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

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Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Heath,FDA

Deadline: April 25, 2013 | Date: April 25, 2013

Venue/Country: California, U.S.A

Updated: 2013-04-08 17:41:34 (GMT+9)

Call For Papers - CFP

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

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.

Price: $225.00

GlobalCompliancePanel

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Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

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