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www.biopharminternational.com February 2020 BioPharm International eBook 2
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AUDIENCE DEVELOPMENT
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MJH LIFE SCIENCES
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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
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Joy Puzzo
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EDITORIAL
Editorial Director Rita Peters RPeters@mjhlifesciences.com
Senior Editor Agnes M. Shanley AShanley@mjhlifesciences.com
Managing Editor Susan Haigney SHaigney@mjhlifesciences.com
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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
www.biopharminternational.com March 2020 BioPharm International eBook 3
