ECTS
120 credits
Duration
2 years
Training structure
Faculty of Pharmacy
Presentation
Specialized training in international regulatory affairs.
Objectives
Participation in the development of health products by mastering the regulatory environment of health companies and products, at the national, European and international levels
Know-how and skills
- Ensure the formatting and regularity of active substance dossiers at the international level
- Ensure the formatting and regularity of the various modules of the marketing application file at the international level
- Master the different ways of marketing a health product at the international level
- Knowing the procedures for modifying marketing authorizations
- To know the arbitration procedures of the European Union
- Master the legal environment of health products manufacturing (EU, USA, Japan, Canada)
- To master the legal environment of the distribution of medicines in the European Union
- To know the regulatory specificities of particular drugs
- Know the different types of eHealth offers and their legal framework
- Know the role and functioning of the competent authorities (France, EU, USA, Canada)
- Ensure the writing and validation of the labeling, the summary of product characteristics and the package insert of a drug.
- Be able to propose strategies for marketing or developing a drug
- Ensuring the legality of an advertisement
- Know how to analyze and critique a clinical trial report or publication
- Know the steps and criteria for access to reimbursement and pricing of drugs.
- Participate in pharmacovigilance activities (drafting of risk management plans, periodic drug safety reports, risk minimization measures, management of reports)
- Monitor the compliance of the pharmacovigilance system's permanent record
- To know the legal environment of food supplements
- Mastering the legal tools for protecting innovation
- Know the specific aspects of the contractual technique of subcontracting.
- To know the different measures to support innovation and small or medium-sized enterprises.
- Know and understand efficiency opinions and key pharmacoeconomic methodologies