The main objective of WM Ophthalmics company is to provide patients and physicians with safe and effective medicinal products . When developing new medicinal products , efficacy and safety are evaluated when carrying out clinical trials . Nevertheless, clinical trials do not permit to evaluate completely the safety of medicinal products and to identify all the adverse reactions which may develop in the course of treatment: clinical trials are carried out in a limited number of patients, during limited time under the specially created conditions. Elderly patients, patients with concomitant diseases, pregnant and breastfeeding women, children are not enrolled in studies in most cases. Due to this, the information on long-term administration of medicinal products, drug-to-drug interaction results, peculiarities of usage in elderly people, children, pregnant women, development of rare can be obtained at the stage of clinical usage of medicinal products from the medical staff which monitors over patients in the course of treatment, and from the patients, administering this medicinal product.
Information gathering on medicinal product usage safety permits the company to obtain and furnish patients and physicians with new, reliable information on medicinal product safety; consequently, this helps physicians to make a correct prescription and to control better patients’ therapy. This permits patients to identify adverse reactions at the early development stages, and to adjust the therapy on time.
A continuous monitoring of medicinal product safety after their market launch makes an integral part of our obligations towards patients and medical staff.
is such an activity that carries out identification, evaluation and prevention of adverse events . Reports on adverse events from medical, pharmaceutical professionals and patients represent an important source of information on the safety of .
Medicinal product: A substance or a combination of some substances of natural, synthetic or biotechnological origin which possess a pharmacological activity, are used in a definite dosage form for medical prevention, diagnostics, treatment and medical rehabilitation of patients, pregnancy prevention by means of internal or external use.
Medicinal product: A substance or a combination of some substances of natural, synthetic or biotechnological origin which possess a pharmacological activity, are used in a definite dosage form for medical prevention, diagnostics, treatment and medical rehabilitation of patients, pregnancy prevention by means of internal or external use.
Clinical trial/study: Any study/trial, carried out in humans as subjects to identify or confirm clinical and/or pharmacological effects of the investigational products and/or to identify adverse reactions to investigational products, and/or to study their absorption, distribution, metabolism, and excretion to evaluate safety and/or efficacy.
Clinical trial/study: Any study/trial, carried out in humans as subjects to identify or confirm clinical and/or pharmacological effects of the investigational products and/or to identify adverse reactions to investigational products, and/or to study their absorption, distribution, metabolism, and excretion to evaluate safety and/or efficacy.
Medicinal product: A substance or a combination of some substances of natural, synthetic or biotechnological origin which possess a pharmacological activity, are used in a definite dosage form for medical prevention, diagnostics, treatment and medical rehabilitation of patients, pregnancy prevention by means of internal or external use.
Adverse reaction: An unintended adverse body reaction due to the administration of a medicinal product which assumes at least a possible relationship with the administration of a suspected medicinal product.Note – Adverse reactions may arise when a medicinal product is used in accordance with the approved package leaflet, in breach of the package leaflet or as a result of the impact, related to the profession. The cases of an off-label use include off-label use, overdoses, abuse, misuse and medical errors.
Adverse reaction: An unintended adverse body reaction due to the administration of a medicinal product which assumes at least a possible relationship with the administration of a suspected medicinal product.Note – Adverse reactions may arise when a medicinal product is used in accordance with the approved package leaflet, in breach of the package leaflet or as a result of the impact, related to the profession. The cases of an off-label use include off-label use, overdoses, abuse, misuse and medical errors.
Pharmacovigilance: An activity intended to identify, evaluate, understand and prevent unintended consequences of medicinal product administration.
Adverse event: Any untoward change in the health status of a patient or a clinical study/trial subject who was prescribed the medicinal/investigational product, irrespective of the causal relationship with its use.Note – An adverse event may represent any adverse and unintentional change (for example, a laboratory abnormality), symptom or disease, the onset time of which doesn’t exclude a causal relationship with the medicinal product use, regardless of the available or absent relationship with the medicinal product use.
Adverse event: Any untoward change in the health status of a patient or a clinical study/trial subject who was prescribed the medicinal/investigational product, irrespective of the causal relationship with its use.Note – An adverse event may represent any adverse and unintentional change (for example, a laboratory abnormality), symptom or disease, the onset time of which doesn’t exclude a causal relationship with the medicinal product use, regardless of the available or absent relationship with the medicinal product use.
Medicinal product: A substance or a combination of some substances of natural, synthetic or biotechnological origin which possess a pharmacological activity, are used in a definite dosage form for medical prevention, diagnostics, treatment and medical rehabilitation of patients, pregnancy prevention by means of internal or external use.
