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

M2 International Regulatory Environment for Business

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  • Specific regulations

    5 credits
  • Specific courses

    • Specific regulations

      5 credits
    • Market access and industrial valorization

      5 credits
    • European Union and national drug registration

      5 credits
      • Registration medoc UE CC

      • EU and national CT drug registration

    • International drug registration

  • Core syllabus

    • News and recent advances in drug science

      4 credits
    • Comnunication - Application of English

      3 credits
    • Project and risk management

  • European Union and national drug registration

    5 credits
    • Registration medoc UE CC

    • EU and national CT drug registration

  • International drug registration

  • EU MONTREAL

    10 credits
  • Tutored project Intern° regulatory environment course

    10 credits
    • Tutored project dissertation p1

    • Oral tutored project p1

  • International Regulatory Environment Internship

    20 credits
    • P1 internship assessment

    • P1 internship report