BioPharm International - March2020

BioPharm International - Regulatory

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Name of supplement chapter name February 2020 BioPharm International eBook 2 BioPharm I N T E R N AT I O N A L eBook T h e S ci e n ce & B usi n e ss o f B i o p h a r m a ce u t i c a ls Cover: Coloures-Pic - © 2020 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may be reproduced or transmit ted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal /educational or personal use of specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fa x 978- 6 46-8700 or visit ht tp://w w online. For uses beyond those listed above, please direct your writ ten request to Permission Dept. Alexa Rockenstein, arockenstein@mjhlifesciences. com. Reprints: Contact Michael Tracey, MultiMedia Pharma Sciences LLC provides cer t ain customer cont ac t dat a (such as customers' names, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want MultiMedia Pharma Sciences LLC to make your contact information available to third parties for marketing purposes, simply email mmhinfo@mjhlifesciences and a customer service representative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. BioPharm International does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. BioPharm International welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. To subscribe, email ADVERTISING Publisher Mike Tracey National Sales Manager Scott Vail European Sales Manager Linda Hewitt European Senior Sales Executive Stephen Cleland VP/Managing Director, Pharm/Science Group Dave Esola C.A.S.T. Data and List Information Michael Kushner AUDIENCE DEVELOPMENT Audience Development Christine Shappell MJH LIFE SCIENCES TM Chairman and Founder Mike Hennessy, Sr Vice Chairman Jack Lepping President and CEO Mike Hennessy, Jr Chief Financial Officer Neil Glasser, CPA/CFE Executive Vice President, Operations Tom Tolvé Senior Vice President, Content Silas Inman Senior Vice President, I.T. & Enterprise Systems John Moricone Senior Vice President, Audience Generation & Product Fulfillment Joy Puzzo Vice President, Human Resources & Administration Shari Lundenberg Vice President, Business Intelligence Chris Hennessy Vice President, Corporate Branding & B2B Marketing Amy Erdman Executive Creative Director, Creative Services Jeff Brown EDITORIAL Editorial Director Rita Peters Senior Editor Agnes M. Shanley Managing Editor Susan Haigney European Editor Felicity Thomas Science Editor Feliza Mirasol Manufacturing Editor Jennifer Markarian Assistant Editor Lauren Lavelle Senior Art Director Marie Maresco Graphic Designer Maria Reyes REGULATORY UPDATE Is There a "New Normal" for Drug Quality? Rita Peters 4 DATA INTEGRITY ALCOA+ and Data Integrity Susan J. Schniepp 6 GENE AND CELL THERAPIES Inside FDA's New Gene and Cell Therapy Guidance Agnes Shanley 8 PHARMACOPOEIA COMPLIANCE SERIES Monograph Development: Why and When to Participate J. Mark Wiggins and Joseph A. Albanese 12 A Practical Approach to Pharmacopoeia Compliance J. Mark Wiggins and Joseph A. Albanese 26 Pharmacopoeia Compliance: Putting it All Together; What Is on the Horizon J. Mark Wiggins and Joseph A. Albanese 36 RESOURCES Regulatory and Standard Setting Organizations 47 Resources, Guidelines, and Guidance Documents 51 Ad Index 52 Regulatory Sourcebook March 2020 Contents March 2020 BioPharm International eBook 3

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