New York Professional Events List


Disclosure and Transparency for Clinical Data Summit


Date
Aug 07, 2017 - 08:00 AM - Aug 08, 10:00 PM
Organizer
exlevents
Location
The Rittenhouse Hotel210 West Rittenhouse SquarePhiladelphia, PA 19103,

Philadelphia,
PA,
US,
ZIP: 19103
Phone: +1 929 900 1853

Disclosure and Transparency for Clinical Data Summit

Disclosure and Transparency for Clinical Data Summit

Transparency of clinical trial information is evolving on a global and national scale. Pharmaceutical companies and academia are overwhelmed by new regulatory requirements, operational challenges and renewed infrastructure needs to disseminate clinical trial data compliantly. These organizations are challenged to meet the ever-changing regulatory standards made by The Final Rule and EMA Policy 0070 of current, past and future clinical trials, but are struggling to establish compliant data transparency without universal regulations, standardized processes or regulatory support.

The Disclosure and Transparency for Clinical Data Summit convenes industry professionals to examine the global and national legislative landscape of data disclosure and transparency. The expert speaking faculty will determine the required internal infrastructure, resources and best practices to disclose transparent data that balances commercial and ethical responsibilities. Case studies will outline how to harmonize and standardize the execution of clinical trial data disclosure that meets federal and global criteria. This summit will provide attendees with the tools to be proactive in the changing regulatory environment to ultimately disclose transparent data that promotes brand integrity and ensures public understanding of the trial processes and results.

Top Five Reasons to Attend

  1. Examine the regulatory landscape on a national and global scale to prepare for the coming changes and audits in order to be proactive instead of reactive
  2. Assess your internal resources to define your outsourcing needs to remain compliant and transparent
  3. Establish best practices to adhere to the living documents that define the regulations for data disclosure and transparency in the future, present and past
  4. Discuss your ethical responsibility in conjunction with your commercial values to balance commercial confidentiality and public access
  5. Outline the steps and procedures to ensure organizational discipline from executives to associates in disclosure operations

Who Should Attend

This conference is designed for representatives from pharmaceutical, biotechnology and medical device organizations with responsibilities in the following areas:

  • Clinical Trial Disclosure and Transparency
  • Clinical Trial Information Disclosure/Management
  • Clinical Operations
  • Data Management/Standards
  • Regulatory Affairs
  • Clinical Trial Registration
  • Publication Planning
  • Medical Writing
  • Information/Knowledge Management
  • Strategic Projects Management
  • Medical Communications
  • Patient Engagement
  • Biostatistics/Bioinformatics
This conference is also of interest to:
  • Data Reporting/Transparency Solution Providers
  • Medical Writing/Publication Services
  • Discrepancy Management/Data Management Service Provider
  • Legal Consultants
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Please contact the event manager Marilyn below for the following:
 
- For Tickets/Registrations,
- Discounts for registering  5 or more participants.
- If you company requires a price quotation.
 
Event Manager Contact:


marilyn.b.turner(at)nyeventslist.com or Contact:  +1 929 900 1853
 
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
 
NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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This Event Listing is Promoted by  New York Media Technologies LLC in association
with EXL Events Inc.

 
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Agenda


Day One
Monday, August 7, 2017

8:00AM – 8:45AM
Registration Opens and Continental Breakfast
8:45AM – 9:00AM
Chairperson’s Opening Remarks
Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB
9:00AM – 10:00AM
Open Patient Data Access and Sharing: Where Are We on the Journey and Is the Destination Worth the Cost of the Trip?
Frank Rockhold, Ph.D., Professor of Biostatistics and Bioinformatics, Duke Clinical Research Institute, DUKE UNIVERSITY MEDICAL CENTER
10:00AM – 10:45AM
A Holistic Approach to the Evolving Transparency Landscape
Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB
10:45AM – 11:15AM
Networking Break
11:15AM – 12:00PM
EMA Policy 0070 Lessons Learned & Best Practices Gained from 3 Case Studies
Lora Killian, Director, Transparency and Disclosure, SYNCHROGENIX
12:00PM – 12:45PM
Strategic and Practical Disclosure Considerations Regarding the EMA Policy 0070 Update
René Allard, Public Disclosure Lead, GRÜNENTHAL GMBH
12:45PM – 1:45PM
Luncheon
1:45PM – 2:30PM
Examine Data Disclosure Methods to Achieve Full Transparency and to Ensure Credibility
Debra Mayo, Vice President, Global Scientific Communications, TEVA
2:30PM – 3:15PM
Implement and Manage a Clinical Disclosure Group or Process for Your Organization
Frantz Derilus, Associate Director, Clinical Trial Transparency, SHIRE
3:15PM – 3:45PM
Networking Break
3:45PM – 4:30PM
Align Timelines, Communication Resources and Data Across Functions to Optimize Transparency and Disclosure
Oladayo Oyelola, Ph.D., Director, Clinical Trial Information Disclosure, DAIICHI SANKYO
4:30PM – 5:15PM
Standardize Manual Processes to Accomplish Data Disclosure and Clinical Trial Registry
Laura Troast, M.S., Associate Director, Clinical Data Disclosure and Transparency, MERCK
5:15PM – 6:00PM
Case Study: Johnson & Johnson’s Yale Open Data Access (YODA) Project
Karla Childers, Senior Director, Strategic Projects, JOHNSON & JOHNSON
6:00PM – 6:15PM
Chairperson’s Closing Remarks
Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB
6:15PM –
Day One Concludes
 

Day Two
Tuesday, August 8, 2017

8:00AM – 9:00AM
Continental Breakfast
9:00AM – 9:15AM
Chairperson’s Recap of Day One
Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB
9:15AM – 10:00AM
Enable Next Generation Smart Processes Through Federated Informatics Technology
Greg Koski, M.D., Ph.D., President and CEO, ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES)Associate Professor, MASSACHUSETTS GENERAL HOSPITAL, HARVARD MEDICAL SCHOOL; Senior Scientist, , MONGAN INSTITUTE FOR HEALTH POLICY
10:00AM – 10:45AM
SHRINE (Shared Health Research Information Network): Enable Patient Cohort Identification for Accrual to Clinical Trials
Bhanu Bahl, Ph.D., Director, Clinical and Translational Science Center, HARVARD MEDICAL SCHOOL
10:45AM – 11:15AM
Networking Break
11:15AM – 12:00PM
Strategies and Resources for Sharing Clinical Research Data in Academia
Kristen Bolt, Program Manager, Data Sharing and Transparency, MULTI-REGIONAL CLINICAL TRIALS CENTER OF BRIGHAM AND WOMEN’S HOSPITAL AND HARVARD
12:00PM – 1:00PM
Luncheon
1:00PM – 1:45PM
Best Practices for Balancing Your Organization’s Commercial Value and Data Sharing
Pranab Mitra, Ph.D., Principal Biostatistician, BRISTOL-MYERS SQUIBB
1:45PM – 2:30PM
The Challenges of Medical Writing in Clinical Trial Disclosure
Sulochanda Gawande, Ph.D., Director, Oncology Medical Writing and Publications, EISAI
2:30PM – 3:15PM
Implement Disclosure Infrastructure to Facilitate Rapid Changes to Preexisting Data
Nathaniel Root, Global Clinical Trial Registration and Results Disclosure Lead, TAKEDA
3:15PM – 4:00PM
Lay Language Summaries as Tools for Patient Engagement: Driving Patient Engagement Through Sharing Overall Trial Results
Julia Farides-Mitchell, M.A., Senior Project Manager, CENTER FOR INFORMATION & STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)
4:00PM – 4:15PM
Chairperson’s Closing Remarks
Liz Roberts, Senior Director, Global Lead Transparency and Data Sharing, UCB
4:15PM –
Conference Concludes
 
 


Speaker Details


Featured Speakers


Event Categories
BUSINESS & MANAGEMENT CONFERENCES
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HEALTH AND MEDICINE CONFERENCES
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Healthcare
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Technology
Keywords: fun, access , Clinical , communication , conference , design , environment, Fun , industry , iO




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