EN PL

News

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 ...

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 ...

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 ...

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 ...

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, ...

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 ...

Risk Management Plan for EU and EAEU markets – comparison

20.07.2022
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 ...

Variation - how to successfully update your dossier

13.06.2022
Have you been granted the Marketing Authorisation (MA) for your medicinal product? Are you about to release it into the market? That is for sure very positive information! Do you think it is over ...

Borderline products: drug or device? Line of demarcation drawn by new MDCG guidance

31.05.2022
Medical device regulation 2017/745 (MDR) entered into full application on May 26, 2021, but still a lot of uncertainty is associated with its implementation. So far, over 70 guidance documents ...

Clinical Evaluation Report - grounds for clinical evaluation of medical devices

25.05.2022
Clinical Evaluation Report (CER) constitutes a significant part of technical documentation (TD) that summarizes and draws conclusions on the clinical evaluation of the medical device (MD). The ...