Legislation and Regulatory Affairs of Medicinal Products

Code:

MI075179

Acronym:

LRM

Keywords
Classification	Keyword
OFICIAL	Social Science

Instance: 2013/2014 - 1S

Active?	Yes
Responsible unit:	Pharmaceutical Technology Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	36	Official Curriculum	5	-	4	52	108

Teaching language

Portuguese

Objectives

Provide knowledge of the terminology and concepts used at national and European level in the field of drug laws and regulations and the technical and scientific aspects inherent to medicines while giving students the right skills to a good professional performance in different areas of legislation and regulation of medicines, particularly in the regulatory content related to the pharmaceutical development of formulations, definition and validation of methodologies for the production of medicines.

 Are also approached aspects associated with the characterization of materials and engineering streams processes and methodologies in the preparation, manufacture and control, in addition to the conditions of storage, as well as checking the stability and shelf-life definition of medicinal products for human or veterinary use.

Learning outcomes and competences

Prepare pharmacists with expertise in the area of regulatory of medicines.

Working method

Presencial

Program

Regulatory framework of the area of the medicine.

Main historical elements in European and North American context.

The construction of a global system and the ICH.

The framework for transnational cooperation of regulatory authorities and the positioning of companies.

 The Regulatory System of the medicinal product in the European Union.

The construction of the Europe of the Medicine.

The European regulations in the field of medicine.

Quality.

Biotechnology.

Preclinical safety.

Clinical efficacy and safety.

The European system and its operationalization.

National and decentralized procedure  system (mutual recognition).

Centralized procedure and EMA.

The functioning of the CHMP and several CXMP.

 The scientific advice of the EMA/CHMP.

The European coordination of regulatory authorities and the freedom of movement.

Mandatory literature

EMA; EMA Scientifig guidelines

Teaching methods and learning activities

Lectures (2h/week); Theoretical and practical classes (2h/week): Power Point presentations.  The teacher in charge is available for attendance of students in hours announced at the beginning of the semester and by appointment at any other time.

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	60,00
Trabalho escrito	40,00
Total:	100,00

Eligibility for exams

The student’s assistance to lectures is not obligatory.

Calculation formula of final grade

The final grade is weighted as follows: 55% of the written test + 45% of theoretical-practical work.  Students with final scores equal to or greater than 9.5 values are considered approved.  Students with final scores less than 9.5 values are considered disapproved.