Health

Health Product Development: Quality and Safety

  • 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.

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Objectives

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

 

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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.
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Program

Select a program

M1 Pharmaceutical Sciences and Health Products

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M2 Health Product Development: Quality and Safety

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  • Development of high-risk pharmaceutical forms

    4.5 credits
  • Toxicology: specific and cross-sectional study methods

    4 credits
  • Safety pharmacology

    4 credits
  • Specific courses

    • Development of high-risk pharmaceutical forms

      4.5 credits
    • Toxicology: specific and cross-sectional study methods

      4 credits
    • Safety pharmacology

      4 credits
    • Prediction of pharmacokinetic properties

      3 credits
      • Prediction of CT pharmacokinetics

      • Prediction of CC pharmacokinetic properties

    • Raw materials and macromolecules for new therapies

      4.5 credits
  • Prediction of pharmacokinetic properties

    3 credits
    • Prediction of CT pharmacokinetics

    • Prediction of CC pharmacokinetic properties

  • Raw materials and macromolecules for new therapies

    4.5 credits
  • Core syllabus

    • News and recent advances in drug science

      4 credits
    • Comnunication - Application of English

      3 credits
    • Project and risk management

  • Tutored project Health product development pathway

    10 credits
    • Mémoire projet tut. P3

    • Oral project tut. P3

  • Health product development internship

    20 credits
    • P3 internship assessment

    • P3 internship report