Curricular Unit:			Code:
Research and Clinical Trials			1069IECL
Year:	Level:	Course:	Credits:
1	Postgraduate	Regulatory Affairs of Medication and Health Products	0,8 ects
Learning Period:		Language of Instruction:	Total Hours:
		Portuguese/English	10
Learning Outcomes of the Curricular Unit:
In module 5 - Research and Clinical Trials - of the Postgraduate Diploma in Regulatory Affairs of Medicines and Health Products, the competencies to be acquired include: knowing the experimental medicine circuit; obtaining the fundamental knowledge related to clinical research and clinical development of medicines and medical devices.
Syllabus:
1 - Ethics fundamentals. Clinical research law. Ethics committees (CEIC; CES) ORBEA and DGAV. Professional ethics. 2 - Clinical trials design. Clinical trials - regulation. Good Clinical Practice ICH. Protocol. Informed consent. Investigator's brochure. 3 - Investigational drug. Circuit Experimental Medicinal Products Statistics and epidemiology applied to clinical development of medicines. 4 - Statistics and epidemiology applied to the clinical development of medicines.
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
The postgraduate course in Regulatory Affairs in Medicines and Health Products aims to prepare highly qualified professionals in regulatory affairs related to the area of medicines, medical devices, cosmetic and body hygiene products and food supplements, to work in the different areas of regulatory affairs. The program contents of Module 5 aim at the acquisition of competences regarding regulatory aspects for the conduct of clinical research for the clinical evaluation of medicines and other health products.
Teaching Methodologies (Including Evaluation):
The teaching regime of the Postgraduate Course in Regulatory Affairs of Medicines and Health Products is distance learning (online), through the CANVAS platform. The course will be assessed through attendance and participation during each session of the course and the presentation of a final paper/report on one of the topics taught during the course. The topic of the work will be selected by the student himself according to student`s professional interests.
Demonstration of the Coherence between the Teaching Methodologies and the Learning Outcomes:
The evaluation in each module of the course will be carried out by the presence and interest/participation during each session. The final evaluation of the course through a final work/report will validate the scientific competencies and the systematisation of the knowledge acquired by the students. Additionally, the completion of this work / final report allows to deepen the knowledge in a more specific area of the course according to professional interests.
Reading:
EMA webpage - https://www.ema.europa.eu/en INFARMED webpage - https://www.infarmed.pt/ INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH) - ICH HARMONISED GUIDELINE - Good Clinical Practice