XII Foresight Training Course

Innovative medicine and research: ethical, legal and regulatory issues

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

Emerging technologies in genetics, pharmacogenetics, genomics, advanced therapies as weel as ICT applications represent today the most advanced tools incorporated in the drug discovery and research & development process used for producing the largest part of the innovative medicines.
Thus, regulation and guidance have to be continuously adapted and updated to guarantee clinical benefits, economic and health outcome improvements, as well as the respect of fundamental and patient rights.
Legal, ethical and regulatory issues of innovation in medicine and helthcare will be analysed within this workshop.


Friday 27 September 2019 - Agenda

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


Models of Governance for Innovation in Medicine and Health Research
Siobhán O’ Sullivan
Royal College of Surgeons – Ireland, Chair of the COE DH-BIO Drafting Group on the Strategic Action Plan for 2020-2025, Vice-chair of the European Group on Ethics in Science & New Technologies

SESSION I – Innovative medicine and research

Timo Minssen, Director, 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
CRID – University of Namur – Belgium, Coordinator of the EAHL “Data Protection law and policy WG”

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


SESSION II – Access to health care and innovation

Joaquin Cayon De Las Cuevas, University of Cantabria – Spain, Director of the Research Group on Health Law and Bioethics at IDIVAL

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

Machine Learning Systems applied to health data and systems
Fedele Bonifazi
Vice-President 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, Former Head of the Legal Service and Data Protection Officer at the European Medicines Agency

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, Representative at the European Network of HTA Agencies, and the European Medicines Agency

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

Enrico Bosone, SIARV President, Board of Directors Member, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus – Italy

Course Scientific Committee

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

Scientific Secretariat
Antonella Di Dio | 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

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€ 25,00

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