COURSE OBJECTIVES
Research Ethics
To provide students with an overview of the main ethical and legal issues related to scientific research, access to data and data sharing. The Research Ethics course is designed in a highly innovative manner, with the goal of fostering an ethical attitude in the relationship with the patients and/or the lab animals (research ethics and animal ethics) and with the colleagues (research integrity).

Regulatory Aspects
Introduction to the key features relating to the regulatory legislation and the Good Clinical Practices (GCP) principles.

Statistical Aspects
To understand the different types of studies in clinical research: a translational approach from pre-clinical to clinical research.

TOPICS
Research Ethics
Fundamental ethics principles in research; Data governance and regulatory landscape (GDPR); issues and models related to data access / data sharing – 4h Luca Marelli
The Ethics and Law of Experiments on Animals; End of life issues and the rights of terminally ill patients – 2h Silvia Salardi
The role of Ethical Committees – 2h Maddalena Lettino

Regulatory Aspects
Regulatory aspects & legislations: the view of AIFA – 2h Sandra Petraglia
Regulatory aspects & legislations: the view of pharma – 2h Maria Elena Trovati
Regulatory aspects & legislations in the area of rare-diseases – 2h Annabella Amatulli
Good clinical practices – 2h Silvia Mori

Statistical Aspects
Design of RCTs – 4h Maria Grazia Valsecchi
Pre-clinical study design – 4h Luca Porcu
Early phase study design – 4h Stefania Galimberti
Biomarker based designs – 4h Andrea Callegaro
Sample Size Calculation – 4h Davide Bernasconi
Omics designs – 4h Stefano Calza
Adaptive designs – 4h Federico Rotolo
Estimands – 2h Stefano Vezzoli
Real world (pharmaceutical) – 2h Francesca Mastromauro
Bayesian designs – 4h Paola Berchialla
Study PASS (Post Authorization Safety Study) and PAES (Post Authorization Efficacy Study) – 4h Domenico Criscuolo