Planning for a Successful EMA Policy 0070 Submission
https://www.certara.com/article/planning-for-a-successful-ema-policy-0070-submission/
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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/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/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/EU-CTR Challenges Drug Developers Faced in the First 6 Months
Under European Union Clinical Trial Regulation 536/2014 (EU-CTR), replacing the EU Clinical Trial Directive (Directive 2001/20/EC), drug developers must now anonymize or redact clinical trial documents at the same time they are preparing them for regulatory submission (read more about the redaction process in this blog). This makes complying with transparency and disclosure requirements necessary … Continued
https://www.certara.com/blog/eu-ctr-challenges-drug-developers-face/FDA Seeking Feedback on Drug Approval Transparency and Disclosure Efforts
Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s (HC) Clinical Information … Continued
https://www.certara.com/blog/fda-seeking-feedback-on-drug-approval-transparency-and-disclosure-efforts/How AI Tech Is Changing Regulatory Writing
Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For example, the digital music service, Spotify, creates “mood-based” playlists that are curated to users’ musical preferences. Spotify generates these customized play lists using a machine learning algorithm that has learned your unique musical preferences based on your previous interactions with … Continued
https://www.certara.com/blog/how-ai-tech-is-changing-regulatory-writing/
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