Training for Quality, Environment, Safety, Ethics, Gmp
A.Y. 2023/2024
Learning objectives
Aim of the course is to provide information on the following relevant aspects of the pharmaceutical field: Quality and Environmental Management Systems, Health and Safety Management Systems, Ethic issues in pre-clinical and clinical development of drugs, Good Manufacturing Practice for pharmaceutical products.
Expected learning outcomes
Ability to work in a ISO9001 Quality management context;
Ability to work in a ISO14001 Environmental management context;
Knowledge of current regulations on workplace Health and Safety system;
Knowledge of current regulations on animal and human studies;
Ability to work according to Good Manufacturing Practices.
Ability to work in a ISO14001 Environmental management context;
Knowledge of current regulations on workplace Health and Safety system;
Knowledge of current regulations on animal and human studies;
Ability to work according to Good Manufacturing Practices.
Lesson period: First semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course can be attended as a single course.
Course syllabus and organization
Single session
Responsible
Lesson period
First semester
Course syllabus
1) Introduction to the study of toxicology
Experimental models for the assessment of pharmacology and toxicology of new molecules:
- Drug screening and discovery
- In silico and in vitro models
- In vivo models
- Studies on humans.
Ethical conduct and current national and international regulations for animal and clinical studies.
Bibliographic resources:
- Use of public databases
- Structure and comprehension of scientific publications.
2) Health and Safety Systems
Basic processes and figures of health and safety protection system at workplace.
Basic processes for biological and chemical risk assessment in laboratory.
3) Quality Management Systems
Principles and implementation strategies of the ISO9001 and ISO14001 standards in laboratories of clinical chemistry.
Experimental models for the assessment of pharmacology and toxicology of new molecules:
- Drug screening and discovery
- In silico and in vitro models
- In vivo models
- Studies on humans.
Ethical conduct and current national and international regulations for animal and clinical studies.
Bibliographic resources:
- Use of public databases
- Structure and comprehension of scientific publications.
2) Health and Safety Systems
Basic processes and figures of health and safety protection system at workplace.
Basic processes for biological and chemical risk assessment in laboratory.
3) Quality Management Systems
Principles and implementation strategies of the ISO9001 and ISO14001 standards in laboratories of clinical chemistry.
Prerequisites for admission
None
Teaching methods
Lessons and workgroups. Attendance is mandatory.
Teaching Resources
Educational material is available on Ariel website. It consists of: slides, ISO standards, national and international guidelines and laws.
Assessment methods and Criteria
Oral exam; questions are aimed at verifying the student's knowledge on the course's topics using adequate terms. In itinere tests will not be performed. Evaluation is expressed as a score.
Educational website(s)
Professor(s)