The Seminar courses aim to promote in depth knowledge and capacitation of students to have action in the great areas of regulatory sciences, but also to allow students to acquire new knowledge that accurately reflect the state of the art, that as suffered a significant evolution in the last years. By completing this course, the student will be able to: i) identify the core questions that currently define the strategy for regulatory sciences at the service of medicines and health products; ii) identify the current controversies and stakeholders, and; iii) to understand, conceive and develop a critical opinion concerning the aspects presented and discussed.
European Regulatory strategic role on the way to 2020; Adaptive path approaches to medicinal products evaluation; Early dialogue with regulators as boosters for drug development; Patients engagement in medicines evaluation; Patients Reported Outcomes (PROs); Orphan Drugs – an affordable public good?; Engaging Health Technologies Assessment and Payers in the lifecycle of medicinal products; Pre- and post-licensing data generation; Biosimilars and the extrapolation of indications; The Guideline on investigational ATMPs. Challenges and hurdles for drug development for the paediatric and geriatric population.