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

This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

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