ECTS
120 credits
Duration
2 years
Training structure
Faculty of Pharmacy
Presentation
Specialized training in international regulatory affairs.
Objectives
Participation in the development of healthcare products by mastering the regulatory environments of healthcare companies and products, at national, European and international levels
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
Organization
Knowledge control
Program
Select a program
M1 Pharmaceutical Sciences and Health Products (P1)
Core UEs
15 creditsRegistration and Health Product Economics
5 creditsAnalytical techniques for drug quality control
5 creditsToxicological investigation
5 credits
Fundamentals of health product engineering
5 creditsCHOICE 2 UEs
15 creditsChoice of 2 or 3 from 7
Pharmacokinetics, pharmacodynamics and biopharmacy
5 creditsAdvanced analysis techniques for Medi development.
5 creditsIntroduction to aging and anti-aging
5 creditsCorporate knowledge and patent valuation
5 creditsDrug design: Introduction to drug design
5 creditsMicroscopies and spectroscopies for biology
Industrial development of aging models
5 credits
Long course
15 creditsInternship
10 creditsTER Regulatory Environment track
5 credits
M2 International Regulatory Environment of Businesses and Health Products
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 already a student at UM or another university, you can apply via the platform. “My Master” . Don’t forget to fill out and attach the course selection form with a ranking of choices in your application.
- 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