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Event Overview

Seasoned professionals will align the most effective medical writing strategies for regulatory submissions, publication planning and research documentation and discuss effective ways to improve the quality of submissions. Learn effective communication strategies to build a successful medical writing team, an essential part of the success of any project. This Medical Writing conference will teach you the skills to create structured content while writing under extreme pressure.

This event will explore regulatory and publications from the top industry experts and discuss digital medical writing tools. Leverage your knowledge of publishing to demonstrate value and build customer loyalty. Take an in-depth look to improve medical writing methods to meet the deadline-driven environment and discover new insight into best practices.

Join the only Medical Writing conference that gives you the most exposure time in front of subject matter experts and top decision-makers who are looking for solutions to improve capabilities that support medical writing!

Event Sponsors
Conference
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Featured Speakers
Behtash Bahador
Associate Director, Relationship Management and Development
Center for Information and Study on Clinical Research Participation (CISCRP)
Christopher Michael
GCP Archivist
GSK
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Deepti Sanghavi
Sr Manager, Medical Writing
Virid Biosciences
Indira Subramanian
Associate Director, Publications Management, Medical Affairs
Regeneron Pharmaceuticals
Karen Young
Medical Writer
Lundbeck Pharmaceuticals
Kelley Hill
Executive Director, Global Medical Writing, Trial Transparency, and Disclosure
Alexion
Lingjie Guan
Regulatory Documentation Senior Scientist
Genentech
Lisa Brodeur
Technical Writing Team Lead
Baylis Medical Company
Oanh Stephan
Director, Global Submissions and Regulatory Documentation
BRISTOL MYERS SQUIBB
Sheetal Patel
Medical Director, US Medical Affairs
Lundbeck Pharmaceuticals
Soheil Chavoshi
Executive Director, Scientific Communications & Medical Information
Acadia Pharmaceuticals
Stephen W. Gutkin
Senior Director, Scientific Publication Writing
Ascentage Pharma
Sulochana Gawande
Executive Director, Medical Writing
Karyopharm Therapeutics
Sylvia Baedorf Kassis
Program Manager
Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Tatyana Wanderer
Senior Director and Head of Medical Writing
SYROS PHARMACEUTICALS
Vishal Soni
Executive, Regulatory and Scientific MW
Virid Biosciences
Yue Liu
Associate Director, Oncology Publications, Global Scientific and Medical Publications
Merck & Co., Inc.
Event Schedule
  • Introduce/refresh attendees on the multiple complex guidances and regulations governing clinical trial transparency
  • Identify key points in the life cycle of a study/clinical program where transparency requirements apply
  • Building capabilities for transparency within your organization
  • Learn how to stand out amongst every applicant
  • Prioritize the best tools that all medical writers should know when looking for their next job
  • How to let others know your services meet their needs 
  • Appreciate the importance of fair balance, which will identify you as a more ethical researcher and your writing as more acceptable to journals
  • Take a case study approach, understand potential defects in study design and a failure to consider alternative conclusions from reported data
  • Participate in interactive exercises to detect “unfair imbalance” more effectively, including two major sources of error: statistical and human
  • Address real challenges while collaborating with your team
  • Rebuild teamwork methodologies around working remotely
  • Instill strategies for updating, marking up and commenting in parallel with your team
  • Receive stakeholders' input and approvals while maintaining the project schedule
  • Discuss the gap in the standard practice of aligning the publication plan with regulatory filings
  • Analyze critical precautions to confirm the validity of the presented data
  • New regulations that affect the publications process- EU policy 70, clinicaltrials.gov disclosures, lay summaries
  • Find out the key difference in regulatory and publications documents
  • Updates and guidelines COPE, GPP3, ICMJE, and Equator
  • When lines get blurry - how to approach difficult situations with integrity
  • Overcome the skepticism of AI integrations in medical writing
  • Grasp practical applications and look ahead to future development
  • Assess hybrid approaches for structuring documentation
  • Discuss updates and guidelines COPE, GPP3, ICMJE and Equator
  • Avoid falsification of data, misappropriation of the ideas of others and improper assignment of credit to ensure ethical standards are met
  • Prevent plagiarism and self-plagiarism in your publications
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Event Partners
15
Speakers
21
Days
251
Participants
125
Workshops
90
Venue
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