Open AccessWhite Paper on How to Go Forward with Cell-Based Advanced Therapies in Europe
Author(s) -
Reinhold G. Erben,
Beatriz SilvaLima,
Ilona Reischl,
Gustav Steinhoff,
Gudrun Tiedemann,
Wilfried Dalemans,
Antonie Vos,
Rob T.A. Janssen,
Katarina Le Blanc,
Gerjo J.V.M. van Osch,
Frank P. Luyten
Publication year - 2014
Publication title -
tissue engineering. part a
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.964
H-Index - 111
eISSN - 1937-335X
pISSN - 1937-3341
DOI - 10.1089/ten.tea.2013.0589
Subject(s) - white paper , reimbursement , summit , european union , product (mathematics) , harmonization , clinical trial , biosimilar , medicine , business , political science , health care , pathology , international trade , geometry , acoustics , law , geography , physics , mathematics , physical geography
The current White paper summarizes the discussions and exchange of experiences during the first European Interdisciplinary Summit on Cell-Based ATMPs held in Vienna, Austria, May 02-03, 2013. The meeting was supported by the Research Networking Programme REMEDIC (regenerative medicine) funded by the European Science Foundation and by the British Medical Research Council. To improve the competitiveness of Europe in the field of cell-based Advanced Medicinal Therapy Products (ATMPs), the following key issues were identified during the meeting: removal of national hurdles in the European Union, harmonization of national and subnational differences in Hospital Exemption rules, improved treatment algorithms for reimbursement, better knowledge on the mode of action, predictive preclinical efficacy and safety testing, need for innovative systems for preclinical testing, appropriate product characterization, manufacturing with cost of goods in mind, and appropriate design of clinical trials.