Are You Ready For The FDA's Mandate Requiring Electronic Submission Conformance to SEND and SDTM?

Duration: 60 Minutes
In this course, we will examine the 'why' behind the mandate and how it can change the way therapies are being developed, leading to faster market delivery of better drugs. We will explore FDA's vision of having electronic access to all submission data in ways that are not currently feasible. The electronic standards for exchange of nonclinical data (SEND) and clinical data (SDTM), developed by CDISC, will be discussed, focusing on SEND.
Electronic Submission Conformance to SEND and SDTM
Instructor: Laura Kaufman
Product ID: 501623
Objectives of the Presentation
Join us for this interactive 60-minute session to understand:
  • The timeline for implementation of mandate
  • How FDA is preparing for the standard
  • What pharma, biotech companies, and CROs must do to prepare for the standard
  • Regulatory guidelines and requirements – what else do you need to know?
  • The implementation experience: Going from 'planning' to 'doing'
  • The ancillary benefits to your organization
Why Should you Attend
Starting in December 2016, FDA's mandate requiring that pharma and biotech regulatory submissions conform to an electronic standard will go into effect, representing a sea change in how data is shared with research organizations, sponsors, and regulators. Nonconformance to the mandate can result in issuance of a “Refusal to File” by FDA, resulting in costly market delays. The accepted standards are offered by the Clinical Data Interchange Standards Consortium (CDISC). The Study Data Tabulation Model (SDTM) was developed for clinical data, and Standard for Exchange of Nonclinical Data (SEND) is the nonclinical implementation of SDTM. Even though you may have familiarity with these standards, many responsible for filing submissions still struggle with their implementation.

Who will Benefit
This course will be of benefit to anyone involved in compiling, documenting, or submitting clinical or nonclinical data to CROs, sponsors, or FDA working in an investigative, toxicology, pathology, or regulatory environment. Additionally, anyone looking for a high-level overview of how computerized data review and data mining are being implemented by FDA and pharma will find this course extremely valuable.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
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  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Laura Kaufman is a board-certified toxicologist (DABT) with extensive nonclinical pharmaceutical, biotech, and biodefense drug development experience. She earned her PhD in anatomy (neuroscience) from the University of Pennsylvania and completed a post-doctoral fellowship at The Rockefeller University, where her research centered on estrogenic modulation of muscarinic receptors in rat hypothalamus. She served as department head of nonclinical safety, exploratory toxicology, and cardiovascular safety pharmacology in large pharma (Wyeth) and in smaller biotech companies (Enzon, Elusys). Her experience spans large and small molecule development across most therapeutic areas, and she has played pivotal roles in designing novel ways to screen compounds for safety, resulting in several marketed products. Dr Kaufman's current interests center on standardized electronic formats for nonclinical data (SEND or Standard for Exchange of Nonclinical Data) and how they can be leveraged to facilitate drug development. She is an active member of PhUSE and CDISC and co-chair of several FDA/PhUSE working groups, including the Nonclinical Study Data Reviewer's Guide Working Group.


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