Health Product Development: Quality and Safety

Ensuring the quality and safety of healthcare products, particularly in the context of their non-clinical development.

• Understand the regulatory requirements for assessing the safety of healthcare products, from raw materials (active ingredients, impurities, residual solvents, heavy metals, polymorphism, stability, etc.) to finished products (drugs, cosmetics, medical devices, etc.).
• Know how to draw up toxicological investigation protocols: general aspects (choice of species, doses, metabolite evaluation, QSAR, etc.), regulatory evaluation methods (toxicity by single or repeated administration, mutagenesis, carcinogenesis, reprotoxicity, immunotoxicity, local tolerance, transcutaneous passage, phototoxicity, etc.) and alternative methods.
• Know how to design and conduct safety pharmacology studies: regulatory aspects, core battery, complementary studies, pediatric investigation plan, alternative methods, etc.
• Understand the principles, expected results and limitations of pharmacokinetic studies carried out 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 likely to impact on the safety of drug administration), take into account the pharmacokinetic specificities of innovative drugs such as nanodrugs and biotherapies.