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• Global Regulatory Updates • Data Sharing Expectations • Results Posting Requirements

June 27-28, 2017
  • Barcelona, Spain

With more stringent focus on posting results publicly, it is a necessity to align the registration process, results release, report writing and publication. Now in its sixth year, CBI’s Publication and Clinical Trial Transparency congress is the only life sciences forum that convenes publication planning and clinical trial registry, transparency and disclosure professionals to share strategies and benchmark plans for coordinating results postings in registries and journals, ensuring transparency and compliance with global regulations.

Why This Conference? Why Now?

The regulatory environment is heating up with new and evolving developments within this space, including the mandatory EMA data sharing policy, expanded rulemaking for FDAAA, modified EudraCT database posting timelines, new EFPIA code on transfers of value, forthcoming Clinical Trials Regulation and pending GPP3 guidelines.

Industry is responding to these recent shifts together and CBI’s Publication and Clinical Trial Transparency congress provides much-needed best practice benchmarking and knowledge-sharing on publication and data sharing initiatives.

Benefit from Expert Insights On:

  • Experiences and lessons learned from companies sharing patient-level data and posting to the EudraCT database
  • Preparations for the public disclosure of transfers of value made to healthcare professionals and organizations
  • Guidelines to prepare and deliver patient lay summaries
  • Compliance with Good Publication Practice 3 (GPP3)
  • Communicating the results of trials to investigators and patients
  • Navigating varying posting requirements on ClinicalTrials.gov, EudraCT and other local registries
  • Avoiding open access fraudulent publishing
  • Discussing initial experiences with the posting requirement from NIH Final Rule of FDAAA
  • The redaction of clinical study reports (CSRs) for patient confidentiality
  • Analyzing the legal status of EMA Policy 0070

Previous Attendee Acclaim:

An excellent, highly interactive, targeted congress that attracts experts in their fields who willingly share their expertise.

Director, Scott Pharma Solutions Ltd.

The attendees represent a wide range of organizations, from the largest life sciences companies to organizations with very small trial portfolios, which makes for very interesting discussions.

COO, TrialScope

This conference was extremely helpful for me, as an academic cooperative group representative, to exchange views with and understand the work models and expectations of the industries with which we regularly partner for conducting cancer trials.

Associate Head, Statistics Department, Head, IDMC Unit, EORTC Headquarters

Good discussion and open exchange of experiences
related to public disclosure. Thanks!

Head, Medical Writing & Public Disclosure, Grunenthal GmbH

Interesting to mix publications and clinical trial disclosure audience — this should encourage us to work more
together in the future.

Anonymous

A great opportunity to share experiences with
your peers in the industry.

Disclosures Manager, F. Hoffmann-La Roche AG

This conference is very relevant and the output received will
be beneficial to the coming months/years working
with clinical trial disclosure.


IT Systems Manager, Novo Nordisk AS

It is a great platform for sharing of knowledge and
connecting people.

Associate Medical Writer, Novo Nordisk

Excellent to combine publications and disclosure
to find common touch points.


Global Publication Manager, LEO Pharma

Nice conference with high level of experts. I learned a lot
on the current and future improvements done by the
pharmaceutical industry/EFPIA/EMA/CT.gov for
disseminating clinical trial results accurately.

Senior Biostatistician, UCB

27-28 June 2017 Hotel Barceló Sants Barcelona, Spain

Publication and Clinical Trial Transparency

• Global Regulatory Updates • Data Sharing Expectations • Results Posting Requirements

With more stringent focus on posting results publicly, it is a necessity to align the registration process, results release, report writing and publication. Now in its sixth year, CBI’s Publication and Clinical Trial Transparency congress is the only life sciences forum that convenes publication planning and clinical trial registry, transparency and disclosure professionals to share strategies and benchmark plans for coordinating results postings in registries and journals, ensuring transparency and compliance with global regulations.

Why This Conference? Why Now?

The regulatory environment is heating up with new and evolving developments within this space, including the mandatory EMA data sharing policy, expanded rulemaking for FDAAA, modified EudraCT database posting timelines, new EFPIA code on transfers of value, forthcoming Clinical Trials Regulation and pending GPP3 guidelines.

Industry is responding to these recent shifts together and CBI’s Publication and Clinical Trial Transparency congress provides much-needed best practice benchmarking and knowledge-sharing on publication and data sharing initiatives.

Benefit from Expert Insights On:

  • Experiences and lessons learned from companies sharing patient-level data and posting to the EudraCT database
  • Preparations for the public disclosure of transfers of value made to healthcare professionals and organizations
  • Guidelines to prepare and deliver patient lay summaries
  • Compliance with Good Publication Practice 3 (GPP3)
  • Communicating the results of trials to investigators and patients
  • Navigating varying posting requirements on ClinicalTrials.gov, EudraCT and other local registries
  • Avoiding open access fraudulent publishing
  • Discussing initial experiences with the posting requirement from NIH Final Rule of FDAAA
  • The redaction of clinical study reports (CSRs) for patient confidentiality
  • Analyzing the legal status of EMA Policy 0070

Previous Attendee Acclaim:

An excellent, highly interactive, targeted congress that attracts experts in their fields who willingly share their expertise.

Director, Scott Pharma Solutions Ltd.

The attendees represent a wide range of organizations, from the largest life sciences companies to organizations with very small trial portfolios, which makes for very interesting discussions.

COO, TrialScope

This conference was extremely helpful for me, as an academic cooperative group representative, to exchange views with and understand the work models and expectations of the industries with which we regularly partner for conducting cancer trials.

Associate Head, Statistics Department, Head, IDMC Unit, EORTC Headquarters

Good discussion and open exchange of experiences
related to public disclosure. Thanks!

Head, Medical Writing & Public Disclosure, Grunenthal GmbH

Interesting to mix publications and clinical trial disclosure audience — this should encourage us to work more
together in the future.

Anonymous

A great opportunity to share experiences with
your peers in the industry.

Disclosures Manager, F. Hoffmann-La Roche AG

This conference is very relevant and the output received will
be beneficial to the coming months/years working
with clinical trial disclosure.


IT Systems Manager, Novo Nordisk AS

It is a great platform for sharing of knowledge and
connecting people.

Associate Medical Writer, Novo Nordisk

Excellent to combine publications and disclosure
to find common touch points.


Global Publication Manager, LEO Pharma

Nice conference with high level of experts. I learned a lot
on the current and future improvements done by the
pharmaceutical industry/EFPIA/EMA/CT.gov for
disseminating clinical trial results accurately.

Senior Biostatistician, UCB

27-28 June 2017 Hotel Barceló Sants Barcelona, Spain