Description
European and national legal framework for the development, distribution, and use of medicinal products for humans.
Alternative labels
pharmaceutical norms
pharmaceutical regulations
pharmaceutical laws
Skill type
knowledge
Skill reusability level
cross-sector
Relationships with occupations
Essential knowledge
Pharmaceutical legislation is an essential knowledge of the following occupations:
Pharmaceutical quality specialist: Pharmaceutical quality specialists perform inspections and precision measurements in order to test and ensure the quality of pharmaceutical products. They are involved in the whole development phase of a pharmaceutical product until it is ready for the market. This includes the process of acquiring clinical trial licences, advising the pharmaceutical development staff on regulatory requirements and evaluating the content of the package leaflet and other documentation on the product. Moreover, pharmaceutical quality specialists collect and evaluate information on side effects of the product and communicate this knowledge both internally and to the relevant authorities.
Pharmacologist: Pharmacologists study the manner in which drugs and medicaments interact with organisms, living systems, and their parts (i.e. cells, tissues, or organs). Their research aims at identifying substances that can be ingested by humans and that exert adequate biochemical functions for curing illnesses.
Optional knowledge
Pharmaceutical legislation is optional for these occupations. This means knowing this knowledge may be an asset for career advancement if you are in one of these occupations.
Lawyer: Lawyers provide legal advice to clients and act on their behalf in legal proceedings and in compliance with the law. They research for, interpret and study cases to represent their clients in a variety of settings such as courts and administrative boards. They create arguments on behalf of their clients for lawsuits in different contexts with the aim of finding a legal remedy.
Pharmaceutical engineer: Pharmaceutical engineers design and develop technologies used in pharmaceutical research and drugs manufacture, advising the pharmaceutical manufacturing plants to maintain and operate those technologies and ensuring the customers` and workers` safety requirements are met. They may also be involved in the conception and design of pharmaceutical manufacturing plants and research centers.
Chemical engineer: Chemical engineers design and develop large-scale chemical and physical production processes and are involved in the entire industrial process required for transforming raw materials into products.
Corporate lawyer: Corporate lawyers provide legal consulting services and representation to corporations and organisations. They give advice on matters relating to taxes, legal rights and patents, international trade, trademarks, and legal financial issues arising from operating a business.
References
- Pharmaceutical legislation – ESCO
