2nd Disclosure and Transparency for Clinical Data Summit - Philadelphia, PA

2nd Disclosure and Transparency for Clinical Data Summit
August 13 - 14, 2018
Philadelphia, PA
Philadelphia, PA

Balance Your Commercial Values and Ethical Responsibilities Through the Vigilant Execution of National and Global Data Transparency

Agenda – 2nd Disclosure and Transparency for Clinical Data Summit



Day One

 Monday, August 13

9:00AM – 9:15AM

Chairperson’s Opening Remarks


Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB

9:15AM – 10:00AM

Case Study: Objectives, Endpoints, and Outcome Measures: Developing the Protocol to Achieve Consistency Between Documents and Registrations


Nate Root, MSA, Associate Director, Clinical Disclosure and Transparency, IONIS PHARMACEUTICALS, INC.

10:00AM – 10:45AM

Tackling the Disclosure and Transparency Process Completely In-House


Lauryn Uribe, B.S., MBA, Associate Manager, Disclosure and Transparency, GILEAD

10:45AM – 11:15AM

Networking Break


11:15AM – 12:00PM

Fixing the Compliance Challenge on EU CTR


Thomas Wicks, Chief Strategy Officer, TRIALSCOPE

12:00PM – 1:00PM

Luncheon


1:00PM – 2:00PM

Panel Discussion — Infrastructural Issues With Data Transparency


Panelist
Kristen Bolt, Research Data Management Consultant, Boston Children’s Hospital
Nate Root, MSA, Associate Director, Clinical Disclosure and Transparency, IONIS PHARMACEUTICALS, INC.
Laura Troast, Director, Clinical Data Disclosure & Transparency, MERCK
Annadoir Staveleyl, Associate Director of Clinical Trial Disclosure and Transparency, Ethics and Compliance, Otsuka America Pharmaceutical, Inc.

2:45PM – 3:30PM

Sharing Aggregate and Individual Results of Clinical Trials With Study Participants


Carmen E. Aldinger, Ph.D., MPH, PMP, Administrative and Training Manager, MULTI-REGIONAL CLINICAL TRIALS CENTER OF BRIGHAM AND WOMEN’S HOSPITAL AND HARVARD

3:30PM – 4:00PM

Networking Break


4:45PM – 5:30PM

Planning Clinical Trials With the Disclosure Endpoint in Mind


Sulochana Gawande, Head of Submission Writing and Director of Publications, EISAI


Day Two

 Tuesday, August 14

8:00AM – 8:45AM

Continental Breakfast


8:45AM – 9:00AM

Chairperson’s Recap of Day One


Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB

9:00AM – 9:45AM

Case Study: End-to-End Disclosure Planning — Joining the Dots and Connecting the World


Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB

9:45AM – 10:30AM

Overcoming Hurdles of Non-Compliant Clinical Trial Transparency


Oladayo Oyelola, Ph.D., Director, Clinical Trial Information Disclosure, DAIICHI SANKYO

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

Patient Perspective on Lay Summaries


Behtash Bahador, Senior Manager, Quality and Compliance, CISCRP

11:45AM – 12:30PM

Combination of Data From Different Clinical Trials


Bryan Stefanski, Compliance Director, SIEMENS HEALTHCARE

12:30PM – 1:30PM

Luncheon


1:30PM – 2:15PM

Panel Discussion: Clarification of Data Protection Vs. Data Openness


Panelist
Kristen Bolt, Research Data Management Consultant, Boston Children’s Hospital
Laura Troast, Director, Clinical Data Disclosure & Transparency, MERCK

2:15PM – 3:30PM

Explore the Various Regulations Driving Publication of Clinical Study Documents in North America and the EU


Julie Holtzople, Clinical Trial Transparency Operations Director, AstraZeneca


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