Disclosure and Transparency for Clinical Data Summit – Disclosure and Transparency for Clinical Data Summit

Featured Speakers

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