Training for Quality, Environment, Safety, Ethics, GMP

A.Y. 2021/2022
Overall hours
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.
Course syllabus and organization

Single session

Lesson period
First semester
More specific information on the delivery modes of training activities for academic year 21/22 will be provided over the coming months based on the evolution of the public health situation.
Course syllabus
1) Quality Management System according to ISO9001 standard
Principles and implementation strategies of the standard, providing examples from laboratories of clinical chemistry.
2) Ethical issues in drug development
Steps of Drug development process, key principles for ethical conduct and current national and international regulations.
3) Good Manufacturing Practice (GMP)
Basic requirements for the manufacturing of medicinal products for humans and animals according to GMP and current international regulations.
4) Health and Safety Systems
Basic processes and figures of health and safety protection system at workplace.
5) Risk assessment
Basic processes for risk assessment and management starting from the chemical and toxicological profiles of substances.
6) Environmental Management System
Principles and implementation strategies of the ISO 14001 standard for the reduction of environmental impact.
Prerequisites for admission
Teaching methods
Lessons and workgroups.
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 to verify 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.
BIO/14 - PHARMACOLOGY - University credits: 4
Lessons: 32 hours
Professor: Gomaraschi Monica