AMWA 2024 Medical Writing & Communication Conference
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.
자료
AI Enabled Regulatory Writing
- Brochure: From Protocol to Submission: Essential Regulatory Writing Resources
- Schedule a CoAuthor Demo: 규제 문서 작성을 위한 생명 과학에 특화된 생성형 AI
- Factsheet: CoAuthor
- Factsheet: eCTD Authoring Templates
Initial Clinical Trial Application:
- Factsheet: 규제 관련 컨설팅 및 허가 업무
- 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
- 사례 연구: Changing the Narrative on Narratives Using Technology-Enabled Authoring
- White Paper: Avoid & Fix Common Errors in Regulatory Submissions for Drug Products
Post Marketing
- Blog: 종합 안정성 보고의 위험 분류 및 관리
- 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
메디컬 라이팅
- Factsheet: Tailored Regulatory Writing