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Wednesday, June 21 • 4:00pm - 5:15pm
#367: Writing of Layperson Summaries of Clinical Trial Results According to the EU: Regulation and Its Impact on Global Pharmaceutical Activities

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

For the first time there is regulation in a key geographical area that mandates that trial results are presented in a lay friendly way. This session will discuss how this is a unique opportunity to redefine the relationship between sponsors, investigators, study participants, and patient organizations. Although limited to the EU, most sponsors will make lay summaries available globally.

Learning Objectives

Describe the challenges of actual writing of lay summaries and the implementation of a process for individual sponsors.

Chair

Susannah Chang, PhD

Speaker

Plain Language Summaries: Large Scale Writing and Process Implementation
Tatyana Wanderer, PhD

Layperson Summaries: Gathering Patient Insights and Evolving Processes
Amber Barnes, PhD, RAC

Meeting the EU Mandate for Plain Language Trial Results Summaries: Successes, Challenges and Key Considerations
Behtash Bahador

Meaningful Information Exchange with Trial Participants: Update From the TransCelerate Information Exchange Team
Julie Dietrich, MS



Speakers
avatar for Behtash Bahador

Behtash Bahador

Senior Manager, Quality and Compliance, CISCRP
Behtash Bahador is a Senior Manager at the non-profit CISCRP. With a background in health communication, Behtash leads quality and compliance assurance on CISCRP’s program that provides non-promotional and unbiased trial results summaries in an easy-to-understand format for pat... Read More →
avatar for Amber Barnes

Amber Barnes

Director, Global Medical Writing, UCB Biosciences, Inc.
Amber manages a team of highly skilled medical writers who contribute to the clinical development of innovative medicines by delivering high quality, scientifically sound submission related documents. Amber holds a PhD in Molecular Medicine from Wake Forest University and a B.S i... Read More →
avatar for Susannah Chang

Susannah Chang

Manager, Oncology Regulatory Medical Writing, Janssen Pharmaceutical Companies of Johnson & Johnson
Susannah is a member of the TransCelerate subteam on Layperson Summaries and has been developing a layperson template for use at Janssen. She received her PhD in neurobiology from UC San Diego, completed postdoctoral research in Germany, and was a research assistant professor at... Read More →
avatar for Julie Dietrich

Julie Dietrich

Director, Clinical Development, Amgen Inc.
Julie Dietrich is a Director in Amgen’s Development Design Center (DDC). The DDC is a group of drug development experts that partner with product teams to design and plan optimized clinical programs and innovative solutions. Julie also is leading company-wide initiatives relate... Read More →
avatar for Tatyana Wanderer

Tatyana Wanderer

Director, Strategic Partnership Alliances, Synchrogenix, a Certara Company
During her 10-year career as a clinical regulatory writer, Dr. Wanderer has authored and coordinated high quality production of a variety of ICH-compliant regulatory documents in the US and Asia. She leverages her leadership and project management skills, advising clients and man... Read More →


Wednesday June 21, 2017 4:00pm - 5:15pm
S502ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616