Continuous search for innovative solutions

The main goal of ROTAPHARM is to provide patients and physicians with safe and effective [tooltips keyword=”medicinal products (MPs)” content=”Medicinal product (MP): A substance or a combination of several substances of natural, synthetic or biotechnological origin that have pharmacological activity and, in a specific dosage form, are used for medical prevention, diagnosis, treatment and medical rehabilitation of patients, and for the prevention of pregnancy through internal or external use.”].

When developing new medicines ([tooltips keyword=”MPs” content=”Medicinal product (MP): A substance or a combination of several substances of natural, synthetic or biotechnological origin that have pharmacological activity and, in a specific dosage form, are used for medical prevention, diagnosis, treatment and medical rehabilitation of patients, and for the prevention of pregnancy through internal or external use.”]), their efficacy and safety are assessed in the course of [tooltips keyword=”clinical trials (CTs)” content=”Clinical trial/study (CT): Any study conducted with the participation of a human being as a subject in order to discover or confirm the clinical and/or pharmacological effects of investigational products and/or to identify adverse reactions to investigational products, and/or to study their absorption, distribution, metabolism and excretion with the objective of evaluating their safety and/or efficacy.”].

Nevertheless, [tooltips keyword=”clinical trials (CTs)” content=”Clinical trial/study (CT): Any study conducted with the participation of a human being as a subject in order to discover or confirm the clinical and/or pharmacological effects of investigational products and/or to identify adverse reactions to investigational products, and/or to study their absorption, distribution, metabolism and excretion with the objective of evaluating their safety and/or efficacy.”] do not make it possible to fully assess the safety of [tooltips keyword=”medicinal products (MPs)” content=”Medicinal product (MP): A substance or a combination of several substances of natural, synthetic or biotechnological origin that have pharmacological activity and, in a specific dosage form, are used for medical prevention, diagnosis, treatment and medical rehabilitation of patients, and for the prevention of pregnancy through internal or external use.”] and to identify all [tooltips keyword=”adverse reactions (ARs)” content=”Adverse reaction (AR): An unintended harmful reaction of the body associated with the use of a medicinal product and implying at least a possible causal relationship with the use of the suspected medicinal product.”], which may develop in the course of treatment: clinical trials are conducted in a limited number of patients, for a limited period of time and under specially created conditions. Elderly patients, patients with comorbidities, pregnant and breastfeeding women, and children are most often not included in studies. In this regard, information on the long-term use of medicinal products, the results of interactions with other medicines, special aspects of use in elderly people, children and pregnant women, and the development of rare [tooltips keyword=”adverse reactions” content=”Adverse reaction (AR): An unintended harmful reaction of the body associated with the use of a medicinal product and implying at least a possible causal relationship with the use of the suspected medicinal product.”] can be obtained at the stage of clinical use of medicinal products from healthcare professionals who observe patients during treatment and from patients who use this medicinal product.

The collection of information on the safety of medicine use enables the company to obtain and provide patients and physicians with new and reliable data on the safety of medicinal products, which in turn helps physicians to prescribe appropriately and to better control the treatment of patients. For patients, this makes it possible to identify the development of adverse reactions at an early stage and to adjust treatment in a timely manner.

The identification, assessment and prevention of the development of [tooltips keyword=”adverse events (AEs)” content=”Adverse event (AE): Any unfavorable change in the health status of a patient or clinical trial subject who has been given a medicinal/investigational product, regardless of a causal relationship with its use.”] associated with the use of medicinal products is carried out through such an activity as [tooltips keyword=”pharmacovigilance” content=”Pharmacovigilance: An activity aimed at identifying, assessing, understanding and preventing adverse effects associated with the use of medicinal products.”].

[tooltips keyword=”Reports” content=”Spontaneous report: The voluntary submission of data by a healthcare professional or consumer to a competent authority, a marketing authorization holder or another authorized organization (for example, the World Health Organization, regional pharmacovigilance centers, toxicology centers) containing a description of one or more adverse reactions in a patient who has taken one or more medicinal products, and which were not obtained in the course of a clinical trial or any other method of organized data collection.”] on adverse events from medical and pharmaceutical professionals and patients are an important source of information on the safety of [tooltips keyword=”medicinal products” content=”Medicinal product (MP): A substance or a combination of several substances of natural, synthetic or biotechnological origin that have pharmacological activity and, in a specific dosage form, are used for medical prevention, diagnosis, treatment and medical rehabilitation of patients, and for the prevention of pregnancy through internal or external use.”].