Teaching Methodologies
Teaching methodologies:
• Presentation of the syllabus in the form of workshop;
• Work with oral presentation;
• Discussion of topics;
The EVALUATION contemplates two methodologies:
1- Individual written work (IT);
2- Written assessment (AE).
The Final Grade (NF) is obtained by adding the components: NF = TI 50% + AE 50%
Learning Results
1. Framing the drug problem in the context of health at national and European level;
2. Identify the legislation that supports the drug circuit in Portugal;
3. Know the legal regime of the medicine and health products for human use;
4. Recognize the ethical and legal requirements inherent to the professional activity developed around the medication;
5. Framing patents on medicines in industrial property law
6. Framing pharmaceutical innovation in the context of public health development.
Program
1. Medicines and public health
2. Regulatory bases for medicinal products for human use in Portugal
3. Drug Safety Regulation
4. Pharmaceutical Patents and medicines
5. Global approach to drug innovation
Internship(s)
NAO
Bibliography
1. Legislação Portuguesa, Estatuto do Medicamento e legislação afim
2. Livros:
a. Paulo Pinheiro & Miguel Gorjão-Henriques. Direito do Medicamento. Editora Coimbra. 2009
b. Jeovanna Viana Alves. Ensaios Clínicos. Editora Coimbra. 2003
c. Diana Montenegro da Silveira. Responsabilidade Civil por Danos Causados por Medicamentos Defeituosos. Editora:Coimbra Editora. 2010.
d. Roberta Silva Melo Fernandes Remédio Marques. Patente Farmacêutica e Medicamento Genérico: A Tensão Jurídicaentre o Direito Exclusivo e a Livre Utilização. Editora : Juruá Editora; 1ª edição (16 setembro 2013). ISBN-13 : 978-853624429
3. Internet:
a. Autoridade Nacional do Medicamento e Produtos de Saúde, I. P./INFARMED:http://www.infarmed.pt/portal/page/portal/INFARMED
b. Agência Europeia de Medicamentos (EMA): http://www.ema.europa.eu/
c. European Commission/DG Health & Consumers/Public health. EudraLex: http://ec.europa.eu/d. Conferência Internacional de Harmonização (ICH): http://www.ich.org/