11th EMWA Symposium

Clinical Trial Disclosure and Transparency: Impact on Medical Writing and Communication (Clinical Trial Regulation EU 536/2014)
Thursday 11 May 2023

Expert speakers representing different stakeholders will share their views and insights on the EU CTR, with focus on new requirements and processes and their impact on functions in medical writing and communications. We will be hearing different perspectives from representatives of:

• European Medicines Agency (EMA) outlining the reasons behind the changes in the new CTR and the Agency’s approach
• European Federation of Pharmaceutical Industries and Associations (EPFIA), providing the insights on the industry’s early experiences
• Pharmaceutical companies as clinical trial sponsors, describing considerations and strategies in planning, authoring, and redacting study documents 
• Regulatory medical writers and pharmacovigilance writers highlighting the main impacts on medical writers from a documentary perspective
• Transparency specialists
• Contract research organisations and medical writing agencies
• Patient advocacy groups explaining why the changes in the CTR are important for them
• Publications professionals sharing their experiences and views on how EU CTR and its disclosure and transparency  requirements regulation are is influencing scientific publications from the perspective of the pharmaceutical industry and publishers perspectives

The symposium will have a well-paced mix of presentations and panel discussions, with free-flowing dialogue between speakers and panellists as well as ample opportunities for delegates to raise questions.

There is the option to join the Symposium online.

• 9:00 AM
  to
  9:20 AM
  

  Introduction and welcome
  Kathy Thomas-Urban Raquel Billiones


• 9:20 AM
  to
  10:00 AM
  

  EMA Transparency journey and impact on its stakeholders
  Morgane De Verdiere


• 10:00 AM
  to
  10:40 AM
  

  EFPIA perspective Regulation EU 536/2014/CTIS – and its implications on new requirements – particularly those requirements that affect the publicly disclosed documents.
  Polyana Bastos Silvia Garcia


• 10:40 AM
  to
  11:00 AM
  

  Refreshment break
  


• 11:00 AM
  to
  11:50 AM
  

  Clinical Trial Start Up – Sponsor perspective
  Merete Jorgensen Paula Nixon


• 11:50 AM
  to
  12:25 PM
  

  Clinical Trials Conduct: Industry perspective - Documents impacted during study conduct
  Sarah Bly


• 12:25 PM
  to
  1:30 PM
  

  Lunch and exhibition viewing and poster presentations
  


• 1:30 PM
  to
  1:35 PM
  

  Summary of the morning session
  Lisa Chamberlain James


• 1:35 PM
  to
  2:00 PM
  

  Clinical Trials Conduct: PV perspective - EU Clinical Trials Regulation and publication of Risk Management Plans – impact on DSURs and RMPs
  Sven Schirp


• 2:00 PM
  to
  3:20 PM
  

  Clinical Trials Results Reporting and Dissemination
  Patient/patient groups perspective Lisa Chamberlain James, Jan Geissler - Impact of EU CTR on scientific peer-reviewed publications John Gonzalez, Priti Nagda


• 3:20 PM
  to
  3:40 PM
  

  Refreshment break
  


• 3:40 PM
  to
  4:50 PM
  

  Panel Session: Ask the experts
  


• 4:50 PM
  to
  5:00 PM
  

  Summary and conclusions
  


• 5:00 PM
  to
  5:00 PM
  

  End of Symposium
  

Symposium Media Partner:

The Publication Plan is a free central online resource delivering up-to-date news on key issues for everyone in the medical publications industry. Every week, we curate and deliver the latest industry updates via our website, email alerts, Facebook, Twitter and LinkedIn. Our dedicated global readership already includes medical writers, publication planners, researchers, pharmaceutical industry members, medical journal editors and publishers.