The first part is the common sense of health law.
Part II Supervision and Management of Infectious Diseases
I. Overview: Concept and characteristics, legal basis, subject and scope, characteristics of infectious diseases, legal infectious diseases, common and important infectious diseases, epidemic classification and disposal of infectious diseases.
Prevention and supervision: routine preventive measures, key preventive measures, monitoring system, early warning system, immunization planning, vaccine circulation and vaccination management.
Three. Control and supervision: the spread and popularization of infectious disease control measures, sudden infectious disease control measures, epidemic situation report, notification and announcement, supervision and management contents.
Disinfection and isolation health supervision: supervision of disinfection and disposal, disinfection and isolation protection measures and legal responsibilities of infectious sources, places, articles and medical wastes, and supervision of production enterprises in disinfection products and disinfection products.
V. Supervision of pathogenic microorganism laboratories: classification of pathogenic microorganisms, biosafety level of pathogenic microorganism laboratories, establishment of laboratories and infection control, bacterial (virus) seed bank, sample collection, transportation and preservation.
Part III Health Supervision and Management in Public Places
Part IV Supervision and Management of Medical Services
Part V Drug Supervision and Administration
I. Overview: definition and classification of drugs, drug quality, drug standard system, drug management legal system, drug use principle, basic drug system, rational drug use policy, regulatory subject, regulatory content and legal responsibility.
2. Drug R&D and registration management: legal basis, drug R&D, clinical trials, drug registration, intellectual property rights, drug names and trademarks, and adverse drug reactions.
Monitoring, post-marketing re-evaluation and drug information management should be carried out.
Three. Drug marketing license holder: the definition, rights and obligations, drug quality traceability system, drug reevaluation system, annual report system and legal responsibility of drug marketing license holder.
Four. Supervision and management of drug production: legal basis, concept of drug production, drug production license, good manufacturing practice (GMP) and contents of drug production supervision.
Verb (abbreviation of verb) supervision and management of drug trading: legal basis, classification and operation mode, drug trading license and quality management norms of drug trading enterprises.
(GSP), drug packaging and labeling instructions, prescription drugs and over-the-counter drugs, basic requirements for drug circulation management, drug advertising management, and drug Internet service management. Intransitive Verb Pharmaceutical Affairs Management in Medical Institutions: Legal Basis and Pharmaceutical Affairs Management in Medical Institutions
Basic knowledge, drug supply management, drug classification management regulations, preparation management, intravenous drug configuration, dispensing business and prescription management regulations.
7. Supervision and management of special drugs: legal basis, basic knowledge of narcotic drugs and psychotropic drugs, basic knowledge of toxic drugs for medical use, basic knowledge of radioactive drugs, narcotic drugs, psychotropic drugs and toxic substances for medical use, production and operation of radioactive drugs, pharmaceutical affairs in medical institutions and other management regulations, supervision and management contents and methods.
Eight, supervision and management of traditional Chinese medicine: the concept of traditional Chinese medicine, Chinese herbal medicine, Chinese herbal medicine pieces, Chinese patent medicine management regulations, Chinese herbal medicine variety protection, Chinese herbal medicine production quality management, supervision content and methods.
Nine. Supervision and management of medical devices: definition and classification of medical devices, supervision cases
Keywords purpose and principle, legal system of medical device management, medical device quality management system,
R&D and medical device registration management, medical device production supervision and management, medical device operation supervision and management, and medical device post-marketing management.
X supervision and management of cosmetics: the concept and classification of cosmetics, the definition of special-purpose cosmetics, the concepts and main contents of prohibited substances and restricted substances of cosmetics, the naming rules of cosmetics, the identification of cosmetics, the declaration of cosmetics, the sampling monitoring of cosmetics, the definition of cosmetic adverse reactions, the main cosmetic adverse reactions, and the significance and working mechanism of cosmetic adverse reaction monitoring.
Part VI Food Safety Supervision
Part VII Medical Safety Management