FACULDADE DE FARMÁCIA UNIVERSIDADE DE LISBOA

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1 FACULDADE DE FARMÁCIA UNIVERSIDADE DE LISBOA MASTER POST-GRADUATED SPECIALIZATION COURSE Regulation and Evaluation of Medicines and Health Products 9 th Edition 2016/2018 The Post-Graduated Specialization Course in Regulation and Evaluation of Medicines and Health Products corresponds to the curricular year 1 of the Master Regulation and Evaluation of Medicines and Health Products. Afterwards, it is possible for the student to continue the studies, through the preparation of a Master dissertation. The 2-year Master study cycle in Regulation and Evaluation of Medicines and Health Products is organized in 4 semesters (120 ECTS). General Objectives: This course aims to increase de knowledge on all the regulatory aspects, laws and directives, science based approaches on the Marketing authorization in European Union for Medicinal Human Medicines and Veterinary Medicines. Furthermore, this course will include legislation in Health Products based on Medicinal Plants as well as patent laws,

2 price regulation and others. This course will also guarantee the training of professionals that can work and solve complex issues in regulatory affairs, regulatory science and translational research and can contribute to optimize decision making process. Course Duration: The Master Course takes two academic years, divided into four semesters, starting in September Degree Requirements: Master or BSc degree with diverse background, in areas of Pharmaceutical Sciences, Health Sciences, or with adequate curriculum vitae. Deadlines: Applications July 4 to September 05, 2016 Results September 9 Registration September 12 through 15 Beginning September 30 Application: The application form and further instructions are available at Selection Criteria: Applicants will be selected by the Scientific Committee based on: i) classification of the academic degree, and adequateness to the program; and ii) curriculum vitae. An interview will be undertaken if needed. Maximum 40 students will be selected. Tuition: The Master Course tuition fee for the national and international students is 5.500,00 ( 4.500,00 on the 1 st year and 1.000,00 on the 2 nd year). Application Fee - 75 Euros Registration Fee - 75 Euros Student Insurance Fee - To be fixed

3 Schedule: The Course runs on Friday, after and Saturday from until Classes will be at the Faculdade de Farmácia. Coordinator: Beatriz Silva Lima, Coocordinator Ana Paula Martins Executive Comission: Professora Doutora Beatriz Silva Lima (FFULisboa) Professora Doutora Ana Paula Martins (FFULisboa) Professor Doutor Rogério Sá Gaspar (FFULisboa) Professor Doutor António José Almeida (FFULisboa) Professor Rui dos Santos Ivo (FFULisboa) Consulting Board from Exacutive Comission: INFARMED Prof. Henrique Luz Rodrigues (Presidente) APIFARMA Dr Heitor Costa (Diretor-Executivo) APOGEN Dr Paulo Lilaia (Presidente) APORMED Dr Humberto Costa (Secretário-Geral) Colégio de Registos e Regulamentação da Ordem dos Farmacêuticos (OF) Drª Antonieta Lucas (Presidente) APREFAR Drª Paula Sanches (Presidente) Scientific Comission: Professor Doutor José Augusto Guimarães Morais (FFULisboa, Coordenador do Conselho Científico) Prof. Doutora Ana Paula Martins (FFULisboa) Prof Doutor António José Almeida (FFULisboa) Profª Doutora Beatriz Silva Lima (FFULisboa) Prof Doutor Bruno Sepodes (FFULisboa) Profª Doutora Helena Margarida Ribeiro (FFULisboa) Prof Doutor João Gonçalves (FFULisboa) Dr. José António Aranda da Silva Prof Doutor José Cabrita (FFULisboa) Profª Doutora Leonor Meisel (FFULisboa)

4 Prof. Doutor Luís Lopes Madureira Silva Miguel (FFULisboa) Profª Doutora Luisa Papoila (FFULisboa) Profª Doutora Mafalda Videira (FFULisboa) Prof Doutor Manuel Caneira da Silva (FFULisboa/FMUL) Profª Doutora Maria Augusta Soares (FFULisboa) Profª Doutora Maria Henriques Ribeiro (FFULisboa) Profª Doutora Maria do Rosário Lobato (FFULisboa) Prof. Doutor Rogério Sá Gaspar (FFULisboa) Prof Rui Santos Ivo (FFULisboa) Study Plan: Curricular Units Semester ECTS Introduction to Medicines Regulation 1 6 Medicine Quality I 1 6 Politics and Economics of Medicine 1 6 Medicine Quality II 1 7 Veterinary Medicines 1 5 Clinical Trials 1 7 Option I 1 4 Industrial Organization and Patents 2 2 Health Products 2 2 Seminars I 2 2 Pharmacotoxicology 2 7 Seminars II 2 2 Option II 2 4 TOTAL 60 Optional Curricular Units Semester ECTS Pharmacoeconomics (OP I)* 1 4 Pharmacoepidemiology (OP I)* 1 4 Applied Biostatistics (OP I)* 1 4 Medicinal of Biotechnology (OP II)* 2 4 Pharmacokinetics in Drug Development (OP II)** 2 4 Pharmacovigilance (OP II)** 2 4 TOTAL 8 * The optional curricular units selected by more students will be given in each year. Scientific Dissertation 3 and 4 60 Total 120

5 Information and Secretariat: NPGA - Núcleo de Planeamento e Gestão Académica Apoio aos Cursos Pós-Graduados posgraduados@ff.ulisboa.pt Faculdade de Farmácia da Universidade de Lisboa. Av. Prof. Gama Pinto, Lisboa Tel Fax: