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e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7) - Webinar By GlobalCompliancePanel

  April 18, 2013  

GlobalCompliancePanel, Online Training

Overview: 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. 

Why Should You Attend: This webinar will provide the new and expected guidances on data standards and electronic submissions for drugs and medical products. We 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 Session:
  • Overview: Approval Process for Drugs, Biologics and Devices
  • Submission Requirements & Guidances, 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)
  • Benefits and Challenges with Data Standards worldwide

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

Price: $225.00


Organized by: GlobalCompliancePanel
Invited Speakers:
Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Informatics Advisor, Author & Strategist. Dr. Makrodimitris is the principal for K Makrodimitris that specializes in Health IT & BIO business development, eHealth education, Health Information policy. He is certified on EHR/PHR, Clinical Trials, Biotech/Drug Development, and trained in US FDA/DHHS laws, regulations (devices, foods, drugs, personalized health). He is involved as, Medical Devices Committee Member, Writer at The Food and Drug Law Institute, Consultant (Health Informatics/Policies/Standards) at DHHS/ONC, Standards & Interoperability Health Information Management Systems Society, Health Level 7(EHR, Genomics, mHealth) , small businesses, Nifty-Fifty Nominee nationwide, Speaker, Volunteer at USA Science Festival.
Deadline for Abstracts: 2013-04-25

NetZealous LLC,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
E-mail: globalcompliancepanel@gmail.com
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