FAQs on Developing EMA Policy 0070 Submissions
This blog answers audience questions posed during our RAPS webinar, How to Plan for a…
Certara2025 年 9 月 15 日
Best Practices for Safety Narrative Writing in Clinical Research
Explore the patient narrative format in medical writing and why narrative writing in clinical research…
Certara2025 年 9 月 5 日
Regulatory Operations Best Practices for Health Canada Submissions
Health Canada submissions now require eCTD/CESG; regulatory operations expert support can streamline the process and…
Certara2025 年 8 月 11 日
Everything you need to know about ILAP 2.0
This white paper share’s key insights on the relaunch of MHRA’s Innovative Licensing and Access…
Certara2025 年 5 月 19 日
Protect Confidential Information in Investigational Drug Submissions
2025 年 3 月 20 日 Health regulatory agencies require pharmaceutical companies to protect study participants’ personal information…
Certara2025 年 3 月 20 日
Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study
The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…
Certara2025 年 3 月 20 日
EU CTIS: Europe’s New Clinical Trial Information System
The EU CTIS is now fully implemented, replacing EudraCT as the central hub for clinical…
Certara2025 年 2 月 10 日
Anonymization vs. Redaction of Clinical Trial Data
2025 年 1 月 17 日 The vernacular for disclosing pharmaceutical clinical trial results to the public may…
Certara2025 年 1 月 17 日
Helping Sponsor Meet EMA Policy 0070 Requirements
The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for…
Certara2025 年 1 月 7 日
Streamlining the Preparation of 1-Year and 2-Year PSURs
We explore how we helped one client deliver a last-minute addition to a Periodic Safety…
Certara2024 年 12 月 18 日
