ECTS
120 credits
Duration
2 years
Training Structure
School of Pharmacy
Overview
Specialized training in international regulatory affairs.
Objectives
Contributing to the development of healthcare products by understanding the regulatory environments governing healthcare companies and products at the national, European, and international levels
Expertise and Skills
- Ensure the proper formatting and consistency of active ingredient dossiers at the international level
- Ensure the proper formatting and consistency of the various modules in the international marketing authorization application dossier
- Understand the various pathways for bringing a health product to market internationally
- Understand the procedures for amending a marketing authorization
- Understanding the European Union’s arbitration procedures
- Understanding the Legal Framework for the Manufacture of Health Products (EU, U.S., Japan, Canada)
- Understanding the Legal Framework Governing the Distribution of Medicines in the European Union
- Understand the specific regulatory requirements for particular drugs
- Understanding the Different Types of eHealth Services and Their Legal Framework
- Understand the role and operations of the relevant authorities (France, the EU, the U.S., and Canada)
- Ensure the drafting and approval of the labeling, the summary of product characteristics, and the package insert for a drug.
- Be able to propose strategies for bringing a drug to market or for its development
- Ensure that an advertisement complies with the law
- Knowing how to analyze and critique a clinical trial report or a clinical trial publication
- Understand the steps and criteria for obtaining reimbursement and setting drug prices.
- Participate in pharmacovigilance activities (drafting risk management plans, periodic safety update reports, and risk minimization measures; managing adverse event reports)
- Verify the compliance of the pharmacovigilance system’s permanent record
- Understanding the Legal Framework for Dietary Supplements
- Mastering the Legal Tools for Protecting Innovation
- Understand the specific aspects of subcontracting contract law.
- Learn about the various measures designed to support innovation and small and medium-sized enterprises.
- To be familiar with and understand efficiency assessments and the main methodologies of pharmacoeconomics
Organization
Knowledge Assessment
Program
Select a program
M1 Pharmaceutical Sciences and Health Products (P1)
UEs Core Curriculum
15 creditsRegistration and Economics of Health Products
5 creditsAnalytical Techniques for Drug Quality Control
5 credits
Fundamentals of Healthcare Product Engineering
5 creditsCHOOSE 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 creditsUnderstanding the Company and Maximizing the Value of Patents
5 creditsDrug Design: An Introduction to Drug Design
5 creditsMicroscopy and Spectroscopy for Biology
Development of Aging Models in Industry
5 credits
Long-term internship
15 creditsInternship
10 creditsTER Course: Regulatory Environment
5 credits
M2 International Regulatory Environment for Healthcare Companies and Products
Admission
Admission Requirements
In the first year of a master's program (M1): Bachelor's in Chemistry – Bachelor's in Life Sciences – Bachelor's in Health Engineering.
Applications are submitted online:
- If you are already a student at UM or another university, you can apply through the “Mon Master” platform . Don’t forget to fill out and attach the program selection form—including your ranked list of choices—to your application.
- If you are an international student and would like to pursue your studies in France as part of our program, please follow theCampus France procedure.
- You are not a student (or have not been one for more than a year) and would like to resume your studies through continuing education. In that case, please contact Ms. Avelli in order to obtain administrative information.
At the M2 level: State-Awarded Doctorate in Pharmacy, Medicine, Dentistry, or Veterinary Medicine.
Applications are submitted online:
Apply
Registration Procedures
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