Objectives of the Presentation
Join us for this interactive 60-minute session to understand:
Why Should you Attend
- 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
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.