M2 International Development and Registration of Medicine and Health Products

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The objectives of this program are to train drug professionals by deep diving into the scientific and regulatory aspects of pre- and post- marketing authorisation drug development and registration, at a strategic and operational levels, with an international focus: European Union, USA, Canada, Switzerland, Australia, Japan, South-East Asia (China, Korea, India...), ASEAN region, Russia and EEU region, Central and Eastern region, Middle-East region, Africa, Latin America (Argentina, Brazil, Mexico...)...
This program leads to positions in Regulatory Affairs in pharmaceutical companies (headquarter or affiliates), pharmaceutical regulatory affairs consulting services or national and international agencies of health products for humans or animals, in numerous countries around the world, with the following missions: regulatory strategy of drug development and registration, drug product post-approval activities, pharmacovigilance and risk management, regulatory compliance, regulatory intelligence...

Course Prerequisites

“This course is open to students following either pharmaceutical, medical or veterinary studies, or agronomic or scientific studies, holders of a M1 or equivalent, in particular holders of an engineering degree. The essential prerequisites are a good scientific knowledge of the drug and its development, an advanced level in English and experience (internship or other) in the field of regulatory affairs.”

  • To master personal and business communication skills in French and English languages.

  • To apply the principles of business project management.

  • To master bibliographic research and sources of information.

  • To analyze and criticize documentation (in particular health regulations) and scientific articles.

  • To elaborate a regulatory strategy to support drug development and registration in an international environment.

Post-graduate profile

Young graduates, specialized in regulatory affairs with a strategic vision of the drug the development and registration environment and having, through their internship, a first experience abroad or in a national structure with international interaction.

Career prospects

Opportunities are positions in Regulatory Affairs within pharmaceutical companies (head company or affiliates), consulting companies or national and international public health institutions, with the main missions:
- drug development and registration
- pharmacovigilance and risk management
- regulatory compliance
- market access
- regulatory intelligence ...


Lipides, Systèmes Analytiques et Biologiques
Signalisation et Physiopathologie Cardiovasculaire.


Le premier semestre est consacré à l'acquisition des aspects scientifiques et réglementaires du développement pré et post AMM et de l'enregistrement des médicaments, tant sur les aspects stratégiques qu'opérationnels, dans une dimension internationale.

Matières ECTS Cours TD TP Cours-TD Cours-TP TD-TP A distance Projet Tutorat
Stratégie de développement et d'enregistrement global d'un nouveau médicament 5 10 30 60
Développement non clinique et clinique du Médicament 9 70 20 30
Développement et Enregistrement des produits issus des biotechnologies et thérapies innovantes 4 35 5
Développement et enregistrement des médicaments hors Union Européenne 5 40 10
Développement et enregistrement des médicaments dans l'Union Européenne 4 35 5
Activités péri- et post- Autorisation de Mise sur le Marché 3 30 10 0

Le second semestre est consacré au stage en milieu professionnel.

Matières ECTS Cours TD TP Cours-TD Cours-TP TD-TP A distance Projet Tutorat
Stage 30 18
Modalités de candidatures
Application period
From 15/03/2021 to 08/05/2021
Compulsory supporting documents
  • Certificate of English level.

  • Motivation letter.

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

  • Curriculum Vitae.

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

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

  • Curriculum EU (description of the units of education followed) of the last two years.

  • Choice sheet of M2 (obligatory for the candidates registered in M1 at the University Paris-Saclay) to download on https://www.universite-paris-saclay.fr/en/admission/apply-master-programmes.

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