Health

International Regulatory Environment for Healthcare Companies and Products

  • ECTS

    120 credits

  • Duration

    2 years

  • Training structure

    Faculty of Pharmacy

Presentation

Specialized training in international regulatory affairs.

 

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Objectives

Participation in the development of healthcare products by mastering the regulatory environments of healthcare companies and products, at national, European and international levels

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Know-how and skills

  • Ensure that active substance dossiers are properly formatted and submitted at international level
  • Ensuring that the various modules of the marketing application file are properly formatted at the international level
  • Mastering the different ways of bringing a healthcare product to market internationally
  • Know the procedures for modifying marketing authorizations
  • Know the European Union's arbitration procedures
  • Master the legal environment of healthcare product manufacturing (EU, USA, Japan, Canada)
  • Master the legal environment of drug distribution in the European Union
  • Knowing the regulatory specifics of particular drugs
  • Understanding the different types of eHealth offerings and their legal framework
  • Know the role and functioning of the competent authorities (France, EU, USA, Canada)
  • Write and validate the labeling, summary of product characteristics and package insert for a drug.
  • Be able to propose strategies for marketing or developing a drug
  • Checking the legality of an advertisement
  • Analyze and critique a clinical trial report or publication
  • Understand the stages and criteria involved in accessing reimbursement and setting drug prices.
  • Participate in pharmacovigilance activities (drafting of risk management plans, periodic drug safety reports, risk minimization measures, management of reports).
  • Check the compliance of the pharmacovigilance system's permanent record
  • Knowing the legal environment of dietary supplements
  • Master the legal tools for protecting innovation
  • Know the specific aspects of subcontracting techniques.
  • Learn about the various measures available to support innovation and small and medium-sized businesses.
  • Know and understand efficiency opinions and the main methodologies of pharmacoeconomics
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Organization

Knowledge control

Program

Select a program

M1 Pharmaceutical Sciences and Health Products (P1)

  • Core UEs

    15 credits
    • English

      3 credits
    • Quality and technical/regulatory aspects: Technico réglem

      3.5 credits
      • Quality section

      • Technical and regulatory aspects

    • R&D and Drug Registration

      5.5 credits
    • Statistics and scientific watch

      3 credits
  • Registration and Health Product Economics

    5 credits
  • Analytical techniques for drug quality control

    5 credits
  • Toxicological investigation

    5 credits
  • Fundamentals of health product engineering

    5 credits
  • CHOICE 2 UEs

    15 credits
    • Choice of 2 or 3 from 7

      • Pharmacokinetics, pharmacodynamics and biopharmacy

        5 credits
      • Advanced analysis techniques for Medi development.

        5 credits
      • Introduction to aging and anti-aging

        5 credits
      • Corporate knowledge and patent valuation

        5 credits
      • Drug design: Introduction to drug design

        5 credits
      • Microscopies and spectroscopies for biology

      • Industrial development of aging models

        5 credits
  • Long course

    15 credits
  • Internship

    10 credits
  • TER Regulatory Environment track

    5 credits

M2 International Regulatory Environment of Businesses and Health Products

  • Specific courses

    • Market access and industrial valorization

      5 credits
    • European Union and national drug registration

      5 credits
    • International drug registration

    • Specific regulations

      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 Intern° regulatory environment course

    10 credits
  • International Regulatory Environment Internship

    20 credits

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 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 at

https://pharmacie.edu.umontpellier.fr/scolarite/admissions/

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How to register

Master 1

Master 2

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