Program Overview

___ Presentation
___ Panel Discussion
___ Roundtable Session
___ Plenary
07:30 AM – 08:00 PM Registration

The Ritz Carlton Foyer

08:00 AM – 12:00 PM Workshop 1 (Fully booked!)
A Data Manager’s Guide to Risk Based Monitoring 2017
Debra Jendrasek
Siena I & II
12:00 PM – 01:00 PM Lunch
01:00 PM – 05:00 PM Workshop 2
Preparing Data for FDA Submission
Dave Izard
Siena I & II
05:00 PM – 06:00 PM SCDM Fair
Palazzo Foyer
06:00 PM – 08:00 PM Opening Reception
Palazzo Ballroom (Exhibit Hall)

Subject to change

07:30 AM – 08:30 AM Registration & Breakfast

The Ritz Carlton Foyer

08:00 AM – 08:45 AM SCDM Business Meeting

The Ritz Carlton Ballroom III & IV

08:45 AM – 10:00 AM Keynote Presentation
FDA Perspective on International Clinical Trials

Kassa Ayalew
The Ritz Carlton Ballroom III & IV
10:00 AM – 10:45 AM Break – Exhibits – Product Showcases

Palazzo Ballroom 

10:45 AM – 12:15 PM Session 1
Answering the Age Old Question, “Are We There Yet?”
Karen McPoyle
The Ritz Carlton Ballroom I & II
Session 2
Clean Data Faster: Leveraging EDC/CTMS in Global Studies – The Bar is Raising Swiftly – 
Karina Loyo
The Ritz Carlton Ballroom III & IV
Session 3
SDV – What Is It Good For? Absolutely Nothing!
Jonathan Andrus
The Ritz Carlton Ballroom V & VI
12:15 PM – 01:30 PM Lunch – Exhibits

Palazzo Ballroom

01:30 PM – 03:00 PM Session 4
SDTM and CDASH: Why You Need BOTH!
Kit Howard
The Ritz Carlton Ballroom III & IV
Session 5
Dramatic Change in China Clinical Data Management
Carrie Zhang
The Ritz Carlton Ballroom I & II
Session 6
ePRO: Going from Good to Great
Ben Baumann
The Ritz Carlton Ballroom V & VI
03:00 PM – 03:45 PM Break – Exhibits –  Product Showcases

Palazzo Ballroom
Poster Presentations
Palazzo Foyer

03:45 PM – 05:30 PM Regulatory Panel
Moderated by Jonathan Andrus
The Ritz Carlton Ballroom III & IV

Subject to change

07:30 AM – 08:30 AM Registration & Breakfast

The Ritz Carlton Foyer

07:30 AM – 08:30 AM Good Clinical Data Management Practices (GCDMP©) Revision: Status & New Chapter Highlights
Meredith Nahm-Zozus & Marysasser Holloway
Siena I & II
08:30 AM – 10:00 AM Session 7
Emerging Trends in Clinical Data Capture and Clinical Research Technologies
Arshad Mohammed
The Ritz Carlton Ballroom III & IV
Session 8
Fail-Safe Central Data Monitoring in RBM – How Do We Achieve It?
Abby Abraham
The Ritz Carlton Ballroom I & II
Session 9
IND Reports Preparation and Submission
Tanya Sun
The Ritz Carlton Ballroom V & VI
10:00 AM – 10:45 AM Break –  Exhibits –  Product Showcases

Palazzo Ballroom
Poster Presentations
Palazzo Foyer

10:45 AM – 12:15 PM Session 10
Improving Efficiency and Effectiveness in Data Management of Oncology Studies
Joby John
The Ritz Carlton Ballroom I & II
Session 11
Optimal Use of Today’s Data Management Tools When Monitoring a Clinical Site
Steve Shevel
The Ritz Carlton Ballroom III & IV
Session 12
US and Europe Data Management after the Offshoring Efforts
Susan Howard
The Ritz Carlton Ballroom V & VI
12:15 PM – 01:30 PM A Dialog On Integrated eSource Into Clinical Research 
Anita Walden & Linda King
Siena I & II
12:15 PM – 01:30 PM Lunch – Exhibits

 Palazzo Ballroom

01:30 PM – 03:00 PM Technology Innovation Award – Finalists’ Presentations

Charlene Dark
The Ritz Carlton Ballroom III & IV

03:00 PM – 03:30 PM Break / Exhibits / Prize Draw
Palazzo Ballroom
03:30 PM – 05:00 PM Session 13
Medical Data Review
Krista Mullen
The Ritz Carlton Ballroom I & II
Session 14
eSource and the World of Opportunities
Susan Bornstein
The Ritz Carlton Ballroom III & IV
Session 15
CDASH V2.0 – What’s New and How Does It Impact Me?
Dawn Kaminski
The Ritz Carlton Ballroom V & VI
05:00 PM – 06:00 PM Becoming a Certified Clinical Data Manager (CCDM®)
Meredith Zozus
Siena I & II
07:00 PM – 09:30 PM SCDM Networking Reception
Grande Lakes Da Vinci Terrace & Lawn (outdoor space)

Subject to change

07:30 AM – 08:30 AM Registration & Breakfast

The Ritz Carlton Foyer

08:30 AM – 10:00 AM Leadership Forum

Genoa II

Session 16
Can You See It? Handling Imaging Data and New Imaging Criterias
Candace Shelton
The Ritz Carlton Ballroom I & II
Session 17
Unstructured and Structured Big Data Convergence for Bridging Clinical, Regulatory, and Commercialization
David Kiger
The Ritz Carlton Ballroom III & IV
Session 18
Management of Electronic Drug Adherence Data, Monitoring Devices, as Well as Real Time Data Monitoring
Michael Duvenhage
The Ritz Carlton Ballroom V & VI
10:00 AM – 10:30 AM Break

The Ritz Carlton Foyer

10:30 AM – 12:00 PM Session 19
Professional Development and Graduate Degree Programs for CDM
Reza Rostami
The Ritz Carlton Ballroom I & II
Session 20
Artificial Intelligence and Clinical Development
Scott Weidley
The Ritz Carlton Ballroom III & IV
Session 21
Study Medication Compliance Data Collection Challenges
Megan Olberding
The Ritz Carlton Ballroom V & VI
12:00 PM – 03:00 PM

Subject to change