Base Knowledge
Not applicable
Teaching Methodologies
The teaching methodology is adapted to 1T/1TP class distribution with expository session and seminars, recurringwhenever possible to the critical analysis of case-studies. The theoretical contents will be used in TP component in theelaboration of projects. The CU is assessed with a discreet methodology with 1 written evaluation T (30%) and 2 evaluation moments TP (Case-study 20% + Project 50%).
Learning Results
At the end of the Curricular Unit, the student must be able to:
1. Describe the legal and regulatory framework for research new medicines and medical devices
2. Discuss ethical issues in clinical research.
3. Recognize the principles of Good Clinical Practice
4. Recognize the characteristics of non-clinical and clinical development plans for new medicines and medical devices
5. Recognize the different types of non-clinical and clinical studies of medicines and medical devices
6. Identify the structure and contents of the main documents used in the implementation of clinical studies
Program
1. Research of new medicines and medical devices
1.1. Regulatory environment for clinical research
1.2. Ethics in clinical research
1.3. Good Clinical Practices
2. Introduction to the non-clinical and clinical development plan for new medicines and medical devices
3. Non-clinical development of new medicines
3.1. Pharmacodynamic studies
3.2. Safety pharmacology studies
3.3. Toxicology studies
3.4. Pharmacokinetics and toxicokinetic studies
4. Clinical development of new medicines
4.1. Human Pharmacology studies (Phase I)
4.2. Exploratory studies (Phase IIA and IIB)
4.3. Confirmatory studies (Phase IIIA and Phase IIIB)
4.4. Post-approval studies (Phase IV)
5. Non-clinical and clinical development plan for Medical Devices
5.1. Biocompatibility studies
5.2. Pilot and pivotal clinical studies
6. Essential documents from clinical studies
6.1. Investigator brochure
6.2. Clinical Trial protocol
6.3. Informed consent
Grading Methods
Discrete Assessment: 30% T (written exam) + 70% TP (20% Ethical Study Case + 50% Project presentation - Analysis of a clinical trial protocol and informed consent)
Final Assessment: Written exam (30% T + 70% TP)
Internship(s)
NAO
Bibliography
• John Gallin J, Ognibene F, Johnson LL. Principles and Practice of Clinical Research, 4th ed. 2017, Academic Press
• Clinical research Law n.º 21/2014 (Diário da República, Lei nº 21/2014 – Lei da Investigação Clínica).
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), E6(R2)– Good Clinical Practice (GCP), 2016
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), E8(R2)– Revision on General Considerations for Clinical Studies, (draft 2019)
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)Text with EEA relevance