The Evolving Regulatory Landscape for Personalised Medicine in the EU

Course description

The Summer School ‘The Evolving Regulatory Landscape for Personalised Medicine in the EU’, planned as part of the Jean Monnet Module PERSONA – Law for personalising medicine in the EU (Grant Agreement 101240301), aims to provide a systematic understanding of the regulatory landscape for personalized medicine in the EU, develop robust problem-solving skills, and promote constructive dialogue between academia, professionals, and competent authorities. The 40-hour training initiative addresses European pharmaceutical legislation and its ongoing reform at the EU Council, the Medical Devices Regulation (MDR) and its prospects for revision, and the duties and responsibilities of stakeholders across the PM value chain.

Course target

The main target audience for the Course includes academic researchers (including doctoral researchers), healthcare professionals, entrepreneurs, employees of notified bodies, lawyers and legal counsel, and civil servants. The course will develop specialist skills that enable participants to take on leadership roles in developing innovative legal and policy approaches to medical technologies and implementing personalised medicine strategies that comply with the European legal framework.

Training objectives

The Summer School aims to familiarise participants with European pharmaceutical legislation, the Medical Devices Regulation (MDR), and the liabilities of stakeholders relevant to the value chain of personalised medicine. The teaching methodology alternates between lectures delivered by experts from different European legal systems (lawyers, doctors, regulatory experts) and interactive small-group tutorials, promoting constructive dialogue among academia, professionals, and competent authorities.

Teaching methods 

Lectures, Problem-Based Learning (tutorials, workshops)

The teaching methodology combines lectures given by experts from different European legal systems (lawyers, doctors, regulatory experts) and interactive tutorials in small groups, promoting constructive dialogue between academia, professionals and competent authorities. 

At the end of the Course, there will be a final assessment.

Course programme 

The Course programme, lasting 5 days, is structured as follows:

• Day 1 – Medicinal products

• Day 2 – Medical devices

• Day 3 – Clinical perspectives 

• Day 4 – Comparative perspectives

• Day 5 – Synthesis and assessment

Attendance certificate 

At the end of the Course, those who have attended at least 80% of the lessons, successfully passed the final assessment and are up to date with their enrolment fee payments will receive a certificate of attendance from the Sant'Anna School of Advanced Studies, valid within the limits permitted by law.