Program Overview

___ Presentation
___ Panel Discussion
___ Roundtable Session
___ Plenary
07:30 AM – 08:00 PM Registration
08:00 AM – 12:00 PM Workshop 1
A Data Manager’s Guide to Risk Based Monitoring 2017
Debra Jendrasek
12:00 PM – 01:00 PM Lunch
01:00 PM – 05:00 PM Workshop 2
Preparing Data for FDA Submission
Dave Izard
05:00 PM – 06:00 PM SCDM Fair
06:00 PM – 08:00 PM Opening Reception

Subject to change

07:30 AM – 08:30 AM Registration & Breakfast
08:00 AM – 08:45 AM SCDM Business Meeting
08:45 AM – 10:00 AM Plenary Keynote
Kassa Ayalew
10:00 AM – 10:45 AM Break / Exhibits / Product Showcases
10:45 AM – 12:15 PM Session 1
Answering the Age Old Question, “Are We There Yet?”
Karen McPoyle
Session 2
Clean Data Faster: Leveraging EDC/CTMS in Global Studies
Karina Loyo
Session 3
SDV – What Is It Good For? Absolutely Nothing!
Jonathan Andrus
12:15 PM – 01:30 PM Lunch / Exhibits
01:30 PM – 03:00 PM Session 4
SDTM and CDASH: Why You Need BOTH!
Kit Howard
Session 5
Dramatic Change in China Clinical Data Management
Carrie Zhang
Session 6
ePRO: Going from Good to Great
Ben Baumann
03:00 PM – 03:45 PM Break / Exhibits / Poster Presentations / Product Showcases
03:45 PM – 05:30 PM Regulatory Panel
Moderated by Jonathan Andrus

Subject to change

07:30 AM – 08:30 AM Registration & Breakfast
07:30 AM – 08:30 AM Good Clinical Data Management Practices (GCDMP©) Revision: Status & New Chapter Highlights
08:30 AM – 10:00 AM Session 7
Emerging Trends in Clinical Data Capture and Clinical Research Technologies
Arshad Mohammed
Session 8
Fail-Safe Central Data Monitoring in RBM – How Do We Achieve It?
Abby Abraham
Session 9
IND Reports Preparation and Submission
Tanya Sun
10:00 AM – 10:45 AM Break / Exhibits / Poster Presentations / Product Showcases
10:45 AM – 12:15 PM Session 10
Improving Efficiency and Effectiveness in Data Management of Oncology Studies
Joby John
Session 11
Optimal Use of Today’s Data Management Tools When Monitoring a Clinical Site
Steve Shevel
Session 12
US and Europe Data Management after the Offshoring Efforts
Susan Howard
12:15 PM – 01:30 PM Lunch / Exhibits
01:30 PM – 03:00 PM Plenary Lecture
Technology Innovation Award – Finalists’ Presentations
03:00 PM – 03:30 PM Break / Exhibits / Prize Draw
03:30 PM – 05:00 PM Session 13
Medical Data Review
Krista Mullen
Session 14
eSource and the World of Opportunities
Susan Bornstein
Session 15
CDASH V2.0 – What’s New and How Does It Impact Me?
Dawn Kaminski
05:00 PM – 06:00 PM Becoming a Certified Clinical Data Manager (CCDM®)
Meredith Zozus
07:00 PM – 09:30 PM SCDM Networking Reception

Subject to change

07:30 AM – 08:30 AM Registration & Breakfast
08:30 AM – 10:00 AM Leadership Forum Session 16
Can You See It? Handling Imaging Data and New Imaging Criterias
Candace Shelton
Session 17
Unstructured and Structured Big Data Convergence for Bridging Clinical, Regulatory, and Commercialization
David Kiger
Session 18
Ensure Drug Adherence Monitoring and Improvement Using Electronic Devices
Michael Duvenhage
10:00 AM – 10:30 AM Break
10:30 AM – 12:00 PM Session 19
Professional Development and Graduate Degree Programs for CDM
Reza Rostami
Session 20
Artificial Intelligence and Clinical Development
Brooks Fowler
Session 21
Study Medication Compliance Data Collection Challenges
Megan Olberding
12:00 PM – 03:00 PM

Subject to change