Develop an understanding of FDA’s new eCTD submission requirements and how compliance will assist the manufacturer

1. Overview
FDA and Electronic Common Technical Document
Date: Thursday, January 26th, 2017, Time: 01:00 PM ET | 10:00 AM PT
Duration : 60 Minutes
Speaker: Stephen Amato, PhD, MBA, RAC
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.
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2. 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.
The eCTD specification format, although currently applicable in the US, European Union
and Japanese markets may soon become the standard for other global markets as well,
including Australia, Canada, China and Brazil. Therefore, by meeting the US
requirements for eCTD submissions, manufacturers will place themselves in an optimal
position to market their healthcare products not only in the US, but in other major
geographical markets.
Areas covered in the 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

3. • Expertise regarding FDA requirements of eCTD submissions
Learning objective
• 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
• Pharmacovigilance
• Project Management
• Anyone responsible for providing content for the CTD
Speaker profile
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.
Dr. Amato has more than 25 years of experience in product commercialization in the
pharmaceutical, biotechnology and medical device industries. He currently serves as an
Associate Professor of Graduate Global Regulatory Affairs at Northeastern University.
Prior to Cardinal Health, he founded and served as the Managing Director for tJun17 Life

4. Sciences, an organization that facilitates global commercialization and market access for
early stage medical technologies.
Prior to founding tJun17 Life Sciences, Dr. Amato was the Executive Director of
Marketing at Anika Therapeutics where he managed all aspects of the company's
product portfolio including market segmentation, targeting, positioning, pricing and
promotional strategies.
From 2000 to 2007, Dr. Amato was the Group Director of Knee Repair at Smith &
Nephew Endoscopy where he managed a $140 million orthopedic product portfolio.
Prior to this experience, he worked for Visible Genetics, where he was responsible for
developing and launching genomic molecular diagnostics products used for subtyping
Human Papilloma Virus (HPV) and other infectious disease agents. He has also worked
with Critical Therapeutics on the development and commercialization of treatments for
gram negative sepsis.
Dr. Amato received a doctorate in molecular and cellular biology and a master’s degree
in business administration from Boston College. He received a bachelor’s degree in
biochemical sciences from Harvard University
For more information, contact support @complianceglobal.us