イベント・学会参加情報
日にち
October 23 - 26, 2024
Location
New Orleans, LA
AMWA 2024 Medical Writing & Communication Conference
Hear insights from Certara experts during these sessions:
Oct 24, 2024 | 9:30 am – 11:00 am
Planning and Preparing Regulatory Submissions Anchored by Target Product Profile (TPP) and Prescribing Information (PI)
Brenda Taylor | Director, Global Submissions | サターラ
Mark Bowlby | Senior Director, Global Submissions | サターラ
2024年10月25日 | 3:00 pm – 4:00 pm
Navigating the Ever-changing Technology Landscape: Evaluation, Implementation, and Change Management
Heather Graham | Vice President, Regulatory Science and Medical Affairs | サターラ
Angela Winnier | Senior Director, Medical Writing | Pfizer
Matthew Renda | Senior Director, Medical Writing Operations | Alexion Pharmaceuticals
2024年10月26日 | 8:00 am – 9:45 am
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.
コンテンツ
AI Enabled Regulatory Writing
- パンフレット：From Protocol to Submission: Essential Regulatory Writing Resources
- Schedule a CoAuthor Demo: 薬事規制文書のための生成AIとライティングソフトウェア
- Factsheet: CoAuthor
- Factsheet: eCTDオーサリングテンプレート
Initial Clinical Trial Application:
- Factsheet: 規制対応と薬事申請コンサルティング
- Blog: 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
- 事例：テクノロジーを駆使したオーサリングで患者ナラティブに変革をもたらす
- White Paper: Avoid & Fix Common Errors in Regulatory Submissions for Drug Products
Post Marketing
- Blog: Categorizing & Managing Risks in Aggregate Safety Reports
- White Paper: DSURs, RMPs, and PSURs – The Harmonization of Pharmacovigilance Documents
- On-demand webinar: RAPS Sponsored Webcast: Author Clinical Study Reports with Data Privacy & Disclosure in Mind
- Blog: Expert Answers to Your Questions on Developing EMA Policy 0070 Submissions
メディカルライティング
- Factsheet: Tailored Regulatory Writing
