Blog
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 […]
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 […]
Clinical trials – where to conduct them?
01 February 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 no easy and straightforward answer as there are no formal limits in choosing the country. In this article we would like to […]
Skin products – What’s new in the ICH Q3D Guideline For Elemental Impurities?
18 January 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 the European Medicines Agency’s (EMA). It was published on 2 May 2022 and came into force on 24 September […]
Pharmacovigilance system provider
06 December 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 monitor post-authorisation safety of medicines to gather all safety data from a large number of various patients with numerous conditions and concomitant therapies using the drug for a […]
TOP 10 challenges in Market Access of ATMPs
25 November 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 official definitions regarding Market Access, let’s go through the subject of MA on the example of Advanced Therapy Medicinal Products (ATMPs). Quite challenging? Probably […]
Unstoppable changes in pharmacovigilance of veterinary medicinal products
04 November 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 medicinal products. Marketing Authorisation Holders (MAHs) will now face new challenges with regard to fulfilling legal obligations and maintaining their pharmacovigilance system up-to-date. Below provided summary gives […]
What is EudraVigilance?
31 August 2022
EudraVigilance: basic information EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is a system designed for reporting suspected adverse reactions to medicines, otherwise known as adverse drug reactions (ADRs). It has been in operation since December 2001. The European Medicines Agency (EMA) is responsible for developing, maintaining and coordinating the database. EudraVigilance supports the safe and […]
A History of Pharmacovigilance
10 August 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 expectancy increased and there was a significant drop in infant mortality. Moreover, humanity emerged victorious in the battle with numerous diseases which had […]
Risk Management Plan for EU and EAEU markets – comparison
20 July 2022
One of the documents that is needed to be prepared when registering medicinal product is Risk Management Plan (RMP). It is an obligatory document for each newly registered medicinal product. Its aim is, on the one hand, to characterize the safety profile of a given drug and, on the other hand, to broaden the knowledge […]