AMWA 2024 Medical Writing & Communication Conference
即将召开的会议
Hear insights from Certara experts during these sessions:
Planning and Preparing Regulatory Submissions Anchored by Target Product Profile (TPP) and Prescribing Information (PI)
Brenda Taylor | Director, Global Submissions | Certara
Mark Bowlby | Senior Director, Global Submissions | Certara
Navigating the Ever-changing Technology Landscape: Evaluation, Implementation, and Change Management
Heather Graham | Vice President, Regulatory Science and Medical Affairs | Certara
Angela Winnier | Senior Director, Medical Writing | Pfizer
Matthew Renda | Senior Director, Medical Writing Operations | Alexion Pharmaceuticals
Roundtables with breakfast
- Writing an Initial Investigator’s Brochure for a First in Human Trial | Brenda Taylor
- I Can Complete That Submission in X Weeks! | Steve Sibley
- Accelerate Your Patch to Becoming a Medical Writer: Become a PM | Demetrius Carter
See our regulatory solutions in action!
Our experts will demo CoAuthor, our GenAI-enabled writing platform.
资源
AI Enabled Regulatory Writing
- Brochure: From Protocol to Submission: Essential Regulatory Writing Resources
- Schedule a CoAuthor Demo: 针对法规撰写的生命科学专业通用人工智能
- Factsheet: CoAuthor™
- Factsheet: eCTD 创作模板
Initial Clinical Trial Application:
- Factsheet: 申报审批咨询及相关事务
- 博客：Authoring & Assembling IND & CTA Applications – Insights & Updates
- White Paper: New EU Clinical Trial Regulation
Mid-Stage Development
- Publication: Clinical Study Protocols: How to Write to Solve Problems Now and Avoid Big Ones in the Future
- 案例研究：使用技术辅助创作功能，改变有关叙事的叙述
- White Paper: Avoid & Fix Common Errors in Regulatory Submissions for Drug Products
Post Marketing
- 博客：在汇总安全报告中分类和管理风险
- White Paper: DSUR、RMP 和 PSUR — 统一药物警戒文件
- On-demand webinar: RAPS Sponsored Webcast: Author Clinical Study Reports with Data Privacy & Disclosure in Mind
- 博客：专家回答您关于制定 EMA 政策的问题 0070 投稿
医学撰写
- Factsheet: Tailored Regulatory Writing
