Regulamentar Aspects of Bioactive Substances

Code:

QF13010

Acronym:

ARSB

Keywords
Classification	Keyword
CNAEF	Pharmaceutical Sciences

Instance: 2021/2022 - 2S

Active?	Yes
Course/CS Responsible:	MSc in Pharmaceutical Chemistry

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MQF	20	Official Curriculum	1	-	3	28	81

Teaching language

Suitable for English-speaking students

Objectives

It is intended that students acquire a set of knowledge on drug regulation
that allow:
to understand why medicines must be authorized and the design of the marketing authorization system,
the evaluation of the impact on the development and manufacturing process of new bioactive substances.

Learning outcomes and competences

Students will acquire the ability to interpret and apply the regulations regarding bioactive substances.
Prepare professionals with expertise in the area of regulatory aspects of drugs.

Working method

Presencial

Program

1. Regulatory framework in the area of medicines.

Key historical elements in the European and American.

The construction of a global system and ICH.

2. The regulatory system of the medicines in the European Union. Regulatory concepts of the Quality, Safety Preclinical, Clinical efficacy and safety.

The European system and coordination of regulatory authorities.

3. The contents of a dossier for approval of a medicine.

The general structure of the Common Technical Document (CTD).

Specific issues of quality in the preparation of the CTD.

The importance of DMF and / CEP in assessing the quality of the drug substance.

Development and validation of analytical procedure and manufacturing process for drug substance.

Stability of the drug substance 

 

 

Mandatory literature

EMA; Quality: Scientific Guidelines

Teaching methods and learning activities

Theoretical classes: essentially the expository and interrogative method, using PowerPoint presentations, where discussion and interaction with students are promoted. Theoretical-practical classes will be aimed at the elaboration, presentation and discussion of a work related to the syllabus contents of the theoretical classes, promoting the interrelation of knowledge and the critical spirit of the students.

 

Evaluation Type

Distributed evaluation with final exam

Assessment Components

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

Amount of time allocated to each course unit

designation	Time (hours)
Trabalho escrito	20,00
Estudo autónomo	33,00
Frequência das aulas	28,00
Total:	81,00

Eligibility for exams

Theoretical classes are not mandatory. Theoretical-practical classes follow the evaluation rules in force.

Calculation formula of final grade

Distributed evaluation with final exam

Formula Evaluation: The final grade is weighted as follows: 60% of the final exam + 40% 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.