Regulatory Affairs and Ethics of Clinical Research

1. Regulatory framework in Portugal and Europe
1.1. Medicinal products for human use
1.1.1. New European regulation on clinical trials
1.1.2. Clinical trials Information System (CTIS)
1.2. Medical devices
1.2.1. New European Medical Device Regulation
1.2.2. European database of Medical Devices (EUDAMED)
1.2.3. Normative references
2. Good Clinical Practice
2.1. Principles
2.2. Responsibilities of stakeholders
2.3. Ethical evaluation and risk-benefit determination of clinical trials/studies
3. Procedure for applying to competent authorities for approval
3.1. Clinical trial with medicinal product for human use
3.2. Clinical study with medical device
4. Preparation of regulatory documents
4.1. Experimental Medicine Dossier (IMPD)
4.2. Medical Device technical documentation
5. Post-Marketing Studies
5.1. Post-marketing authorisation studies
5.2. Post-Marketing Clinical Follow-Up
6. Regulatory and scientific advice process
7. Ethics in Clinical Research
7.1. Informed consent
7.2. Vulnerable populations
7.3. Insurance
7.4. Data protection
7.5. Compensation of volunteers and compensation for damage
7.6. Conflict of interest, fraud, misconduct
7.7. Biobanks as a resource in clinical research-regulatory and ethical framework

NAO