Objectives

General aims
This course leads students towards the learning of drug invention, starting from banch drug discovery, to the applied research, drug development up to the marketing. Moreover, special focus will be on regulatory affairs legislation and the complex procedures for a drug candidate to fill the safety requirements and efficacy that National and European Regulatory Agencies require for authorization.

Specific aims
1. Knowledge and understanding
The students will know and will be able to understand all aspects about basic of drug discovery, preclinical development and clinical trial of drug candidate. Knowledge of international guidelines, Italian and European rules for clinical trials approval and marketing, and activity of regulatory Authority.

2. Applying knowledge and understanding
At the end of the course the student, applying the aquired knowledge, will be able to orient him/herself inside the different aspects of the drug research and development and inside the procedures and rules of the registration process in Italy and Europe.

3. Making judgement
At the end of the course the student will be able to evaluate a drug development process and the right regulatory process. This critical and judgement ability, will be obtained thanks to continuous interactivity hold during the course. In fact the teacher will ask questions very frequently to stimulate students to link the actual topics to all the topics studied up to that time, so that the study will not be isolated, but integrated matter with the aquired knowledge.

4. Communication skills
Judgment of the student study will be realized by oral exame about all the program topics, testing the communications ability of the student about the matter.

5. Learning skills
The student will find details of lessons on the suggested textbooks, slides, notes, and in the scientific literature and will have ability to use them to pursue an indipendent preparation. This will be useful to teh studento to find again topics of the matter also in future time when the memory of the concepts described in the lesson room will be softer. The textbooks will remain the benchmark for student that will be able to find again details of forgotten notions.

Channels

NESSUNA CANALIZZAZIONE

ROBERTO DI SANTO ROBERTO DI SANTO   Teacher profile

Exam reservation date start Exam reservation date end Exam date
03/12/2019 21/01/2020 22/01/2020
03/12/2019 08/03/2020 09/03/2020
03/12/2019 05/04/2020 06/04/2020
04/05/2020 15/05/2020 19/05/2020
03/12/2019 14/06/2020 18/06/2020
03/12/2019 05/07/2020 06/07/2020
03/12/2019 13/09/2020 14/09/2020
03/12/2019 30/09/2020 01/10/2020
03/12/2019 08/11/2020 09/11/2020
03/12/2019 10/12/2020 16/12/2020
Course sheet
  • Academic year: 2019/2020
  • Curriculum: INFORMAZIONE SCIENTIFICA SUL FARMACO
  • Year: Second year
  • Semester: Second semester
  • SSD: CHIM/08
  • CFU: 9
Activities
  • Attività formative affini ed integrative
  • Ambito disciplinare: Attività formative affini o integrative
  • Lecture (Hours): 72
  • CFU: 9
  • SSD: CHIM/08