BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

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2 BioPharm International eBook October 2021 © 2021 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may be reproduced or transmitted 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 fax 978-646-8700 or visit online. For uses beyond those listed above, please direct your written request to with "Permissions" in the subject line. Reprints: Contact Michael Tracey, MultiMedia Pharma Sciences LLC provides certain customer contact data (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 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 Senior Vice President, Industry Sciences Michael Tessalone 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 Chief Marketing Officer Michael Baer Executive Vice President, Global Medical Affairs and Corporate Development Joe Petroziello Senior Vice President, Content Silas Inman Senior Vice President, Operations Michael Ball Vice President, Human Resources & Administration Shari Lundenberg Vice President, Mergers & Acquisitions Chris Hennessy Executive Creative Director, Creative Services Jeff Brown EDITORIAL Editorial Director Chris Spivey Senior Editor Meg Rivers Managing Editor Susan Haigney European Editor Felicity Thomas Science Editor Feliza Mirasol Manufacturing Editor Jennifer Markarian Assistant Editor Grant Playter Creative Director, Publishing Melissa Feinen Senior Art Director Gwendolyn Salas Senior Graphic Designer Maria Reyes 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: magele-picture - Contents Regulatory Sourcebook October 2021 INNOVATION Collecting Industry's Thoughts on FDA FARS Report Feliza Mirasol 4 DRUG SAFETY The Real Danger of Substandard and Counterfeit COVID-19 Vaccines Meg Rivers 6 Serialization and Aggregation from a Manufacturing Perspective Meg Rivers 10 BIOSIMILARS The Evolving Biosimilar Approach Felicity Thomas 14 CMC STRATEGIES Selecting the Right CMC Strategy for Biologics Khanh Ngo Courtney 18 DATA INTEGRITY How Artificial Intelligence Impacts the Global Regulatory Environment Rajesh Talpade 22 BIOBUSINESS NIST Proposes Clarifications to Bayh-Dole March-in Rights Regulations Kevin E. Noonan 26 INDUSTRY PERSPECTIVES Industry Organizations Assist Pharma During the Pandemic and Beyond The Editors of BioPharm International 30 AD INDEX 33 C H A I R M A N & F O U N D E R Mike Hennexssy, Sr.

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