Health Product Development: Quality and Safety

Quality assurance and safety of health products, particularly in the context of their non-clinical development.

• Know the regulatory requirements for assessing the safety of health products, from raw materials (active ingredients, impurities, residual solvents, heavy metals, polymorphism, stability, etc.) to finished products (medicines, cosmetics, medical devices, etc.).
• Know how to develop toxicological investigation protocols: understand the general aspects (choice of species, doses, evaluation of metabolites, QSAR, etc.), regulatory assessment methods (single-dose toxicity, repeated-dose toxicity, mutagenicity, carcinogenicity, reproductive toxicity, immunotoxicity, local tolerance, transdermal transfer, phototoxicity, etc.) and alternative methods.
• Knowing how to design and conduct safety pharmacology studies: regulatory aspects,core battery, complementary studies, pediatric investigation plan, alternative methods, etc.
• Understanding the principles, expected results, and limitations of pharmacokinetic studies conducted for marketing authorization applications (in silico, in vitro, in vivo), interpret pharmacokinetic data from population pharmacokinetic modeling (quantification of variability and identification of sources of variability that may impact the safety of drug administration), take into account the pharmacokinetic specificities of innovative drugs such as nanomedicines and biotherapies.