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.
|EU-QPPV||Graduated Plan Officer (AMG)|
|Residence||Member State of the EU or EEA||EU Member State|
|Scope||Medical deficiencies||Medical and pharmaceutical deficiencies|
|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.