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