Planning for a Successful EMA Policy 0070 Submission
https://www.certara.com/article/planning-for-a-successful-ema-policy-0070-submission/
15 results
Expert Answers to Your Questions on Developing EMA Policy 0070 Submissions
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 than for COVID-19 submissions), the process and new standards that go along with Policy 0070 will likely be new to many sponsors looking to authorize … Continued
https://www.certara.com/blog/expert-answers-to-your-questions-on-developing-ema-policy-0070-submissions/RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission
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 of being offline (other than for COVID-19 submissions), the process and new standards that go along with Policy 0070 will likely be new to many … Continued
https://www.certara.com/on-demand-webinar/raps-sponsored-webcast-how-to-plan-for-a-successful-ema-policy-0070-submission/Recap of EMA’s Policy 0070 Restart Webinar
On 16 May 2023, the European Medicines Agency (EMA) held a webinar to announce plans to restart the publication of clinical data contained in regulatory submissions under Policy 0070. The Policy was originally suspended in 2018 as part of EMA’s Business Continuity Plan for its relocation in the wake of Brexit (read about it in … Continued
https://www.certara.com/blog/recap-of-emas-policy-0070-restart-webinar/EMA Policy 0070 External Guidance Update
Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update – Major Changes Several major changes are noted in this … Continued
https://www.certara.com/blog/policy-0070-guidance-update/EMA Policy 0070 Compliance Tips from James Bond
In many ways, the strategic planning required to comply with EMA Policy 0070―a requirement to publish anonymized versions of clinical study reports (CSRs) and other submission documents―is similar to a secret agent’s mission: sponsors must keep the identities of people named or referred to in those documents top-secret while maintaining the document’s clinical utility. In … Continued
https://www.certara.com/blog/ema-policy-0070-compliance-tips-from-james-bond/Navigating EMA Policy 0070—How Do We Ensure Compliance?
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.
https://www.certara.com/on-demand-webinar/navigating-ema-policy-0070-how-do-we-ensure-compliance/Streamline Your Approach to EMA Policy 0070
Policy 0070― published by the European Medical Agency (EMA) in October 2014― has made the world of regulatory writing a more complicated place. The policy requires specified submission documents to be made public for all marketing authorization applications (MAA’s) submitted as of January 1, 2015 and for all indication extensions and line extensions submitted as … Continued
https://www.certara.com/blog/streamline-your-approach-to-ema-policy-0070/What’s the Difference between Anonymization and Redaction of Clinical Trial Data?
When it comes to disclosing data from clinical trials of investigational drugs to the public, the vernacular may seem just as confusing as the process! The terms “anonymization” and “redaction” are used interchangeably regarding transparency and disclosure of clinical trial data. But what are the differences in technique or method behind each? We may think … Continued
https://www.certara.com/blog/anonymization-redaction-clinical-trial-data/Choosing a Clinical Trial Transparency and Disclosure Vendor: Your Complete Checklist
Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D) requirements to health authorities is a critical decision. The vendor selection process varies greatly. Some organizations have rigorous prescribed procedures, while others boast a less formal, less structured process. You need to select a vendor who will help to maintain … Continued
https://www.certara.com/blog/checklist-clinical-trial-transparency-disclosure-vendors/