Event Sponsors
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
This is a short bio section
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
- Establishing a clear line of communication
- Set manageable expectations with your team
- Emphasize concise writing
- Effectively cater to your audience
- Prepare for both simple and detailed documentation
- 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
- Design your research to answer questions that are directed to your audience
- Clearly articulate your message for patients
- Implement constant awareness of the reader
- 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
November 13, 2020
9:00 AM - 10:00 AM
Build an Effective Working Culture with your Medical Writing Team
- 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
Speakers:
Lingjie GuanRegulatory Documentation Senior ScientistGenentech- Lisa BrodeurTechnical Writing Team LeadBaylis Medical Company
- Kelley HillExecutive Director, Global Medical Writing, Trial Transparency, and DisclosureAlexion
- Oanh StephanDirector, Global Submissions and Regulatory DocumentationBRISTOL MYERS SQUIBB
- 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
- Learn how to enhance your content and execute formatting
- Apply proper systems when handling delayed timelines
- Internalize communication techniques that will guide you through working remotely
