Blog
Women Participation in Clinical Trials – Conflict, Controversy and Change.
06 March 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 February 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 January 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 October 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. Who can become the QPPV? What are his key responsibilities? Does each pharmaceutical company have to employ a QPPV?
Replace, Reduce, Refine. Animal testing in drug development.
16 October 2023
Animal testing has long been a crucial aspect of drug development, aiding researchers in understanding the safety and efficacy of potential treatments. However, the ethical concerns and scientific limitations associated with animal testing have prompted the scientific community to embrace the principles of “Replace, Reduce, Refine” (3Rs) to minimize the use of animals and enhance the quality of research in this field.
From crisis to hope. Restoring mental wellness in a post-pandemic world
09 October 2023
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. It is frightening that suicide attempts among children have increased several times compared to the pre-pandemic level. Check what the results of scientific research say about how drastically the level of mental health in our society has decreased and find out how you can help yourself and your loved ones.
Medicinal products advertisement – what is it and what requirements must it fulfill?
02 August 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? Stay informed with the latest medicinal products advertisement regulations and best practices. Read now for expert insights and guidance.
Is market analysis important for pharmaceutical project success?
20 July 2023
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 turned down the idea of using it. Nowadays, even smaller brands don’t hesitate to spend money for reliable recognition of the market. Does this problem also apply to generic drugs? It may seem that the introduction of a generic drug will guarantee market success. Therefore, is there anything to be afraid of? Is there any risk, anything can go wrong?
How to increase the safety of used cosmetics? A few words about cosmetovigilance
12 July 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.
IMPD for ATMP – going into clinic
12 May 2023
Like every medicinal product, also an ATMP has to be well described prior each clinical trial. Hence, it is necessary to prepare a complete set of relevant documents required by law and then obtain approval for the clinical trial issued by the respective national agency. Explore the crucial steps of preparing an Investigational Medicinal Product Dossier (IMPD) for Advanced Therapy Medicinal Products (ATMP) as they progress into clinical trials.
Safety management of adverse reactions from clinical trials – what you need to know
13 April 2023
Safety management is key to any clinical trial and an utmost obligation to any pharmaceutical company introducing new medicinal products to the market. Whilst conducting a clinical trial, safety of all subjects is paramount, therefore best efforts should be made to capture any safety issues. All safety aspects have to be analyzed in the study protocol and approved by Competent Authorities (CAs) before any actions are taken or any subject […]
Responsibilities of the Marketing Authorisation Holder (MAH) after obtaining the Marketing Authorisation (MA) for the medicinal product in Poland
01 March 2023
As soon as the MA has been granted for the medicinal product, the Marketing Authorisation Holder (MAH) is responsible for the product’s quality, efficacy and safety. Therefore, the MAH is obliged to comply with national and European legislation. It is important to remember that depending on the country in which the medicinal product has obtained the MA, the MAH has different obligations, which must be kept […]