Features
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QA/QC
FDA & OTC Antiseptics
A review of consumer antiseptic wash ingredients undergoing FDA challengeDerek J. Prince, Herbert N. Prince & Daniel L. Prince, Gibraltar Laboratories 09.06.17
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Going All In: Drivers for Insourcing Professional Scientific Services
As the industry comes under increasing time and cost pressures, insourcing laboratory services continues to grow.Patricia Grace, Eurofins BioPharma Product Testing 09.06.17
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Dissolution is King
Despite the focus on CAPA, dissolution testing deserves closer attention and a stronger emphasis.Keith Moore, Metrics Contract Services 09.06.17
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GMPs/GCPs
The Importance of GMP, GLP and GCP in the Safe Development of Viral Challenge Agents
Developing new challenge agents faster and at a lower cost.Adrian Wildfire, Clinical Research 09.06.17
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Regulatory Affairs | Serialization
The DSCSA Delay What Does it Mean for the Pharma Industry?
What should companies be doing to implement a suitable serialization solution before the new enforcement date arrives?Erik Haeffler, Recipharm 09.06.17
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Regulatory Affairs
Data Integrity: A Practical and Risk-Based Approach
Ways an organization can form a culture and cost-effective means to meet the various challenges in sustaining data integrity.Robert Marohn, ClinLogic 09.06.17
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Regulatory Affairs | Serialization
The Psychology of DSCSA: Four Stages of Serialization
It’s time for manufacturers to adopt post-serialization efficiencies.Larry Hotz, Marketing Manager, WDPrx - Woodfield Pharmaceutical LLC 09.06.17
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Regulatory Affairs | Serialization
Fighting Back!
The drug industry takes a bare-knuckle approach to drug counterfeiters.Daniela Geiger, Vetter 09.06.17
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Cold Chain Management
Cold Chain Market and Technology Trends
Advanced technologies for cold chain management to ensure drug safety and efficacy continue to grow in importance.Mark Sawicki, Cryoport 09.06.17
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Streamlining Operations: Sponsor-CRO Partnership Trends
Clinical teams have the opportunity to shed decades-old siloed operating model.Jim Reilly, Veeva Systems 09.06.17
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Outsourcing Partnerships: Trends in the CDMO Sector
The market for outsourcing services is growing faster than the pharmaceutical industry as a whole.Tim Wright, Contract Pharma 09.06.17
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How Can We Predict Immunogenicity Earlier in Drug Discovery?
Scientists can make better-informed decisions and identify potential immune responses earlier by giving virtual and real expKevin Merlo and Tim Moran, Dassault Systèmes Biovia 09.01.17
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Regulatory Affairs | Serialization
Serialization Validation: Right Fitting Your Strategy With a CMO
There are three key factors for manufacturers to evaluate as they define and refine their validation and testing approach.Linda Kristoffersen and David Colombo, KPMG Life Science Advisors 09.01.17
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Social Responsibility in Action
Transformation of strategic partnerships between CROs and sponsorsAndrew MacGarvey, CEO, CROS NT 06.06.17
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APIs
Optimizing the API Life Cycle Through Innovation
Bringing down API costs through new technologies and customer collaborationJonathan Knight, VP New Product Development, Cambrex 06.06.17
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Regulatory Affairs | Serialization
The EU FMD
Regulatory requirements and key considerations for implementationBrian Daleiden and Caitlin Czulada, VP of Industry Marketing, TraceLink and Manager, Technical Services, TraceLink 06.06.17
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Regulatory Affairs | Serialization
Lessons Learned From Global Serialization
A look at some key findings leading up to Europe’s 2019 FMDCarlos Machado, Serialization Director, SEA Vision U.S. 06.06.17
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Regulatory Affairs | Serialization
Adapt Or Die
Contract packaging operations at the center of transition to serializationLarry Hotz 06.06.17
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Regulatory Affairs | Serialization
The Standards Heard Round the World: DSCSA Legislation and the Global Supply Chain
The more industry members learn from and communicate with each other, the more all of us can anticipate success in implementiHeather Zenk, Vice President, Global Secure Supply Chain Operations, AmerisourceBergen 06.06.17
