Curricular Unit:Code:
Regulations, Registries and Pharmaceutical Quality843RRQF
5MasterPharmaceutical Sciences3 ects
Learning Period:Language of Instruction:Total Hours:
Winter SemesterPortuguese/English39
Learning Outcomes of the Curricular Unit:
The purpose of this unit is to provide basic and specific knowledge about regulatory affairs, medicines, medical devices, cosmetics and food supplements market introduction and regulamentation, as well as the pharmaceutical quality demands for these products.
"1- Legal Framework of Health Products
2- Medicines, Medical Devices, Cosmetics and Hygienic Products, Food Supplements
3 – Regulation in the medicines life cycle
4 – Regulation of Medical Devices and Cosmetics
5 – Regulation of Food Supplements
6 - Inspection, control and quality conformity verification of pharmaceutical products
7 – Health Technologies Assessment
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
Learning about the organization and regulamentation of Medicines, Medical devices and Cosmetic and Hygienal Products is essential to acquire the competencies that are needed for the hospitalar and regulamentar areas. Students will learn the legal basis of the pharmaceutical products circuits, their market authorisation process, legal alterations, quality and safety control mechanisms and market withdrawls and recalls.
Teaching Methodologies (Including Evaluation):
In the theoretical classes, the concepts and theories that form the basis of the syllabus will be presented in a concise, organizational and descriptive way, encouraging the active participation of students whenever possible. This exhibition will be accompanied with suitable audiovisual material. In order to acquire the expected skills, students will be encouraged to deepen their knowledge and seek their practical application through: (i) analyses and application of relevant theoretical concepts in hypothetic real situations and (ii) discussion and reflection on relevant issues program. In tutorial sessions, the teacher will clarify the doubts and conduct the study of the student. The evaluation will be continuous, with the knowledge acquired validated by performing two written evaluations on dates marked in the beginning of the semester. The lack of an assessment implies the classification of 0 for purposes of calculating the final classification and no allocation of ECTS.
Demonstration of the Coherence between the Teaching Methodologies and the Learning Outcomes:
"The teaching methodologies presented here are based mainly on a skills development model, with a view to acquisition of knowledge and theoretical capabilities add value to the professional activity. In order to acquire the skills and competences expected, the students will be encouraged to deepen the knowledge acquired in theoretical classes (exhibition/participative character) and to seek their practical application (demonstrative/ participative character). The constant interaction between teacher and student in theoretical-practical classes will allow the adaptation of the student to the proposed objectives. Furthermore, the use of a set of study materials created purposely, as well as support sessions to answer questions (tutorial orientation), allow a high level of adjustment between the methodologies used and the objectives of the course. The assessment carried out in theoretical context will allow verifying the scientific expertise and systematization of knowledge acquired by students. All activities with evaluative nature will be awarded credits (ECTS) properly proportional to the number of total credits. ECTS planned for the work-study student will only be fully allocated or not, depending on the performance demonstrated by the student, in particular with regard to the planned acquisition of knowledge and skills. In addition to the assessments referred to, it will be given to students opportunities to demonstrate that it met the proposed objectives through evaluation moments if the teacher or the student understands the requests. These elements may be considered if it appears to benefit the student. "
Legislação Farmacêutica Compilada, Infarmed, Lisboa, 2015 ; Orientações Metológicas para Avaliação Tecnologias da Saúde, Infarmed, Lisboa, 2003
Lecturer (* Responsible):
Pedro Barata (