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How genetic tests are revolutionising clinical trials

14 August 2025

One of the most significant advantages of genetic testing in clinical trials is its ability to identify patients who are most likely to benefit from a given therapy. However, the benefit is not only for patients, but also for the sponsor of the study, as the more precise recruitment increases the chances for desirable test results. By analysing a participant’s DNA, researchers can pinpoint specific genetic mutations […]

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Centralised procedure – the European Union-wide procedure for the authorisation of medicines

30 June 2025

Registration of medicinal products is a key process that ensures that all medicines distributed and sold in the European Union (EU) meet established quality, safety and efficacy standards. Therefore, regulatory systems across the EU have been carefully designed to thoroughly evaluate medicinal products before granting marketing authorisation (MA). Applicants can use several ways to obtain EU MA: the national procedure, the […]

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Pharmacological Photosensitivity: Dual Impact of UV Radiation on Skin and Drugs

17 June 2025

As temperature rises and sunny days become more frequent, many people take advantage of the longer daylight hours to spend more time outdoors. Whether it’s a walk in the park, a weekend at the beach, or simply running errands in the sun, it’s important to recognise that certain medications can significantly increase the skin’s sensitivity to ultraviolet (UV) radiation. This often-overlooked side effect, known as drug-induced photosensitivity […]

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Getting a Handle on the Pharma World: Why Market Research and Planning Are Key

16 April 2025

Getting a Handle on the Pharma World: Why Market Research and Planning Are Key Let’s face it: the pharmaceutical industry is a constantly shifting landscape. If you want to make a real impact and succeed, just having great drugs and following the rules isn’t enough. You’ve got to get the market and have a smart marketing plan in place. When you have solid market insights, […]

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World Backup Day – Regulatory Requirements and Best Practices

20 March 2025

On March 31st, we celebrate World Backup Day. It’s a perfect opportunity to remind you about one of the key issues in data security, particularly in the pharmaceutical industry. With the ongoing digital transformation that enables more effective management of documentation and processes, data protection becomes a crucial element in ensuring regulatory compliance and business continuity. Why does your company need backups? Compliance with regulatory […]

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Illustration of a nanoparticle with a size scale showing it ranges from 1 to 100 nanometers. The image emphasizes the tiny scale of nanoparticles, highlighting their potential use in drug delivery, regenerative medicine, and medical therapies.
Exploring the potential of Nanoparticles and Nanotechnology systems in medicinal products development and registration

18 February 2025

Have any of you used them? Had a contact with them? Nanoparticles are everywhere around us. Undetectable by the human eye, nanoparticles can exhibit significantly different physical and chemical properties to their larger counterparts. Researchers realized the importance of nanoparticles when they found that size can significantly influence the physiochemical properties of such substances.  Although, currently, there is a coexistence of different definitions of nanomaterials […]

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AI-Enabled Medical Devices – EU’s New Regulatory Landscape

13 January 2025

The Growing Role of AI in Digital Health Artificial Intelligence has evolved significantly since Christopher Strachey developed the first AI program in 1951 (Alowais 2023). In its early stages, AI was mainly a subject of academic study. The field took a major step forward in 1956 when John McCarthy hosted the Dartmouth Conference and introduced the term “Artificial Intelligence”. Today, AI is defined as the […]

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What’s the deal with vitamin D?

18 November 2024

What is vitamin D? Vitamin D is a series of organic chemical compounds, the most important of which are cholecalciferol (vitamin D3) and ergocalciferol (vitamin D2). They differ chemically only in their side-chain structures, but both play the same role in the body. Both vitamin D3 and D2 are inactive, and only in the body are they transformed into biologically active forms: calcitriol […]

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November 14 - World Diabetes Day, featuring medical products for diabetes management
Diabetes transforms lifestyles – medical devices transform diabetes

12 November 2024

On the 14th of November, we celebrate World Diabetes Day, commemorating the birthday of Frederick Banting, co-discoverer of insulin. Millions of people with diabetes face daily challenges. Controlling blood sugar daily requires being resilient, organized, and responsible, which impacts both the physical and mental well-being of people who have diabetes. It is incredibly demanding for children and their parents and requires daily cooperation. Fortunately, […]

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Regulations for psychotropic medications in Poland

09 October 2024

According to Article 41 of Polish Act of 29 July 2005 on Counteracting Drug Addiction, retail trade in psychotropic substances and precursors that are medicinal products shall be conducted by pharmacies, ensuring appropriate storage conditions preventing unauthorised access to these drugs and substances. Additionally, it should be noted that medications containing psychotropic substances shall be dispensed from the pharmacy only on the basis of a specially labelled prescription or requisition […]

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Pharmaceutical forms of medicines: from classic to modern solutions

20 September 2024

World Pharmacist Day provides an excellent opportunity to explore the variety of pharmaceutical forms of medicinal products that play a key role in the daily lives of millions of patients around the world. Modern pharmacy is not limited to pills and syrups – it also encompasses modern technologies and innovative solutions that are transforming the landscape of treatment forms. The choice of whether a drug is enclosed in a capsule or administered in liquid […]

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Supply chain optimization for medicinal product safety

22 August 2024

In the summer period, as temperatures rise, ensuring the safety of medicinal products becomes important. High temperatures may significantly affect product quality, leading to serious consequences for patient safety and regulatory compliance. Therefore, the optimization of the cold chain supply is a key element of the strategy for every pharmaceutical company. This article discusses the importance of cold chain management in the pharmaceutical supply chain, […]

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