Clinical and Non-Clinical Research

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 evaluation methodology with 2 evaluation moments (50% Tand 50% TP).

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

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

NAO

• John Gallin J, Ognibene F, Johnson LL. Principles and Practice of Clinical Research, 4th ed. 2017, Academic Press
• 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)
• Regulamento (UE) 2017/745 do Parlamento Europeu e do Conselho, de 5 de abril de 2017, relativo aos dispositivosmédicos, que altera a Diretiva 2001/83/CE, o Regulamento (CE) n.° 178/2002 e o Regulamento (CE) n.° 1223/2009 e querevoga as Diretivas 90/385/CEE e 93/42/CEE do Conselho (Texto relevante para efeitos do EEE.)