Health Product Development: Quality and Safety

Quality assurance and safety of health products, particularly during their nonclinical development.

• Understand the regulatory requirements for the safety assessment of health products, from raw materials (active ingredients, impurities, residual solvents, heavy metals, polymorphism, stability, etc.) to finished products (drugs, cosmetics, medical devices, etc.).
• Be able 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, transcutaneous absorption, phototoxicity, etc.), and alternative methods.
• Know how to design and conduct safety pharmacology studies: regulatory aspects,“Core Battery,” supplementary studies, pediatric investigation plans, alternative methods, etc.
• Understand the principles, expected results, and limitations of pharmacokinetic studies conducted for marketing authorization applications (in silico, in vitro, in vivo), interpret pharmacokinetic data derived from population pharmacokinetic modeling (quantification of variability and identification of sources of variability that may impact the safety of drug administration), and take into account the pharmacokinetic characteristics of innovative drugs such as nanomedicines and biotherapeutics