ECTS
120 credits
Duration
2 years
Training structure
School of Pharmacy
Presentation
Specialized training in international regulatory affairs.
Objectives
Participation in the development of healthcare products through expertise in the regulatory environments of healthcare companies and products at the national, European, and international levels.
Know-how and skills
- Ensuring the formatting and consistency of active substance dossiers at the international level
- Ensure the formatting and consistency of the various modules of the international marketing authorization application dossier.
- Mastering the various channels for bringing a healthcare product to market internationally
- Know the procedures for modifying marketing authorization
- Understanding the European Union's arbitration procedures
- Mastering the legal environment for manufacturing healthcare products (EU, US, Japan, Canada)
- Mastering the legal environment for the distribution of medicines in the European Union
- Know the specific regulations governing particular drugs
- Understanding the different types of eHealth offerings and their legal framework
- Understanding the role and functioning of the relevant authorities (France, EU, USA, Canada)
- Ensure the drafting and validation of the labeling, summary of product characteristics, and package insert for a drug.
- Be able to propose strategies for bringing a drug to market or developing it.
- Ensuring the legality of advertising
- Knowing how to analyze and critique a clinical trial report or clinical trial publication
- Know the steps and criteria for accessing reimbursement and setting drug prices.
- Participate in pharmacovigilance activities (drafting risk management plans, periodic safety reports for a drug, risk minimization measures, management of reports)
- Check the compliance of the pharmacovigilance system's permanent file
- Understanding the legal environment surrounding dietary supplements
- Mastering legal tools for protecting innovation
- Be familiar with the specific aspects of subcontracting contract techniques.
- Learn about the various measures available to support innovation and small and medium-sized enterprises.
- Know and understand efficiency assessments and the main methodologies of pharmacoeconomics.
Organization
Knowledge assessment
Program
Select a program
M1 Medicinal Sciences and Health Products (P1)
Core Curriculum Units
15 creditsRegistration and Economy of Health Products
5 creditsAnalysis Techniques for Drug Quality Control
5 credits
Fundamentals of Health Product Engineering
5 creditsCHOICE 2 UEs
15 creditsChoose 2 or 3 out of 7
Pharmacokinetics, pharmacodynamics, and biopharmaceutics
5 creditsAdvanced Analysis Techniques for Media Development.
5 creditsIntroduction to aging and anti-aging
5 creditsKnowledge of the company and patent valuation
5 creditsDrug design: Introduction to drug design
5 creditsMicroscopy and spectroscopy for biology
Industrial development of aging models
5 credits
Long internship
15 creditsInternship
10 creditsTER course Regulatory environment
5 credits
M2 International Regulatory Environment for Healthcare Companies and Products
Admission
Admission requirements
In M1: Bachelor's degree in Chemistry – Bachelor's degree in Life Sciences – Bachelor's degree in Health Engineering.
Applications must be submitted online:
- If you are already a student at UM or another university, you can apply via the platform "Mon Master" . Don't forget to fill in and attach the course selection form with your preferences in order of priority to your application file.
- You are an international student and wish to continue your studies in France within our program. In this case, please follow theCampus France procedure.
- You are not (or have not been for more than a year) a student and would like to resume your studies through continuing education. In this case, please contact Mrs. Avelli in order to obtain administrative information.
In M2: State Diploma of Doctor of Pharmacy, Medicine, Dentistry, Veterinary Medicine.
Applications must be submitted online:
Apply