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Are You Ready For The FDA's Mandate Requiring Electronic Submission Conformance to SEND and SDTM?
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
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.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Description:
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.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
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
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Areas Covered:
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.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Who can 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.
Track this Link:The FDA's Mandate Requiring Electronic Submission Conformance to SEND and SDTM
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
