ICH 8 (Group 1 Students)

ICH E10 Student Chapters (Group 2)

ICH E10 Student Chapter (Group 3)

Student presentation of the ICH E8 guideline and detailed interactive discussion with all students.

Student presentation of the first part of the ICH E10 guideline and detailed interactive discussion with all students.

Student presentation of the second part of the ICH E10 guideline and detailed interactive discussion with all students.

Informed consent

Explanation of the need for informed consent, explanation of its scope and methods of communication with the patient, taking into account its acquisition.

Ethical Aspects

Good Clinical Practices

Participatory approach and analysis of the ethical aspects of conducting clinical trials and their evolution throughout history. Presentation and discussion of current good clinical practices and their alignment with European guidelines.

Good Clinical Practices

Participatory approach and analysis of the ethical aspects of conducting clinical trials and their evolution throughout history. Presentation and discussion of current good clinical practices and their alignment with European guidelines.

Randomization

Explanation of the concept of randomization and its origin. Analysis of the advantages of the concept and its application. Analysis of different types of randomization over time.

Ethical aspects