Starting in May of 2017, NDA, ANDA, BLA and Master File documentation must be submitted to the US Food and Drug Administration (FDA) in the new standard electronic common technical documentation (CTD) format.
In addition, beginning in May 2018, all commercial IND submissions to FDA must be filed in eCTD publishing format as well. The CTD format was developed to assemble all the Quality, Safety and Efficacy information in a common format. This format has revolutionized the regulatory review processes in the US, Europe and Japan. It has also led to harmonized electronic submissions that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different International Conference on Harmonization (ICH) regulatory authorities.
The CTD is organized into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the FDA.
Why Should You Attend:
Today’s competitive global health care market demands that product manufacturers commercialize their products with expediency. There are many global markets for which there is an unmet medical need for safe and effective therapies, including orphan drug markets, pediatric care, oncology and infectious diseases. Challenges included in the backdrop of this scenario include, regulatory as well as reimbursement and pricing challenges. In addition, regulatory requirements to obtain marketing approval can differ substantially between global markets, and regulatory professionals must often meet and complete a wide variety of regulatory submissions, depending on the geographic market of interest.
One of the complexities associated with compilation of clinical and regulatory data into the eCTD guidelines format is transitioning from the standard FDA Form 1571 and FDA Form 356h format to the CTD modular format. Although from a theoretical perspective, the content of a CTD submission should not differ substantially from the traditional paper based regulatory formats, regulatory professionals may often be confused by the CTD modular format. In addition, when each module must be completed in an electronic format that is compatible with FDA software compliance, issues may arise with an inability for FDA to recognize the software utilized by a particular manufacturer.
Areas Covered in this Webinar:
• The format and structure of complete eCTD submission solutions
• Discussion of overhead investment (e.g., hardware and software) by your company
• eCTD publishing and submission capabilities to meet PDUFA V eCTD requirements
• Complete solutions for publishing of clinical study reports (CSRs) in eCTD-compliant and/or ICH E3 format to ensure reports are submission ready for investigational and marketing applications
• Efficient maintenance and lifecycle management of regulatory dossiers
• Complete solutions for outsourced publishing (full and partial dossiers)
• Publishing deliverables prepared in specific data systems using specific tools and processes
• Complete solutions for paper trial master file (TMF) document indexing, scanning and archiving
• Complete solutions for preparation and submission of electronic drug listings, establishment registrations, labeler code registrations, lot distribution reports and GDFSI files
• Structured product labeling
• Access to eCTD experts for submission planning, placement of content within the eCTD structure and the development of detailed submission plans/maps
• Expertise regarding FDA requirements of eCTD submissions
• Develop an understanding of FDA’s new eCTD submission requirements
• Be able to describe the structure and format of an eCTD submission and also the differences between the electronic format and paper based FDA submissions
• Explain how compliance with FDA’s eCTD submission format will assist the manufacturer with expedient commercialization of new healthcare products
Who Will Benefit:
• Regulatory Affairs Professionals
• Clinical Operations Personnel
• Manufacturing Employees
• Quality Assurance
• Project Management
• Anyone responsible for providing content for the CTD
Stephen Amato, PhD, MBA, RAC, is Managing Director, East Coast Operations, for the Regulatory Sciences group of Cardinal Health Specialty Solutions. Dr. Amato is responsible for managerial and operational oversight of the East Coast business segment, including development of strategic business initiatives and management of Cambridge office associates. He is responsible for the growth of East Coast business and interacts directly with clients and global regulatory health authorities, including participating in and facilitating discussions.
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