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, September 29th, 2016, 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.
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
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2. 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
o Discussion of overhead investment (e.g., hardware and software) by your company
o eCTD publishing and submission capabilities to meet PDUFA V eCTD requirements
o 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
o Efficient maintenance and lifecycle management of regulatory dossiers
o Complete solutions for outsourced publishing (full and partial dossiers)
o Publishing deliverables prepared in specific data systems using specific tools and
processes
o Complete solutions for paper trial master file (TMF) document indexing, scanning and
archiving
o Complete solutions for preparation and submission of electronic drug listings,
establishment registrations, labeler code registrations, lot distribution reports and GDFSI
files
o Structured product labeling
o Access to eCTD experts for submission planning, placement of content within the eCTD
structure and the development of detailed submission plans/maps
o 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

3. 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 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.
For more information, contact support @complianceglobal.us