New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

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.

This online training will cover FDA’s electronic submission gateway and will alert you regarding some of the problems that are seen with electronic data submissions. Finally, the session will discuss some of the new requirements for electronic submissions to FDA and what you can expect in the future.

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

Angela Bazigos
CEO, Touchstone Technologies Inc

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance https://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ . 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 LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

Topic Background:

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.

Follow us :