Industrial pharmacy REPLICA LATINA

General expected learning outcomes The Industrial Manufacturing of Medicines course aims to provide the knowledge related to the marketing procedure (AIC), to the industrial plant engineering, to the production processes of drugs, to the Good Manufacturing Practice (GMP) and Standards. At the same time the students will acquire the competences of the pharmaceutical technologies used in the industrial production and packaging of medicines. The course will also allow the students to be informed about the regulations that are needed, and later applied, for an appropriate planning and validation for the industrial production of medicines. During specific moments of discussion and deeper insight the students will have the opportunity to contact people that exert their professional activity in pharmaceutical companies. Industrial Manufacturing of Medicines is an interdisciplinary course that has an applicative approach which will allow, after the final degree (laurea specialistica), to enter the working world because he/she will be able to face, analyze and evaluate the various problems related to the industrial processes that are needed for medicine marketing. Specific expected learning outcomes 1. Knowledge and understanding Regulation, technologies, processes, and plant engineering knowledge required to operate with high qualification in the manufacturing industry of traditional, innovative, and biotechnological medicines will be acquired. 2. Applying knowledge and understanding At the end of the course the student will be able to apply the information given during the lectures that will face the specific topics related to the chemical-pharmaceutical industry, both from a technical point of view as well as in accordance with current regulations. The student will be able to follow the various phases of drug production for the different dosage forms. At the same time, the acquired preparation, will allow him/her to face all the steps and problems related to formulation, regulation, safety, and validation. 3. Making judgements The “classical” lectures will include discussion and assessment method moments, together with programmed interactions with people directly involved in pharmaceutical companies, will allow the students to organize and follow a specific project. Taking into consideration one of the topics that were faced during the course they will be able to write (singularly or as a team) a report that can demonstrate their autonomous ability to evaluate the technological, regulatory and safety issues related to the manufacturing of the various dosage forms. The students will be divided in small groups and then it will be requested to apply, according to a more practical approach, the information acquired during the first part of the lesson. For a deeper insight, experts in the specific fields faced during the lessons will be invited. 4. Communication skills During the course, several moments will be devoted to debates, discussions, and roundtables under the professor’s supervision; in this sense specific selected topics will be assigned to the students. This activity, that will be carried out both individually and as small groups, will allow to evaluate the communication skills of the students with respect to the acquired information. These sessions will be important to develop the ability to critically evaluate technological, regulatory and safety issues related to the manufacturing of the various dosage forms. In these occasions the students will also develop their ability to properly report on the selected topics in front of the professor and their colleagues (peer assessment). 5. Learning skills Both theoretical and practical information that will be given during the course is also intended to develop the personal ability of an autonomous and independent learning (continuous education). This will allow the students to critically evaluate the medicine production and validation processes, and to appropriately understand, and correctly apply, the current regulations. Furthermore, the preparation acquired during the course will allow the students to keep his/her information and skills always updated in the field of industrial pharmaceutical production: a world which is in continuous and rapid evolution.