Streamline Clinical Data Publication Under EMA Policy 0070 Blog Post
Anaya Rehman Evan Richardson February 14, 2025 The European Medicines Agency (EMA) Policy 0070 requires clinical data publication. Its mandate is to build public trust and enhance transparency in pharmaceutical...
Helping Sponsor Meet EMA Policy 0070 Requirements Blog Post
The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for Human Use, commonly known as EMA’s Policy 0070, requires drug companies to proactively share the...
FAQs on Developing EMA Policy 0070 Submissions Blog Post
In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish all clinical studies submitted for regulatory approval. After almost five years of being offline (other…
Pharma Focus Europe – Issue 03 – Using AI to Accelerate Drug Development Blog Post
Authors: Professor Amin Rostami-Hodjegan, Professor Piet van der Graaf This Pharma Focus EU article, co-authored by Amin Rostami-Hodjegan, SVP of Research & Development and CSO at Certara, and Professor Piet…
RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission Blog Post
In September 2023, the European Medicines Agency (EMA) will reinstate their Policy 0070 requirement to publish all clinical studies submitted to the EMA for regulatory approval. After almost five years…
Navigating EMA Policy 0070—How Do We Ensure Compliance? Blog Post
Speaker Lora Killian provides insight on how EMA Policy 0070 will affect your organization and how to facilitate compliance, addressing many critical transparency and disclosure issues.
MIDD can ease pediatric & rare disease drug loss in Japan Blog Post
Certara tackles pediatric cancer and rare disease drug loss in Japan by advocating MIDD, which can help optimize clinical trials and support data integration and analysis.
