Expert Insights Webinars
How to Submit Non-Clinical Data to CBER Using SEND :
Understanding New FDA Requirements
March 7, 2023 9:00-10:00 AM EST
What You Will Learn
The FDA’s CBER will begin requiring electronic submissions of nonclinical data to be submitted using the 3.1 and 3.1.1 versions of CDISC SENDIG on March 15th, 2023. With these requirements taking effect soon, Sponsors need to understand how to meet the new rules and regulations provided by SEND, as failing to meet them could result in FDA refusal.
In this webinar, a cross-functional team of statistical programmers and regulatory experts will share actionable insights to help study teams prepare for the new requirements.
Attendees will learn how to:
- Understand nonclinical study data submissions to CDER and CBER
- Differentiate biologics from drug submission in non-clinical studies
- Prepare for this change to ensure a successful submission.
- Solve the challenges of a SEND package
- Ensure compliance with both SEND 3.1 and 3.1.1 for submission of nonclinical data to CDER and CBERHo
- Separate SEND IG DART 1.1 from SEND IG
- Manage legacy studies and studies that already meet requirements
- Differentiate between submission packages
- Use the FDA’s data standard catalog, technical conformance guide and controlled terminology
Who Will Benefit from Attending?
- Regulatory Affairs and Submissions Professionals
- Pharmaceutical Data and Programming Professionals
- Nonclinical/Preclinical Development Professionals
Satyapal Ingle is a Senior Manager of Statistical Programming with over 15 years of experience creating datasets and statistical output in the epidemiology, health care, pharmaceutical, and clinical industries. He has CDISC expertise in creating SDTM and ADaM standard datasets and has worked on IND and NDA submissions. Ingle holds a Master of Science in Biological Sciences and a Bachelor of Science in Pharmacy.
Venu Kumar Kasula is a Senior Statistical Programmer with over 10 years of experience in creating mapping specification for data transformation in compliance with CDISC-SDTM. He has additional experience in ADaM, SEND, SQL, and SAS procedures and functions. Kasula holds an MTech in Biotechnology from Jawaharlal Nehru Technological University, Hyderabad
Jami Gentry is a Technical Manager of Regulatory Operations with over 15 years of experience in the industry, including across many regulatory software and applications. Her expertise includes publishing regulatory documents and submissions according to the eCTD format. She holds an ISIToolbox Master Certification and a GCP Accreditation.
Pinnamaneni Hima Bindu is a Senior Statistical Programmer with over four years of experience in programming, including expertise in trial data sets, CRF annotation, SAS, SDTM, and ADaM, among others. She holds a bachelor's degree in Pharmacy from Osmania University and has a post-graduate diploma in Clinical Research Management.