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

Event Information
Product Format
Prerecorded Event
Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR
60 Minutes
Product Description

Data Standards and e-Submissions for FDA: Overview of Policies and Guidances

Each medical product 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 (US FDA, EU 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.

Get the past and expected guidance on data standards and electronic submissions for drugs and medical products with our expert Dr Kosta Makrodimitris. The conference will explain what are the policies and the requirements for submissions and standards for drugs in the US and how it affects healthcare/drug industry to adopt them.

All groups and professionals who are responsible for the submissions and approval process for medical products and need to have an overview of the field should attend. Here are the tools you’ll walk away with:

  • Reference documents at FDA
  • Policies and Guidance timeline

Here are few topics covered in the session:

  • Overview: Approval Process for Drugs, Biologics and Devices
  • Submission Requirements & Guidance, US-FDA
  • Electronic Regulatory Submission, US-FDA
  • Electronic Common Technical Document (eCTD), ICH
  • eCTD Guidance and Specifications, US-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)
  • Benefits and Challenges with Data Standards worldwide

Who should attend?

  • Medical Device Professionals
  • Health Information Managers, Executives
  • Management (Pharma, Devices, Biotech)
  • Policy analysts, Regulatory Affairs
  • Government officers
  • Data standards experts
  • Research and Development (Pharmaceuticals, Devices, Academia)
  • Quality assurance/quality control personnel
  • Auditors and inspectors
  • Entrepreneurs Investors

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About Our Speaker

Dr. Kosta Makrodimitris

Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Informatics Advisor, Author & Strategist. He is certified on EHR/PHR, Clinical Trials, Biotech/Drug Development, and trained in US FDA/DHHS laws, regulations (medical devices, foods, drugs, personalized medicine, health IT). He is involved as:

  • Advisor and participant (ONC/DHHS for Health IT, Standards & Interoperability Framework, Meaningful Use Stages/EHR, Federal Health Architecture, Health Information Exchanges-HIMSS, Health Level 7/ISO TC215 standards).
  • Executive director...   More Info
    More Events By The Speaker

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