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Workshop: SEND Submissions Demystified

Course Description

This workshop provides opportunities for participants engaged in, or contemplating SEND implementation to exchange collective experience and to gain a cohesive understanding of FDA SEND Submission expectations. The focus of the workshop will primarily be on SEND business processes with some high-level discussion of the technical aspects of SEND.

As the go-live date for SEND approaches, companies are at various stages of SEND implementation. Based on formal and informal exchanges, understanding of what constitutes successful SEND implementation continues to be a topic of intense discussion. Engaging all stakeholders with a role in SEND implementation, including the US Food and Drug Administration, provides a key opportunity for all invested parties to come to an understanding of SEND submission expectations.

Course Schedule

Tuesday, May 3

Introduction—Objectives of the Workshop, Kenjie Amemiya, Genentech

SEND Business Process from Start to Finish, Nidhi Jindal, Genentech; William Houser, Bristol-Myers Squibb; Sue DeHaven, Sanofi

Sponsor Experience with a US FDA Pilot and Submission, William Houser, Bristol-Myers Squibb

What Does the US FDA Expect in a SEND Pilot and Live Submission, John Ho, Project Management Officer, Office of Computational Science, US FDA

Future Horizons on SEND—New and Challenging Domains, Gretchen Dean, Pfizer; Lou Ann Kramer, CDISC SEND Team Leader

Topics Covered

  • Conducting SEND Pilot submissions with the US FDA
  • Validation of SEND implementation software
  • SEND Data Mapping Experience
  • Study Report QCing to SEND files
  • SEND file management for multi-site studies—external (CRO) and internal (i.e., Sponsor Testing Facility) (i.e., CRO in-life and necropsy data with in-house (Sponsor-conducted histopathology data)
  • SEND Submission Process from data collection to the US FDA
  • SEND submission package content—i.e., SEND files, SDRG (study data reviewers guide), SDSP (Study Data Standardization Plan)
  • US FDA process for accepting/rejecting SEND packages and providing feedback on error messages
  • Future Horizons—New/Challenging domains and study types. Sponsor/CRO experiences around PK/TK parameters, biomarkers, ADA and new study designs

The workshop will be divided into lectures and case study discussions. Lecturers will provide an overview of the topics, which may include their particular experiences. Case studies will be designed to provide additional experience in dealing with SEND implementation and submission processes. The audience will be divided into breakout groups of approximately eight individuals and provided case studies to review and from which to learn. Participants are encouraged to bring their laptops for case study work.

Continental breakfast and a boxed lunch are provided as part of the registration. Course handouts will be provided electronically. Participants should bring a personal laptop to view materials and to participate in the break-out sessions.

Times

Registration and Continental Breakfast: 7:00 AM–8:00 AM

Workshop: 8:00 AM–5:00 PM

Course Location

Sheraton Reston

11810 Sunrise Valley Dr

Reston, Virginia

Course Organizers

Kenjie Amemiya, Genentech; Lorrene Buckley, Eli Lilly & Company

Registration

Advance registration is required and space is limited to 80 seats.

The course is now sold out. Please contact acthq@actox.org if you would like to be placed on the waitlist.

Registration Fees:

  Register by April 28
ACT Member $50
Nonmember $75
Government $50

Refund Policy:
After 4/29/16 no fees will be refunded.

Housing

Housing Deadline:

Please use the online reservation system or call 800.561.9186 and mention that you are with the ACT SEND Room Block to receive the group rate of $159 per night. The housing deadline is April 21, 2016.

Requirements

Participants should bring a personal laptop to view workshop materials and a computer charger. We also suggest downloading all the workshop material to your laptop prior to arriving at the course. SEND Workshop materials will be provided approximately one week before the start of the course.

 


















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