Gaogang 1875
Outline of Jiangsu Higher Education Self-study Examination
0 1763 pharmaceutical affairs management (2)
Editor of Nanjing Medical University (202 1)
Jiangsu province higher education self-study exam Committee office
First, the nature of the course and its purpose and requirements.
(A) the nature and characteristics of the course
The course of Pharmaceutical Administration is an important specialized course for the pharmacy major (independent undergraduate course) in our province's higher education self-taught examination, and it is an important part of the necessary knowledge for pharmaceutical workers. Its task is to cultivate the legal view of the self-taught candidates of pharmacy specialty. Candidates learn the basic knowledge of pharmaceutical affairs management, pharmaceutical professional ethics and knowledge of pharmaceutical laws and regulations systematically, so as to understand whether the practice behavior in pharmaceutical related work is correct, the basic requirements of professional ethics and the problems and directions in the development of pharmaceutical affairs management, and cultivate qualified talents for the development of pharmaceutical industry.
This course is divided into fourteen chapters:
The first chapter is the introduction, which mainly introduces the related concepts of pharmaceutical affairs management, the emergence and development of pharmaceutical affairs management and its disciplines at home and abroad, the research contents and methods of pharmaceutical affairs management, the relationship between pharmaceutical affairs management and related disciplines, and the teaching contents, teaching requirements and teaching methods of pharmacology.
The second chapter is about drugs and drug management system, which mainly introduces what drugs are, their characteristics and how to manage them. At different social stages, different angles or viewpoints will have different interpretations. This chapter will explain these problems from the legal and sociological perspectives.
The third chapter is the drug organization and drug supervision system, which mainly introduces the composition and division of responsibilities of the current drug supervision and management institutions in China, the drug technical supervision institutions and their corresponding functions, as well as the reform and evolution process of the drug supervision and management system in China.
The fourth chapter is about pharmacists and pharmaceutical service management, which mainly introduces the related concepts of pharmacists, the contents, methods and management of pharmaceutical services, and the current situation of pharmaceutical services abroad. And the meaning of pharmaceutical professional ethics, pharmaceutical professional ethics and code of conduct, and international pharmacist professional ethics; At the same time, the pharmacist ethics is introduced.
The fifth chapter is the legislation of pharmaceutical affairs management, which mainly introduces the legal basis of pharmaceutical affairs management legislation, the main components of China's current pharmaceutical affairs legal system, and explains the legal responsibilities involved, in addition to the relevant contents of foreign pharmaceutical affairs management legal system.
Chapter VI Drug Registration Management mainly introduces the laws and regulations system of drug registration management in China, the related concepts of drug registration management, and the procedures and regulations of various drug registration.
Chapter VII Drug Production Management, which mainly introduces the concepts and characteristics of drug production and drug production management, the provisions for examination and approval of the establishment of drug production enterprises and the management of drug production licenses; Main contents and characteristics of GMP in China; Management of entrusted production of drugs, holders of drug marketing licenses and legal responsibilities related to drug production.
Chapter VIII Drug Management mainly introduces the definition and classification of drug trading, the characteristics of drug trading activities, the management of drug trading enterprises, the supervision and management of drug circulation, the quality management of drug wholesale and retail enterprises, the quality management norms of drug trading, the management of drug trading on the Internet and the relevant legal responsibilities of drug trading.
Chapter 9: Pharmaceutical Affairs Management in Medical Institutions, which mainly introduces the composition of pharmaceutical affairs organizations in medical institutions in China, doctors' prescriptions, single-dose prescriptions, preparations prepared by medical institutions, licenses of medical institutions and relevant regulations on prescriptions prepared by pharmacists.
Chapter 10 is about post-marketing supervision and management of drugs, which mainly introduces post-marketing re-evaluation, reporting and monitoring of adverse drug reactions, drug recall and other related contents.
Chapter XI Management of Special Drugs, which mainly introduces the related concepts of special drugs and the general situation of control at home and abroad, as well as the supervision and management of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and stimulants, compound preparation vaccines containing special drugs, precursor chemicals and vaccines.
Chapter 12 is the management of traditional Chinese medicine, which mainly introduces the related concepts of traditional Chinese medicine, the general situation of the development of traditional Chinese medicine industry, the relevant strategies of national modernization of traditional Chinese medicine, and the relevant legal provisions and systems in the management of traditional Chinese medicine, including the cultivation of traditional Chinese medicine, the production and dispensing of decoction pieces, the protection of traditional Chinese medicine varieties, and the supervision of import and export.
Chapter 13 is drug information management, which mainly introduces the main contents of drug information management, especially the laws and regulations on drug instructions and labels, drug advertisements and drug information services on the Internet.
Chapter 14 is the protection of medical intellectual property rights, which mainly introduces the concept and protection system of medical intellectual property rights, and introduces the management regulations and legal responsibilities related to medical intellectual property rights from the aspects of medical patent protection, medical trademark protection, medical trade secret protection and undisclosed data protection.
Through the study of this course, self-taught candidates should be familiar with and understand the basic knowledge of pharmaceutical affairs management, pharmaceutical laws and regulations, pharmaceutical professional ethics knowledge, and master the knowledge and theory of pharmaceutical affairs management and regulations directly related to pharmaceutical work. In the process of learning, we must pay attention to integrating theory with practice, think more, ask more questions and discuss more, so as to deepen our understanding and mastery of basic knowledge and theory.
(B) the basic requirements of this course
Through the study of this course, candidates should meet the following requirements:
1. Understand the importance of pharmaceutical affairs management in pharmaceutical work;
2. Master the basic knowledge and theory of pharmaceutical affairs management required for pharmaceutical work;
3. Understand and master the basic knowledge and theory of pharmaceutical affairs management directly and closely related to pharmaceutical work.
Click to download: 0 1763 Pharmaceutical Administration (II) (Gaogang 1875) full version.
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