Legislation and Regulatory Affairs of Medicinal Products

Code:

MI075179

Acronym:

LRM

Keywords
Classification	Keyword
OFICIAL	Social Science

Instance: 2020/2021 - 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	137	Official Curriculum	5	-	3	52	81

Teaching language

Portuguese

Objectives

To Understand why medicines must  be authorized and the design of the marketing authorization system.

To Know the terminology and concepts used at national and European level in the area of drug law and regulation, namely in pharmaceutical development, elaboration and validation of methods and processes.

To Know and understand the regulation of aspects associated with the material flows, preparation and control of medicinal products for human or veterinary use, as well as with the evaluation of stability and definition of shelf life.

 

Learning outcomes and competences

Prepare pharmacists  to understand and participate in the preparation of a marketing authorization application for a medicinal product, particularly CTD module 3.

Transversal competencies:

-cognitive: analytical and critical skills;

-methodological: time management, planning skills and digital skills;

-social: interpersonal communication and teamwork.

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 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.
Good manufacturing practices.

Discovery and development of mdedicine.
Quality.
Preclinical safety.
Clinical efficacy and safety.

The European system and its operationalization:
EMA;
The functioning of the CHMP and several CXMP.
Centralized procedure;
National, decentralized and  mutual recognition procedure. 

The common technical document (CTD).
Some regulatoy aspects of biotechnologic medicines

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

Mandatory literature

EMA; EMA Scientifig guidelines
ICH; ICH guidelines

Complementary Bibliography

Abel Mesquita; Direito farmacêutico anotado. ISBN: 972-98579-2-X
António Celestino do Carmo Cavaco; A^construção da Europa do medicamento: um desafio do mercado único
José Aranda da Silva; Saúde pública, farmacêuticos e medicamentos. ISBN: 978-972-8610-60-9

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  by appointment.

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	55,00
Trabalho escrito	35,00
Prova oral	10,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	40,00
Frequência das aulas	40,00
Trabalho escrito	20,00
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% - written test + 35% - theoretical-practicalgroup work +  10% individual questions to the group elements. 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  not approved.