News
IMPD for ATMP – going into clinic
12.05.2023
In recent years, a new class of medical products, named Advanced Therapy Medicinal Products (ATMPs), consisting of cellular or genetic components has quickly moved from Research and Development
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Safety management of adverse reactions from clinical trials – what you need to know
13.04.2023
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
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Responsibilities of the Marketing Authorisation Holder (MAH) after obtaining the Marketing Authorisation (MA) for the medicinal product in Poland
01.03.2023
As soon as the MA has been granted for the medicinal product, the MAH is responsible for the product's quality, efficacy and safety. Therefore, the MAH is obliged to comply with national and
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Clinical trials – where to conduct them?
01.02.2023
Each drug developer at some point reaches the moment when it is necessary to run a clinical trial, and has to ask themselves where to test the developed medicinal product. However, there is
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Skin products - What’s new in the ICH Q3D Guideline For Elemental Impurities?
18.01.2023
Have you heard about the new version of the ICH Q3D Guideline for Elemental Impurities? Do you know, it was adopted on 24 March 2022 by The Committee for Medicinal Products for Human Use (CHMP) of
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Pharmacovigilance system provider
06.12.2022
Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. It is essential to
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TOP 10 challenges in Market Access of ATMPs
25.11.2022
The Market Access (MA) topic is fascinating in itself, but like any topic, it will be more easily remembered and assimilated if it is described in a non-standard way. Instead of using
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Unstoppable changes in pharmacovigilance of veterinary medicinal products
04.11.2022
are you ready for the new regulations?
At the beginning of year 2022 Veterinary Regulation 2019/06 has come into force, introducing innovative approach to safety surveillance of veterinary
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What is EudraVigilance?
31.08.2022
EudraVigilance: basic information
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is a system designed for reporting suspected adverse reactions to medicines,
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A History of Pharmacovigilance
10.08.2022
What is pharmacovigilance and what led to its establishment?
The second half of the twentieth century was marked by the dynamic development of medicine. Hand in hand with that, the average life
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