-marketing product safety.

The pharmacovigilance (PV) system is defined as a system used by an organisation to fulfil its legal duties as well as its PV responsibilities. It is used to monitor the safety of medicinal products and to detect any changes in the risk-benefit balance. The overall quality objectives of a PV system are to comply with the legal requirements for PV tasks and responsibilities, to prevent harm from adverse reactions, to promote the safe and effective use of medicinal products by providing all necessary information in a timely manner, and thus to contribute to the protection of the health of patients and the public.

A sponsor or marketing authorisation holder may engage a contract research organisation (CRO) to perform pharmacovigilance tasks for the period during which a clinical trial is being conducted to test a medicinal product or also for the period after marketing authorisation and market launch.

Contract research organisations (CROs)- such as Mediconomics- are service providers in the medical field and offer professional support in the area of Pharmacovigilance (PV). For instance, CRO experts can oversee the development and maintenance of PV master data or the risk management plan, prepare safety reports, manage the legally compliant processing and submission of safety reports on individual cases in the form of ICSRs or conduct audits and training. In addition, companies can provide specialised persons who are required to have specific qualifications, such as the QPPV.

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