Blog
Primum non nocere – a word about wise use of medicines and reporting adverse drug reactions
28 marca 2024
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 […]
How to divide responsibilities in a GMP-related contract? A quality agreement is the answer
18 marca 2024
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 […]
Women Participation in Clinical Trials – Conflict, Controversy and Change.
06 marca 2024
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 […]
A Brief History of the GMP
20 lutego 2024
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 […]
The changing face of clinical trials. A long and fascinating journey to effective and safe medicines.
05 stycznia 2024
In the era of numerous civilization diseases and other threats to human life and health, patients worldwide expect new therapies which are both effective and safe. However, access to modern drugs would not be possible without clinical trials, which are a necessary element of the drug marketing authorization process. Clinical trials have been a part of the medical landscape for over 275 years, creating […]
QPPV – the key player in Pharmacovigilance
25 października 2023
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 […]
Replace, Reduce, Refine. Animal testing in drug development.
16 października 2023
In order to introduce a new medicine to the market, the applicant must demonstrate that the proposed product is safe and effective. This is done by presenting the set of quality, non-clinical and clinical data obtained during the developmental studies, which are then evaluated by regulatory authorities. The volume of the data required, impacting the type and extent of studies, depends on the medicine, which is going to be registered. […]
From crisis to hope. Restoring mental wellness in a post-pandemic world
09 października 2023
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 […]
Medicinal products advertisement – what is it and what requirements must it fulfill?
02 sierpnia 2023
Nowadays it is difficult to imagine an economic entity functioning without using any form of advertisement. What about medicinal products? Do life-saving and life-enhancing products also need advertising? Do medicines which have pervaded our daily lives need to be additionally advertised? On the other hand, how do we know whether to choose company A’s medicine or company B’s medicine for a headache? The rules for advertising medicinal products are laid […]
Is market analysis important for pharmaceutical project success?
20 lipca 2023
Big pharma has the unlimited budgets, but is it true? In 2012 the medical and patient world held its breath because of Sanofi’s new product launch – Zaltrap (afibercept), a medicinal product registered for the treatment of colon cancer and its price of 9600 $/month. The price of Avastin (bevacizumab), its closest competitor, was half of its price, since Sanofi’s treatment was so expensive, oncologists […]
How to increase the safety of used cosmetics? A few words about cosmetovigilance
12 lipca 2023
Every day, a lot of people experience side effects after using cosmetics, but not everyone knows that they can report them to the responsible authorities. Why reporting adverse reactions is important and how it affects the safety of cosmetics? If you want to find out what cosmetovigilance is – we invite you to read the article. Pharmacovigilance vs cosmetovigilance – what is the difference? The term „pharmacovigilance” […]