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 – 10.00Registration
10.00 – 10.10Opening and welcome remarks:
Prof. Andrzej Górski 
10.10 – 10.30Experimental therapy: the EMA perspective
Dr. Marisa Papaluca, Senior Scientific Adviser, European Medicines Agency, London
10.30 – 10.40Discussion
10.40 – 11.00Compassionate 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 – 11.10Discussion 
11.10 – 11.30The 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 – 11.40Discussion 
11.40 – 12.00COFFEE BREAK 
12.00 – 12.20Access 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 – 12.30Discussion
12.30 – 12.50Access to experimental treatment in the court’s interpretation
Dr. Agata Wnukiewicz-Kozłowska, University of Wroclaw, Faculty of Law, Administration and Economics
12.50 – 13.00Discussion 
13.00 – 13.20Compassionate use and ethics committees
Dr. Jan Borysowski, Medical University of Warsaw 
13.20 – 13.30Discussion
13.30 – 14.00Summary and conclusions 
14.00 – 15.00LUNCH