E-Submissions and Data Standards for FDA (eCTD, CDISC, HL7)

Instructor: Angela Bazigos
Product ID: 704529
  • Duration: 90 Min
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This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

Why Should You Attend:

Each FDA center has different guidelines and processes to follow in order to have a successful submission for the regulatory review of the medical product. The submission process for drugs, biologics and medical devices is rigorous and has specific timelines and standards to follow.

The agencies (FDA, EMEA) encourage electronic submissions and they have developed data standards and other guidelines. The Common Technical Document (CTD) describes the modules, sections and documents to be used by an Applicant for a Marketing Authorization for a medical product for human use ( EU, Japan and US). Different Standard Development Organizations (HL7, ISO, CDISC, ICH) work to produce and harmonize standards nationally and worldwide to improve regulatory submissions.

This webinar will provide the new and expected guidances on data standards and electronic submissions for drugs and medical products. It will explain what are the policies and the requirements for submissions and standards for drugs in US and globally and how it affects healthcare/drug industry to adopt them. All functional groups and professionals who have responsibility in the submissions and approval process for medical products and need to have an overview of the field should attend.

Areas Covered in the Webinar:

  • Quality and Product Data Standards
  • Study Data Standards Update
  • Approval Process for Drugs, Biologics and Devices
  • FDA Submission Requirements and Guidances
  • FDA Electronic Regulatory Submission and Gateway
  • e-Submissions, EMEA - EU and Globally
  • International Conference on Harmonization (ICH)
  • Electronic Common Technical Document (eCTD), ICH
  • FDA eCTD Guidance and Specifications
  • 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 Will Benefit:

  • Management (pharma, biotech)
  • Policy analysts
  • Government officers
  • Health IT managers and analysts
  • Research and development (pharmaceutical, academia)
  • Regulatory Affairs personnel
  • Quality assurance/quality control personnel
  • Auditors and inspectors
  • Entrepreneurs investors
  • Consultants
  • Regulators

Instructor Profile:

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. She has over 35 years of experience in the lifesciences industry spanning GLP, GCP, GMP, medical devices and 21 CFR 11 and has a patent aimed at speeding up software compliance.

Ms. Bazigos is a past president of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to pharma / biotech / medical device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the lifesciences industry.

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