ECTS
120 credits
Duration
2 years
Training structure
Faculty of Pharmacy
Language(s) of instruction
French
Presentation
Training in health product safety assessment: pharmacology, toxicology, pharmacokinetics, from raw materials to finished products.
Objectives
Ensuring the quality and safety of healthcare products, particularly in the context of their non-clinical development.
Know-how and skills
- 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.
Program
Select a program
M1 Sciences of Medicine and Health Products (P3)
Core UEs
15 creditsToxicological investigation
5 creditsMolecular pharmacology and therapeutics
5 creditsAnalytical techniques for drug quality control
5 credits
Pharmacokinetics, pharmacodynamics and biopharmacy
5 creditsAdvanced analysis techniques for Medi development.
5 creditsDrug design: Introduction to drug design
5 creditsLong course
15 creditsInternship
10 creditsTER Health product development pathway
5 credits
M2 Health Product Development: Quality and Safety
Admission
Admission requirements
In M1: Bachelor's degree in Chemistry - Bachelor's degree in Life Sciences - Bachelor's degree in Health Engineering.
Applications can be submitted online:
- If you are already a student at UM or another university, you can apply via the platform. “My Master” . Don’t forget to fill out and attach the course selection form with a ranking of choices in your application.
- If you are a foreign student and would like to continue your studies in France with us, please follow the Campus France procedure. In this case, please follow the Campus France procedure.
- You are not a student (or have not been one for more than 1 year) and would like to resume your studies as a continuing education student. If so, please contact Mrs Avelli for administrative information.
M2: Diplôme d'Etat de Docteur en Pharmacie, Médecine, Odontologie, Vétérinaire.
Applications can be submitted online:
Apply: