Live Webinar New and Expected Guidances on Data Standards and Electronic Submissions for Drugs and Medical Products

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

The agencies (FDA, EMEA) encourage electronic submissions and they have developed data standards and other guidelines


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

•     Quality & Product Data Standards
•     Study Data Standards Update
•     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)
•     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

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Angela Bazigos

Angela Bazigos.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. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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