Before preparing a medical product regulatory submission, you need to know the relevant requirements to ensure that your submission will comply. Did you know that each FDA center has different guidelines and processes for submission and regulatory review? Plus, the submission process for drugs, biologics and medical devices is rigorous – with specific timelines and standards.
Consider the following: Agencies (FDA, EMEA) encourage electronic submissions, and have developed data standards and guidelines that you can’t afford to ignore. And if you want to sell a medical product for human use in EU, Japan or the U.S., you should know how to use the Common Technical Document (CTD) – which describes the modules, sections and documents to be used for marketing authorization in these countries. Similarly, you should know about the requirements of different standard development organizations – such as HL7, ISO, CDISC, ICH – that work to produce, harmonize, and improve standards nationally and globally.
In this information-packed session with industry veteran Angela Bazigos, you will learn the new and expected guidance on data standards and electronic submissions for drugs and medical products. Bazigos will explain the policies that affect you, and walk you through the submission requirements and standards for drugs – in the U.S. and globally. You will also learn how these standards affect the healthcare/drug industry, how to adopt them, and more.
This webinar is a must for all functional groups and professionals who are responsible for regulatory medical product submissions and approvals.
Here’s a taste of what you will uncover in this instructive session:
Who Should Attend
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...
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