Conference 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