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The Organisation for Professionals in Regulatory Affairs 39 th INTRODUCTORY COURSE

BACKGROUND INFORMATION

© The Organisation for Professionals in Regulatory Affairs 2017

Please note that all printed material contained in course handouts are, unless copyright is assigned elsewhere, the copyright of The Organisation for Professionals in Regulatory Affairs. Agreement must be reached with TOPRA before any part of this material is reproduced, abstracted, stored in a retrieval system or transmitted in any form by any means – that is, electronic, mechanical, photocopying, recording or otherwise. All EMA guidelines contained within are subject to EMA copyright and are reproduced here for educational purposes.

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