Conférences  >  Chimie  >  Biochimie et chimie médicale, toxicologie  >  République tchèque

Planned topics include new developments of computational approaches in biochemistry and biophysics, applications of quantum chemical methods on molecular models, modeling interaction in molecular materials, modeling new molecular materials, drug design molecular dynamics, Monte Carlo and molecular mechanics simulations in biodisciplines.

Uventia Global

Highly potent active pharmaceutical ingredients, or HPAPIs, are potent compounds that could effectively treat serious and life-threatening diseases such as cancer. Because of their high potency, these substances eventually put the workers in the production facility at risk. While exceptional product quality is required, additional measures must be taken to ensure operator safety. At our online meeting, leading figures from the industry, occupational toxicologists and containment specialists will review the most recent developments affecting the handling of HPAPIs. The discussion will center on the safe and effective processing of potent APIs, process development and scale-up, occupational health hazards, toxicological assessment, improvements in isolators and facilities to minimize exposure risk, containment and cleaning validation practices, and risk management for cross-contamination.

Email.: yuliia.terletska@uventia.com

HPAPI, API, Compounds Manufacturing, Occupational Toxicology, Industrial Hygiene, Process Engineering, Process Development, Containment, Cross Contamination, Cleaning Validation, Cleanroom, Risk Management, Quality Assurance, Quality Control, Analytical Development, Analytical Methods, Outsourcing

Biotechnologie,    Pharmacologie et développement des médicaments

Uventia Global

The safety, quality and clinical results of drug substances and drug products may be disrupted by the formation of nitrosamines along with other mutagenic impurities. The comprehensive development and production of innovative medicines now inevitably involves estimating impurity profiles as well as managing and monitoring them. To meet the demands of ever-increasing regulatory standards and avoid expensive recalls, proactive detection of genotoxic contaminants should be adopted at every stage of pharmaceutical development. We plan an online meeting with subject-matter experts to evaluate multiple perspectives on how to handle the concerns of mutagenic impurities. We will cover regulatory-compliant drug impurity profiling practices; helpful hints for adhering to recent ICH M7 and Q3D updates; nitrosamine impurity identification and quantification; risk evaluation of genotoxic impurities; analytical challenges and genotoxicity prediction; establishment of acceptance criteria; and the most recent developments in the analysis of elemental impurities. Save a seat at our webinar to find out about most effective methods for genotoxic and other mutagenic impurity management.

Email.: yuliia.terletska@uventia.com

Genotoxic, Impurities, GTIs, Genotoxins, Genotoxicity, Mutagenicity, Genetic, Toxicology, Chemical Toxicology, Analytical Chemistry