M2 Regulatory Affairs of the Health Industry

Apply for the degree
  • Places available
    32
  • Language(s) of instruction
    English
    French
Présentation
Objectives

The master is primarily intended for pharmacy students or pharmacists already working in the health products industry. It will allow them to apply for positions in charge of regulatory affairs in the health
products industry or predominantly regulatory positions within health authorities: ANSM, HAS ...
- Students, once graduated, must master all the regulations applicable to the health industries, as well as the status of various health products.
- Students must be able to apply their regulatory knowledge to specific cases likely to arise in the pharmaceutical, cosmetic or medical device industry. This requires a good legal mastery but also a perfect knowledge of all activities developed within a regulatory affairs department which deploys a cross-cutting activity.
Teaching in the form of lectures, conferences and projects will aim to transmit to students not only knowledge but also interpersonal skills to evolve in a service with multiple interactions.

Location
FONTENAY AUX ROSES
SCEAUX
Course Prerequisites

Applicants must have validated their fifth year of pharmacy and the pharmaceutical synthesis certificate or must be pharmacist. They must already have a good experience in the pharmaceutical industry through internships or salaried jobs. They must already have acquired professional attitude and reflexes and have a good spoken and written English.

Skills

  • Anticipate regulatory developments in the field of health products.

  • Identify the legal issues related to a file handled by a regulatory affairs department.

  • Autonomously apply the knowledge acquired to the different missions of a pharmacist in charge of regulatory affairs.

  • Combine theoretical knowledge and particularities of the environment in order to formulate operational proposals.

  • Explain within the company the regulatory constraints related to the activities carried out.

  • Report in a relevant way to colleagues and hierarchy.

Post-graduate profile

At the end of the training, graduates must be able to take up any regulatory affairs position within a health products industry. They must be able to carry out the various missions pertaining to such a position and master the transversal dimension of a regulatory affairs department within a pharmaceutical establishment.
Proficient in oral and written communication, they are able to combine theoretical knowledge and particularities of the environment in order to formulate operational proposals which can be implemented by the various departments of the company.

Career prospects

- Responsible for regulatory affairs: pharmaceutical, cosmetic and food industry, medical devices.
- Project manager in French and European agencies for health products (ANSM, EMA) and more generally in the administrations in charge of health (HAS, ARS).
- Legal departments of the pharmaceutical industry

Collaboration(s)
Laboratories

Groupe de Recherche et d'Accueil en Droit et Economie de la Santé.

Programme

Le S1 est constitué d'UE obligatoires qui permettent aux étudiants de maîtriser les contraintes réglementaires et économiques de leur futur environnement professionnel et d'acquérir une vision globale des Affaires réglementaires au sein des industries de santé.

Subjects ECTS Lecture directed study practical class Lecture/directed study Lecture/practical class directed study/practical class distance-learning course Project Supervised studies
Contexte économique et social 12 90
Environnement juridique 10 84
Subjects ECTS Lecture directed study practical class Lecture/directed study Lecture/practical class directed study/practical class distance-learning course Project Supervised studies
Pilotage stratégique 8 40

Le S2 est constitué d'UE obligatoires qui permettent aux étudiants de maîtriser les connaissances technico-réglementaires indispensables à un chargé d'affaires réglementaires et d'acquérir les pratiques qui feront de lui un professionnel opérationnel.

Subjects ECTS Lecture directed study practical class Lecture/directed study Lecture/practical class directed study/practical class distance-learning course Project Supervised studies
Réglementation des produits de santé 10 73 15
Subjects ECTS Lecture directed study practical class Lecture/directed study Lecture/practical class directed study/practical class distance-learning course Project Supervised studies
Approches professionnelles 5 24 15
Stage ou alternance en entreprise 15
Modalités de candidatures
Application period
From 15/03/2024 to 15/05/2024
Compulsory supporting documents

  • Motivation letter.

  • All transcripts of the years / semesters validated since the high school diploma at the date of application.

  • Certificate of English level.

  • Curriculum Vitae.

Additional supporting documents

  • Certificate of French (compulsory for non-French speakers).

    (Level B2 required)

  • VAP file (obligatory for all persons requesting a valuation of the assets to enter the diploma).

  • Supporting documents :
    - Residence permit stating the country of residence of the first country
    - Or receipt of request stating the country of first asylum
    - Or document from the UNHCR granting refugee status
    - Or receipt of refugee status request delivered in France
    - Or residence permit stating the refugee status delivered in France
    - Or document stating subsidiary protection in France or abroad
    - Or document stating temporary protection in France or abroad.

Contact(s)
Course manager(s)
Déborah ESKENAZY - deborah.eskenazy@universite-paris-saclay.fr
Administrative office
Marjolaine FLAUNET - marjolaine.flaunet@universite-paris-saclay.fr
Admission