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DATA ANONYMISATION • POLICY 0070 UPDATES • BREXIT • GDPR • LAY SUMMARY PREPARATION • CSR WRITING AND REDACTION

June 12-13, 2018
  • Lisbon, Portugal

In its 7th year, CBI’s Publication and Clinical Trial Transparency creates a bridge between the key stakeholders from clinical trial transparency, disclosure, publications, data anonymisation, medical writing and medical affairs teams in preparing and executing policy 0070 submissions, ensuring compliance with GDPR, understanding data anonymisation standards, evaluating the effects of Brexit and the move of the EMA on data transparency, and building compliant processes in alignment with other global regulations including EU Clinical Trials Regulation and U.S. FDAAA Final Rule. Join us at this critical time of change in the global clinical trials landscape to benchmark with peers on the ever-evolving transparency requirements to develop the most widely accepted and efficient best practices.

Featured Highlights Include:

  • Case study – Using a Quantitative Approach to Policy 0070 Submissions
  • Prepare for Phase II of Policy 0070 through Leveraging Data Anonymisation Risk Analysis
  • Bridge the Gaps in Cross-Functional Team Management for More Effective Communication Among Teams
  • Share Lessons Learned from Lay Summary Pilot Programs
  • Navigate Lay Language Journal Submissions with Patient Review
  • Establish Redaction Standards for CSRs in the New Age of Submissions
  • Analyze Trickle-Down Effects of the European GDPR on Data Transparency Processes
  • Benchmark with Peers on Data Anonymisation Best Practices
  • Prepare Publications Strategy in Coordination with Transparency Teams

Previous Attendee Acclaim:

Outstanding event in the field, with great professionals, that fulfilled my expectations.

Clinical Information Lead, Almirall

Good chance to meet peers in the industry, to know more about not only legal article but also possible
solutions for daily work

Senior Clinical Trial Associate, Bayer

Always a good venue to hear candid views on forthcoming regulations and share ways to implement them

Director, Scott Pharma Solutions

Informative congress and necessary with an ever-evolving regulatory landscape that impacts publications
and medical communication

Medical Writer, Envision Pharma Group

Very comprehensive and followed a good flow

Senior Medical Writer, Kinapse

Great Networking event, very open people

Medical Writer, Boehringer Ingelheim Pharma GmbH

7th Annual Publication and Clinical Trial Transparency

DATA ANONYMISATION • POLICY 0070 UPDATES • BREXIT • GDPR • LAY SUMMARY PREPARATION • CSR WRITING AND REDACTION

In its 7th year, CBI’s Publication and Clinical Trial Transparency creates a bridge between the key stakeholders from clinical trial transparency, disclosure, publications, data anonymisation, medical writing and medical affairs teams in preparing and executing policy 0070 submissions, ensuring compliance with GDPR, understanding data anonymisation standards, evaluating the effects of Brexit and the move of the EMA on data transparency, and building compliant processes in alignment with other global regulations including EU Clinical Trials Regulation and U.S. FDAAA Final Rule. Join us at this critical time of change in the global clinical trials landscape to benchmark with peers on the ever-evolving transparency requirements to develop the most widely accepted and efficient best practices.

Featured Highlights Include:

  • Case study – Using a Quantitative Approach to Policy 0070 Submissions
  • Prepare for Phase II of Policy 0070 through Leveraging Data Anonymisation Risk Analysis
  • Bridge the Gaps in Cross-Functional Team Management for More Effective Communication Among Teams
  • Share Lessons Learned from Lay Summary Pilot Programs
  • Navigate Lay Language Journal Submissions with Patient Review
  • Establish Redaction Standards for CSRs in the New Age of Submissions
  • Analyze Trickle-Down Effects of the European GDPR on Data Transparency Processes
  • Benchmark with Peers on Data Anonymisation Best Practices
  • Prepare Publications Strategy in Coordination with Transparency Teams

Previous Attendee Acclaim:

Outstanding event in the field, with great professionals, that fulfilled my expectations.

Clinical Information Lead, Almirall

Good chance to meet peers in the industry, to know more about not only legal article but also possible
solutions for daily work

Senior Clinical Trial Associate, Bayer

Always a good venue to hear candid views on forthcoming regulations and share ways to implement them

Director, Scott Pharma Solutions

Informative congress and necessary with an ever-evolving regulatory landscape that impacts publications
and medical communication

Medical Writer, Envision Pharma Group

Very comprehensive and followed a good flow

Senior Medical Writer, Kinapse

Great Networking event, very open people

Medical Writer, Boehringer Ingelheim Pharma GmbH