Non-Clinical Working Party (NcWP) is a dedicated group of European experts who operate under the umbrella of the Committee for Medicinal Products for Human Use (CHMP). The NcWP’s long-term goals include providing product-related support when requested by the Scientific Advice Working Party and by EMA Committees, guideline development, international support, stakeholder engagement as well as education and training.
One of the NcWP’s short-term objectives is to facilitate access to and knowledge of in silico/QSAR (Quantitative Structure-Activity Relationship) applications for the assessment of mutagenic impurities, notably nitrosamines.
We are proud to announce that Jana Brajdih Čendak from BPE, who is a member of Medicines for Europe, will provide valuable insights into the safety evaluation of specific medications using advanced techniques at the upcoming Stakeholder Meeting with NcWP, scheduled for October 3rd 2023.
The title of her presentation is Toxicological evaluation of n-nitroso derivatives of beta-blockers using in vitro and in silico data. During the session, Ms. Čendak will elaborate on the complexities of toxicological evaluation, offering valuable insights that align with NcWP’s commitment to harmonizing pharmaceutical safety in Europe.