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FDA Effective Regulatory & Quality Subm...
Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments. Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceu...
August 3-4, 2017
Organizer: GlobalCompliancePanel
Location: Morrisville, NC
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Biosimilar from Development to Registra...
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes: Design and TPP Pre-clinical testing and comparability Clinical testing Analytical studies Stability of biosimilar products Why you should attend: The regulation of Biosimilars is very complex and the approach used by various regions differs. Professi...
August 3-4, 2017
Organizer: GlobalCompliancePanel
Location: Morrisville, NC
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Statistical Methods A Visual Approach 2017
An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information...
August 3-4, 2017
Organizer: GlobalCompliancePanel
Location: Morrisville, NC
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