XII Foresight Training Course

Innovative medicine and research: ethical, legal and regulatory issues

Hotel Dieu St Jacques
2 rue de la Viguerie
Toulouse, Francia

Change in Regulatory Sciences is a continuous challenging process! The challenge is to align scientific and patients’ objectives with regulatory requirements along the whole development process of health products. Moreover, all the stakeholders should be aware of the criteria by which the authorisation and access to products will be measured and decided to cover patients’ specific needs. To ensure such an alignment, it is time to moving from a reactive regulation to a proactive involvement of all the involved parties, including users as well as producers. This course is aimed at involving and networking people to properly understand the many novelties of the EU system and contributing to their implementation to anticipate good medicines and other products for human health and wellbeing on the market. The present Course will discuss the EU Pharmaceutical System novelties, with special focuses on three main topics. In addition, an initiative to set up a Regulatory Network will be presented.

27 Settembre 2019 - Agenda

Welcome speeches
Ceci, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus (Italy)
Annagrazia Altavilla, European Association of Health Law (France)
Laurence Lwoff, Head of the Bioethics Unit – Human Rights Directory – Council of Europe (France)


Models of Governance for Innovation in Medicine and Health Research
Siobhán O’ Sullivan, Royal College of Surgeons (Ireland)

SESSION I – Innovative medicine and research

Timo Minssen, Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenaghen – Denmark

Access to Personal Data for Scientific Research in the perspective of innovative medicines
Jean Herveg, University of Namur (Belgium)

Legal and Regulatory issues dealing with paediatric specificity in the EPTRI (European Paediatric Translational Research) framework
Olga Tzortzatou, Biomedical Research Foundation of the Academy of Athens (Greece)

Intellectual Property Protection of Genetic Material and Information in the Pharmaceutical Sector? – Legal Questions on Genetic Material and Genome Sequencing between Innovation, Protection and Sharing
Claudia Seitz,
University of Basel (Switzerland), University of Bonn’s Centre for the Law of Life Sciences (Germany)


SESSION II – Access to health care and innovation

Joaquin Cayon De Las Cuevas, University of Cantabria (Spain)

Health Technology Assessment (HTA) and access policies
Verena Stühlinger, University for Health Sciences, Medical Informatics and Technology (UMIT) – (Austria)

Machine Learning Systems applied to health data
Fedele Bonifazi, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus (Italy)

Exploring solutions to foster ATMP’s development and access to patients in Europe
Vincenzo Salvatore, University of Insubria (Italy)

SESSION III – Empowerment and patients’ rights in innovative healthcare

Tom Goffin, Ghent University (Belgium)

Orphan medicinal products and health budgets: our role as patient advocates
François Houyez, EURORDIS (France)

Health vulnerability and the European framework on access to orphan medicines
Eloise Gennet, INSERM UMR 1027, University of Toulouse (France)

Discussion and conclusion

Enrico Bosone, SIARV (Italy)

Annagrazia Altavilla, Espace Ethique PACA-Corse/AP-HM, European Association of Health Law (France)

Lista dei relatori

Scarica la lista dei relatori.

Scientific Committee

Annagrazia Altavilla | European Association of Health Law
Fedele Bonifazi | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

Scientific Secretary
Antonella Didio | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

Organised by

Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

European Association of Health Law

Espace éthique


Sto caricando la mappa ....


Bookings are closed for this event.

icalUrl: - icalLink: iCal - webCalUrl: webcal:// - webCalLink: webcal - gCalUrl: - gCalLink: 0

Pin It on Pinterest

Share This