3 Lessons From The GPhA’s Biosimilars Council Conference

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http://www.bioprocessonline.com/doc/biosimilar-lessons-from-the-ema-0001 Biosimilar Lessons From The EU - Suzette Kox, the senior director of the Biosimilars Medicines Group and chair of the biosimilars committee of the International Generic and...

http://www.bioprocessonline.com/doc/fda-s-new-compounded-drug-guidances-what-the-pharma-industry-needs-to-know-0001 FDA’s New Compounded Drug Guidances — What The Pharma Industry Needs To Know - As a member of the pharmaceutical industry, you might be thinking, “Why should I read an article about how the FDA is tackling problems at drug ...

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http://www.bioprocessonline.com/doc/a-risk-based-approach-to-environmental-monitoring-control-for-pharmaceutical-distribution-0001 A Risk-Based Approach To Environmental Monitoring Control For Pharmaceutical Distribution - Over the past few decades, many companies have spent time and capital investment in assessing and mitigating risk factors across the extended supply...

http://www.bioprocessonline.com/doc/single-use-continuous-manufacturing-the-new-paradigm-in-biopharmaceutical-processing-0001 Single-Use Continuous Manufacturing The New Paradigm In Biopharmaceutical Processing - Two significant trends in biopharmaceutical production are coming together. For years, single-use systems have been gaining traction as a way to make ...

http://www.bioprocessonline.com/doc/utility-system-design-considerations-for-single-use-bioprocessing-0001 Utility System Design Considerations For Single-Use Bioprocessing - Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic...

http://www.bioprocessonline.com/doc/for-u-s-biosimilar-success-look-beyond-borders-0001 For US Biosimilar Success Look Beyond Borders - In any industry, there are the experts who become known as the foremost voices of the industry. Biosimilar evangelist, Bert Liang, CEO of Pfenex and...

http://www.bioprocessonline.com/doc/quality-systems-basic-concepts-considerations-0001 Quality Systems 101 Basic Concepts Considerations - Whether you are a life science startup with a brick-and-mortar office or working as a virtual company, at some point the question comes up: Do we...

http://www.bioprocessonline.com/doc/tips-for-better-time-management-in-pharmaceutical-operations-0001 6 Tips For Better Time Management In Pharmaceutical Operations - We all want to maximize the productive use of our time, correct? Over the span of my pharmaceutical industry career, I have been fascinated with this ...

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http://www.bioprocessonline.com/doc/fda-emphasizes-regulatory-flexibility-in-biosimilar-reviews-0001 FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews - A study recently published in the BJCP go a long way toward providing a clear example of what regulatory flexibility looks like in the EMA. But where ...

http://www.bioprocessonline.com/doc/how-to-prepare-your-biosimilar-company-for-interchangeability-0001 How To Prepare Your Biosimilar Company For Interchangeability - While attending a recent biosimilars conference, I heard few clear opinions about whether interchangeability will be a beneficial strategy for...

http://www.bioprocessonline.com/doc/lessons-from-the-gpha-biosimilars-council-conference-0001 3 Lessons From The GPhA’s Biosimilars Council Conference - This inaugural conference touched upon many of the topics one would expect, including reimbursement, interchangeability, naming, the global markets,...

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