Managerial Aspects of BNCT at a Nuclear Research Reactor

BNCT requires the collaboration of specialists from different disciplines and often from different institutes in different countries and hence from different nationalities. BNCT is primarily the combination of nuclear technology and medicine. The fact tha

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32

Wolfgang A.G. Sauerwein and Ray Moss

Contents 32.1 Introduction ................................................................................................................

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32.2 Interdisciplinary Collaboration at a BNCT Facility ...............................................

534

32.3 The Nuclear Part ........................................................................................................

534

32.4 The Medical Part ........................................................................................................ 32.4.1 Radiotherapy .................................................................................................. 32.4.2 Medical Physics ............................................................................................. 32.4.3 Pharmacy ........................................................................................................ 32.4.4 Other Medical Disciplines .............................................................................

535 535 536 536 536

32.5 Radiation Protection ..................................................................................................

537

32.6 Regulatory Affairs and Licensing for a BNCT Facility ..........................................

537

32.7 Insurances ...................................................................................................................

538

32.8 Quality Assurance for BNCT ....................................................................................

538

32.9 International Standards for Quality Assurance in Radiotherapy ......................... 32.9.1 Standard Operating Procedures......................................................................

538 541

References ..............................................................................................................................

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W.A.G. Sauerwein (*) NCTeam, Department of Radiation Oncology, University Hospital Essen University Duisburg-Essen, D-45122 Essen, Germany e-mail: [email protected] R. Moss

Institute for Energy and Transport, Joint Research Centre, European Commission, westerduinweg 3, 1755 LE, Petten, The Netherlands e-mail: [email protected] W.A.G. Sauerwein et al. (eds.), Neutron Capture Therapy, DOI 10.1007/978-3-642-31334-9_32, © Springer-Verlag Berlin Heidelberg 2012

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32.1

W.A.G. Sauerwein and R. Moss

Introduction

Currently worldwide, BNCT when applied to patients still has to be seen as clinical research and hence has to fulfil and follow all legal and institutional requirements for this purpose, which may be different from one country to another. The principles, however, are internationally agreed, and when selecting partners for BNCT, it must be assured that everybody complies with the regulatory requirements. Furthermore, it has to be underlined that in BNCT the use of a non-conventional radiation beam will add a supplementary challenge for the regulatory authorities. The time needed to have a trial protocol accepted cannot be und