lso known as drug safety, is relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance focuses on Adverse Drug Reactions.
Information received from patients and healthcare providers via pharmacovigilance and medical literature, plays a critical role in providing the data necessary for pharmacovigilance. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by pharmaceutical company is required to be submitted to the local drug regulatory authority.
Thus, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.
Medical devices have an immensely important role in diagnosis, prevention, and treatment of different diseases. Recent strides in scientific innovation have substantially increased the role of medical devices in the health-care delivery system. There are more than a million medical devices available ranging from simple bandage or tongue depressor to complex devices such as magnetic resonance imaging machine and medical software application.
Our expert Materiovigilance team provides best post-marketing surveillance practice for medical devices compliant to
- 21CFR (803)
- EU MDR
- UK Medical Devices Agency &
- MvPI (India)
Indivirtus has a team of experts to closely monitor medical device-associated adverse events (MDAE) resulting from the use of medical devices by means of having a robust system in place which comprises identifying, collecting, reporting, and estimating undesirable occurrences and reacting to them, or safety corrective actions after their post-marketing phase.
Cosmetovigilance allows to control or rule out potentially hazardous ingredients that may be present in cosmetic products.
In the European Union (EU), cosmetovigilance was established under the Cosmetics Regulation (EC) No. 1223/2009. Stating that, “ensuring traceability of a cosmetic product throughout the whole supply chain helps to make market surveillance simpler and more efficient”.
The Responsible Person, distributors, end users or health professionals should report serious undesirable effects to the competent authority, which shall immediately transmit the information (and to the Responsible Person, if it was not reported by it). All serious undesirable effects (known and reasonably expected), the name of the cosmetic product (specific identification) and corrective measures taken (if any), need to be included in the information reported. Competent authorities may use the information for purposes of in-market surveillance, market analysis, evaluation and consumer information and can likewise request from the responsible person a list of cosmetic products that contain the substances which have raised serious doubts in terms of safety.
Veterinary pharmacovigilance (PV) is important for the Medicine which is used for treating disease in animals. The safety of medicine in animals can be assessed by veterinary PV. The research institutes involved in animal research and veterinary hospitals can be considered as ADR monitoring centres to assess the safety of medicines on animals.
As per EMA, veterinary PV concerns “monitoring, evaluating, and improving the safety of veterinary medicines, with particular reference to adverse events in animals and human beings related to the use of these medicines.” It also involves the collection of information on adverse events due to off-label use and investigations of the validity of the withdrawal period and of potential environmental problems.
ADR in animals is of major concern to the health of animals. ADRs have a direct impact on animals and indirect impact on human beings. The mortality rate of animals in India due to lack of veterinary PV is very high as compared to other developed countries. The concept of veterinary PV in India has to match that of USA, Canada, Europe, Japan, and China.