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21 CFR Part 11: Gap Analysis, Remediation & Adding Value to Validation $249.00 Jeffrey Gassman		505(b)(2) Submissions: Eligibility, Strategies & Preparation $249.00 Howard Hubbell		Achieving Global Registration of Complex Biosimilars $249.00 Robert Blakie
Alliance Management - Narrowing the Divide Between Drugs and Diagnostics $249.00 David Kern		An Overview of EMEA & Centralized Procedure $249.00 Ulrich Granzer		ANDA vs. 505(b)(2): When and Why? $249.00 Joel Falk & Nick Fleischer
Beyond Using SharePoint to Manage Regulatory Documents $249.00 John Postle & Kent Fernald		Building Better Clinician Relationships $249.00 Clair Callan		Cloud Computing for the FDA-Regulated Company $249.00 John English
Companion Diagnostics - What Pharma Needs to Know About IVDs $249.00 David Kern		Complying with EMA's New Mandatory Requirements for Medicinal Product Information (EVMPD) $249.00 Andrew Marr		Dealing with Counterfeit and Substandard Pharmaceuticals $249.00 Albert Wertheimer
Design and Regulatory Considerations in Anti-Infective Drug Development $249.00 John Powers & Carl Kraus		Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway $249.00 Greg Onyszchuk		e-Consent: An Idea Whose Time Has Come $249.00 Susan Brink & Jovianna DiCarlo

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