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Global Regulatory Updates • Data Sharing Expectations • Results Posting Requirements

June 12-13, 2018
  • Lisbon, Portugal

With new and evolving developments on the regulatory front, 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, convening with industry experts is more crucial than ever. CBI’s Publication
and Clinical Trial Transparency Congress
serves as the only life sciences
forum uniting publication planning,clinical trial transparency, disclosure and
data sharing professionals to benchmark plans for coordinating results
postings in registries and journals and share strategies for complying
with transparency and global regulations.

Benefit from Expert Insights On:

  • Updates on ICMJE patient data sharing
  • Experiences and lessons learned from companies sharing patient-level data and posting to the EudraCT database
  • Guidelines to prepare and deliver patient lay summaries
  • Analyze the FDAAA Final Rule implementation
  • Discuss redaction standards of clinical study reports (CSRs) for patient confidentiality
  • Where do we stand with Policy 0070?
  • Benchmark with peers on industry data anonymisation practices
  • Prepare publication strategy with transparency requirements in mind

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

Global Regulatory Updates • Data Sharing Expectations • Results Posting Requirements

With new and evolving developments on the regulatory front, 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, convening with industry experts is more crucial than ever. CBI’s Publication
and Clinical Trial Transparency Congress
serves as the only life sciences
forum uniting publication planning,clinical trial transparency, disclosure and
data sharing professionals to benchmark plans for coordinating results
postings in registries and journals and share strategies for complying
with transparency and global regulations.

Benefit from Expert Insights On:

  • Updates on ICMJE patient data sharing
  • Experiences and lessons learned from companies sharing patient-level data and posting to the EudraCT database
  • Guidelines to prepare and deliver patient lay summaries
  • Analyze the FDAAA Final Rule implementation
  • Discuss redaction standards of clinical study reports (CSRs) for patient confidentiality
  • Where do we stand with Policy 0070?
  • Benchmark with peers on industry data anonymisation practices
  • Prepare publication strategy with transparency requirements in mind

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