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The Westin Boston Seaport District

10 mar 2025 8:00 a.m. - 12 mar 2025 12:30 p.m.

425 Summer Street, Boston, MA 02210, USA

Medical Affairs and Scientific Communications Forum

The longest running neutral forum cultivating interdepartmental relationships in medical affairs.

Early Bird Rates Expire

DAYS

HOURS

MINUTES

SECONDS

Session 3 Track 2: Writing for Regulatory Agencies: Leadership in Collaborative Authoring & Interpreting Clinical Study Results

Session Chair(s)

Elizabeth  Brown, MS, PMP

Elizabeth Brown, MS, PMP

Executive Director, Medical Writing & Disclosure

Merck & Co., Inc., United States

This session explores the complexities involved in writing clinical research results for regulatory submissions, emphasizing the importance of both effective collaborative authoring and accurate interpretation of efficacy data. First, we will provide insights into the leadership role that medical writers must assume in collaborative authoring environments, where tools like SharePoint and Veeva are utilized for document development across functions. Attendees will learn about common pitfalls and strategies for maintaining document quality through effective leadership and communication. Then, we will delve into navigating efficacy data interpretation under the ICH E9 (R1) framework, highlighting how the treatment policy estimand can lead to confounding results. By examining case studies, participants will gain a clearer understanding of how to assess various estimands and their implications for clinical trial outcomes. Overall, this session aims to equip medical writers with practical skills to improve document quality and efficacy data analysis critical for regulatory submissions.

Learning Objective :
  • Address pitfalls in collaborative authoring and propose workflow strategies
  • Highlight leadership qualities for timely, high-quality deliverables
  • Discuss ICH E9 (R1) estimands and impact of confounding
  • Assess non-efficacy data interpretation
  • Improve reporting for regulatory submissions

Speaker(s)

Rebecca R Pogue, PhD

What happened? How to interpret efficacy data when significance varies by estimand

Rebecca R Pogue, PhD

Syner-G Biopharma Group, United States

Manager of Medical Writing and Submission Management

Meagan  Eldridge, MS

Medical Writing Process Leadership for Effective Collaborative Authoring

Meagan Eldridge, MS

Eldridge Writing & Consulting LLC, United States

President

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