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Disclosure and Transparency for Clinical Data Summit 2018

Mon, August 13 - Tue, August 14, 2018 Philadelphia, Pennsylvania
Philadelphia, Pennsylvania United States

About Disclosure and Transparency for Clinical Data Summit 2018

DISCLOSURE AND TRANSPARENCY FOR CLINICAL DATA SUMMIT, PHILADELPHIA, AUGUST 13-14, 2018

To combat the burden of new regulatory requirements, operational challenges and renewed infrastructure needs, the life science industry must take a holistic and collaborative approach to achieving data disclosure compliance. Through data disclosure and transparency, life science organizations decrease the chances of clinical trial duplication, ensure public understanding and access, and ultimately promote brand integrity.

At the 2nd Disclosure and Transparency for Clinical Data Summit, the star-studded speaking faculty will define standardization processes for disclosure and registry, provide best practices to balance commercial confidentiality and public access, and examine proven tactics that preserve data utility while ensuring adequate anonymization. This summit will provide you with the tools to ultimately maximize the benefits of clinical data from the inherent risks of clinical trials, all while complying with national and global compliance regulations.

Who Should Attend

This conference is designed for professionals from pharmaceutical companies 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              

Top Five Reasons to Attend

  • Discuss the description of the risk-based approach to balance patient privacy with data utility
  • Propose best practices for clinical development planning that include effective collaboration leading to practical disclosure solutions
  • Discuss emerging best practices for tracking and managing global disclosure
  • Limit internal data discrepancies by merging resources across data integrity, validation and transparency departments
  • Encourage sprightly adaptation, regardless of company size, to new regulations through novel infrastructure

 

About Disclosure and Transparency for Clinical Data Summit 2017

Disclosure and Transparency for Clinical Data Summit, August 07-08, 2017

What is this event?

The Disclosure and Transparency for Clinical Data Summit will call industry professionals together to examine the global and national legislative landscape of data disclosure and transparency.

The expert speaking faculty will establish 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.

Summit will provide tools to attendees, how to be a 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.

Where is this event located?
This event will take place at Rittenhouse Hotel, 210 W Rittenhouse Square, Philadelphia, Pennsylvania, USA.

Who should attend this event?

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

What are some highlights of this event?

Event Highlights:

  • Open Patient Data Access and Sharing: Where are We on the Journey and Is the Destination Worth the Cost of the Trip?
  • Best Practices for Anonymizing Structured Clinical Trial Data for Disclosure
  • EMA Policy 0070 Lessons Learned & Best Practices Gained from 3 Case Studies
  • Strategic and Practical Disclosure Considerations Regarding the EMA Policy 0070 Update
  • A Holistic Approach to the Evolving Transparency Landscape
  • The Global Transparency Challenge
  • Align Timelines, Communication Resources and Data Across Functions to Optimize Transparency and Disclosure
  • Case Study: Johnson & Johnson’s Yale Open Data Access (YODA) Project
  • Implement and Manage a Clinical Disclosure Group or Process for Your Organization
  • Enable Next Generation Smart Processes Through Federated Informatics Technology
  • SHRINE (Shared Health Research Information Network): Enable Patient Cohort Identification for Accrual to Clinical Trials
  • The Challenges of Medical Writing in Clinical Trial Disclosure
  • Lay Language Summaries as Tools for Patient Engagement: Driving Patient Engagement Through Sharing Overall Trial Results
  • Examine Data Disclosure Methods to Achieve Full Transparency and to Ensure Credibility

Speakers:

  • Liz Roberts
  • Frank Rockhold
  • René Allard
  • Greg Koski, M.D., Ph.D.
  • Oladayo Oyelola, Ph.D.
  • Laura Troast, M.S.

Why should I attend this event?

By attending this event you will:

  • 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.
  • Assess your internal resources to define your outsourcing needs to remain compliant and transparent.
  • Establish best practices to adhere to the living documents that define the regulations for data disclosure and transparency in the future, present and past.
  • Discuss your ethical responsibility in conjunction with your commercial values to balance commercial confidentiality and public access.
  • Outline the steps and procedures to ensure organizational discipline from executives to associates in disclosure operations.

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