Is your nonclinical data compliant with CDISC SEND? The FDA mandate for using the CDISC Standard Exchange of Nonclinical Data (SEND) format for electronic submission goes into effect for studies started on or after 2016 年 12 月 18 日. The mandate is required for data contained in NDA, ANDA, and BLA filings. Lack of compliance in SEND submissions may result in a refusal to file (RTF) and delays.
In this express webinar led by Chris Lovejoy, learn how NCA data needs to be prepared, transformed, and formatted to be SEND-ready and how Phoenix tools can save time, reduce errors, and increase compliance. Chris, manager of deployment services for Phoenix, is a member of the Royal Pharmaceutical Society and has over two decades of experience working with leading pharmaceutical companies.
About Our Speaker
Chris Lovejoy has been with Certara for over 16 years. Originally qualifying as a Pharmacist, his experience in the Pharmaceutical Industry includes PK/PD analysis, Drug Safety and Clinical Data Management. Based in the UK, Chris has been in involved in all the major European deployments of Phoenix solutions, acting as a technical and project management lead.
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Certara is a CDISC Registered Solutions Provider |
Is your nonclinical data compliant with CDISC SEND? The FDA mandate for using the CDISC Standard Exchange of Nonclinical Data (SEND) format for electronic submission goes into effect for studies started on or after 2016 年 12 月 18 日. The mandate is required for data contained in NDA, ANDA, and BLA filings. Lack of compliance in SEND submissions may result in a refusal to file (RTF) and delays.
In this express webinar led by Chris Lovejoy, learn how NCA data needs to be prepared, transformed, and formatted to be SEND-ready and how Phoenix tools can save time, reduce errors, and increase compliance. Chris, manager of deployment services for Phoenix, is a member of the Royal Pharmaceutical Society and has over two decades of experience working with leading pharmaceutical companies.
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Certara is a CDISC Registered Solutions Provider |
