2018 Update and Guidance on Data Standards and e-Submissions for Drugs and Medical Products

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Sep 25, 2018
90 minutes
Product Description

Medical Product Regulatory Submissions – How to Do it the Right Way

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.

Session Highlights

Here’s a taste of what you will uncover in this instructive session:

  • Quality and product data standards
  • Study data standards update
  • Approval process for drugs, biologics and devices
  • Submission requirements and guidance, FDA
  • Electronic regulatory submission & gateway, FDA
  • E-submissions, EMEA, EU and globally
  • International Conference on Harmonization (ICH)
  • Electronic Common Technical Document (eCTD), ICH
  • eCTD guidance and specifications, FDA
  • Health level 7 regulated clinical research information management
  • Clinical data interchange standards consortium, (SDTM, SEND, ADAM)
  • Biomedical research integrated domain group (NIH, FDA, CDISC, HL7)
  • Top 10 issues with data

Who Should Attend

  • General managers
  • QA/QC managers
  • CAPA managers
  • Compliance officer
  • Quality engineers
  • Facility maintenance
  • Operations manager
  • Management representative
  • Internal auditors
  • Any other team member from the quality, and operations departments wishing to understand cleanroom environment


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About Our Speaker

Angela Bazigos - Pharma Conferences

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,...   More Info
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