A Latin sentence says: anceps remedium melius quam nullum – an uncertain medicine is better than none. Have you ever wondered why the use of drugs in some populations of patients (such as pregnant women or children) is especially encouraged to be reported? The answer to this question is straightforward – it is impossible to carry out a clinical trial in every population of patients. Due to this, we do not have enough data to introduce indications in the product information for these groups of patients. But still, we need to bear in mind that those patients need and deserve effective and safe p ..read more

Lily of the Valley Day – the eternal question of dose in determining toxicology and therapeutic effect On May 1st some of us celebrate Lily of the Valley Day. This holiday is popular especially in France, known as La Fête du Muguet. On this day, the French give bouquets of lilies of the valley to each other. Lily of the valley, Latin name Convallaria majalis, is a plant with small white flowers and a strong scent. All parts of the plant are toxic, with children being particularly susceptible to poisoning. Fatal poisonings in children have been described repeatedly after eating a few berries or ..read more

Lily of the Valley Day – the eternal question of dose in determining toxicology and therapeutic effect On May 1st some of us celebrate Lily of the Valley Day. This holiday is popular especially in France, known as La Fête du Muguet. On this day, the French give bouquets of lilies of the valley to each other. Lily of the valley, Latin name Convallaria majalis, is a plant with small white flowers and a strong scent. All parts of the plant are toxic, with children being particularly susceptible to poisoning. Fatal poisonings in children have been described repeatedly after eating a few berries or ..read more

Since the prehistoric times people have used medications, primary in form of medicinal plants. Palaeolithic humans built on and expanded their knowledge on active substances present in herbal plants [1]. Just as knowledge about possible treatments has evolved over time, so has increased the awareness of drug safety and possible adverse drug reactions that might occur. Patients should be broadly educated how to use drugs in a safe and efficient manner, how to store medicines so that they do not change their beneficial properties and if any adverse reaction occurs why and where to report it. In ..read more

For any company operating in the pharmaceutical sector and involved in manufacturing and/ or importing human and veterinary medicines, the Good Manufacturing Practice (GMP) is the closest thing to a holy book in the industry. It ensures that products are consistently produced and controlled according to quality standards, minimizing the risks involved in any pharmaceutical production. As such, it is essential for any company in the sector to adhere to GMP guidelines to guarantee the safety, efficacy, and quality of their products. The European Union GMP guidelines refer several times to a term ..read more

For any company operating in the pharmaceutical sector and involved in manufacturing and/ or importing human and veterinary medicines, the Good Manufacturing Practice (GMP) is the closest thing to a holy book in the industry. It ensures that products are consistently produced and controlled according to quality standards, minimizing the risks involved in any pharmaceutical production. As such, it is essential for any company in the sector to adhere to GMP guidelines to guarantee the safety, efficacy, and quality of their products. The European Union GMP guidelines refer several times to a term ..read more

Routinely, drug development studies are conducted using animals and in clinical trials with the participation of human beings. Both of them include two subgroups: the male and female. It is known that there are many differences between the two entities in several aspects including genes, hormones, anatomy, physiology, the interactions between the genes and the whole body, their lifestyle, environment and behavior. That means clinical research which takes into consideration these differences as well as equitable representation by sex (referring to biological traits) and gender (referring to sel ..read more

Nowadays in the pharmaceutical industry the rules of Good Manufacturing Practice are something obvious. Quality manufacturing systems and the safety of the medicines are a priority for drug product manufacturers. However, it should be stated that the beginnings of GMP were developed on a number of tragedies. How the FDA pioneered the development of GMP? During the XX century, when the first medicines were released to the market the pharmaceutical industry started to develop dynamically. Initially, although it is hard to believe, there was no scrutiny of how medicines were produced. No attent ..read more

The catalysts for deterioration: mental health puzzles The events of recent years have left a deep mark on our psyche. The safety measures taken to stop the pandemic in the years 2020-2021 have had a significant impact on our lives. Society had to confront lifestyle changes, uncertainty about the future, conflicts, domestic violence, and relationship breakups. This included job loss, difficulties finding new employment, prolonged financial constraints, property sales, and getting into debt. This was the reason for a significant deterioration of mental health, manifested by depressed mood, stre ..read more

QPPV – this mysterious abbreviation identifies the most crucial person involved in the whole process of monitoring of safety of drug products, that is pharmacovigilance. The Qualified Person Responsible for Pharmacovigilance (QPPV) is responsible for the creation and management of the whole system ensuring the safe use of medicinal products both in humans and animals. In this article, we would like to describe in scratch the role and responsibilities of the QPPV. Who can become the QPPV? According to European legislation QPPV shall be: a natural person, adequately qualified, at permanent and ..read more