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Data Anonymisation | Policy 0070 | U.S. Final Rule | GDPR | Lay Summary Preparation | Publication Strategy

June 20-21, 2018
  • Amsterdam, The Netherlands

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 and medical writing teams. Gather together to compare processes and exchange best practices in preparing and executing Policy 0070 submissions, ensuring compliance with GDPR, understanding data anonymisation standards 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 and strategies for managing publications strategy to develop the most widely accepted and efficient best practices.

PROGRAMME CONTENT HIGHLIGHTS INCLUDE:

  • Navigate EMA’s Further Guidance on Policy 0070 and
    Portal Preparations
  • CASE STUDY — Lessons Learned from Preparing and
    Publishing Two Dossiers for Policy 0070 Submission
  • Collaborate to Achieve Industry Harmonisation for
    Clinical Data Publication Posting
  • Understand the Impact of the EU General Data Protection
    Regulation (GDPR) on the Transparency of Clinical Trial Data
    andReports Publications
  • Piloting Lay Summaries —
    Development and Implementation of Best Practices and Processes
  • Publications Debate — Should Scientific Publications Be Used as
    Way to Fulfill Transparency Obligations?
  • Compare and Contrast Qualitative and Quantitative Data
    Anonymisation Methods

PLUS! Choose Between Two
Extended In-Conference Workshops:

A. Data Anonymisation Strategy Masterclass

B. From the Medical Writer to the Publication —
Gain Essential Tools for Writing a Peer-Reviewed Manuscript

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 | U.S. Final Rule | GDPR | Lay Summary Preparation | Publication Strategy

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 and medical writing teams. Gather together to compare processes and exchange best practices in preparing and executing Policy 0070 submissions, ensuring compliance with GDPR, understanding data anonymisation standards 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 and strategies for managing publications strategy to develop the most widely accepted and efficient best practices.

PROGRAMME CONTENT HIGHLIGHTS INCLUDE:

  • Navigate EMA’s Further Guidance on Policy 0070 and
    Portal Preparations
  • CASE STUDY — Lessons Learned from Preparing and
    Publishing Two Dossiers for Policy 0070 Submission
  • Collaborate to Achieve Industry Harmonisation for
    Clinical Data Publication Posting
  • Understand the Impact of the EU General Data Protection
    Regulation (GDPR) on the Transparency of Clinical Trial Data
    andReports Publications
  • Piloting Lay Summaries —
    Development and Implementation of Best Practices and Processes
  • Publications Debate — Should Scientific Publications Be Used as
    Way to Fulfill Transparency Obligations?
  • Compare and Contrast Qualitative and Quantitative Data
    Anonymisation Methods

PLUS! Choose Between Two
Extended In-Conference Workshops:

A. Data Anonymisation Strategy Masterclass

B. From the Medical Writer to the Publication —
Gain Essential Tools for Writing a Peer-Reviewed Manuscript

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