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Validity : 14th Apr'24 to 24th Apr'24
New and Expected Guidances on Data Standards and Electronic Submissions for Drugs and Medical Products
• 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
Overview of the webinar
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.
Who should attend?
• 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
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.
Faculty - Mz.Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.