INTERNATIONAL CONFERENCE“Medical, ethical and legal aspects of experimental therapy”
Warsaw, 19 May 2017 P R O G R A M M E
09.30 – 10.00
Registration
10.00 – 10.10
Opening and welcome remarks: Prof. Andrzej Górski
10.10 – 10.30
Experimental therapy: the EMA perspective Dr. Marisa Papaluca, Senior Scientific Adviser, European Medicines Agency, London
10.30 – 10.40
Discussion
10.40 – 11.00
Compassionate Use in the United States: An Update of Recent Industry, Regulatory, Legislative, and Social Factors Dr. Alison Bateman-House, Division of Medical Ethics, NYU School of Medicine, Co-Chair, Working Group on Compassionate Use and Pre-Approval Access, Deputy Director, Compassionate Use Advisory Committee (CompAC)
11.00 – 11.10
Discussion
11.10 – 11.30
The ethics of emergency use of unproveninterventions outside of research” – WHO’s guidance Dr. Abha Saxena, Coordinator, HQ/HIS/IER/REK, World Health Organization, Geneva
11.30 – 11.40
Discussion
11.40 – 12.00
COFFEE BREAK
12.00 – 12.20
Access to investigational drugs outside of controlled clinical research – individual and social interests Dr. Joanna Różyńska, University of Warsaw, Center for Bioethics and Biolaw
12.20 – 12.30
Discussion
12.30 – 12.50
Access to experimental treatment in the court’s interpretation Dr. Agata Wnukiewicz-Kozłowska, University of Wroclaw, Faculty of Law, Administration and Economics
12.50 – 13.00
Discussion
13.00 – 13.20
Compassionate use and ethics committees Dr. Jan Borysowski, Medical University of Warsaw