Pharmaceuticals

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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	7 Critical FDA Expectations of Senior Management $249.00 John Avellanet
A Common Sense Approach to FDA and ISO Compliance $249.00 Susan Soderholm	Academic Medical Centers and Clinical Research Productivity: How to Choose The Best Sites $249.00 Anita Kablinger	Achieving Global Registration of Complex Biosimilars $249.00 Robert Blakie
Adapting Project Risk Mitigation and Prevention Tools in Real-Life Trials $199.00 Susan Schenk	Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study $249.00 Michael Rosenberg	Adaptive Trial Design: Streamlining the Clinical Supply Process $249.00 Geert Langendries
Alliance Management - Narrowing the Divide Between Drugs and Diagnostics $249.00 David Kern	An Integrated Approach to Managing Supply Chain Risk $249.00 James Bird & Andrew Tait	An Overview of EMEA & Centralized Procedure $249.00 Ulrich Granzer
An Overview of Recent Risk-based Monitoring Guidance from the FDA $249.00 Joy Frestedt	ANDA vs. 505(b)(2): When and Why? $249.00 Joel Falk & Nick Fleischer	Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World $249.00 Edgar Adams & Robin Carter