This course is designed to provide the aspiring Qualified Person and pharmaceutical quality professional with the knowledge and understanding of international pharmaceutical legislation so that they can carry out their duties with skill and authority. We will describe the laws, regulations and guidance that dictate how we must work on a daily basis, we will explain why these laws exist and how they come into being, we will describe the roles and responsibilities of the major international regulatory agencies and we will emphasize the key role that QP and pharmaceutical professionals must play to ensure compliance with international legislation in the interest of patient safety.
Planned learning outcomes:
- Possess the skills of systematic interpretation of legislation and judicial practice applicable to legal relations in the field of circulation of medicines, solving complex regulatory issues of the industry,
- Know the basic requirements for the circulation of medicines on the territory of the European Union,
- Understand how to navigate the legal framework governing each of the components of the appeal, competently apply the provisions of the legislation governing various aspects of pharmaceutical law, analyze contractual ones