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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/

European & Canadian Partnership Streamlines Clinical Data Anonymization & Redaction

Over seven years ago, the Management Board of the European Medicines Agency (EMA) adopted Policy 0070, a requirement to publish anonymized versions of clinical study reports (CSRs) and other regulatory submission documents. In December 2018, EMA enacted their business continuity plan, which meant publication of clinical data was put on hold. A limited return of … Continued

https://www.certara.com/blog/european-canadian-partnership-streamlines-clinical-data-anonymization-redaction/

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/

Brexit Impact on EudraCT Postings

The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no … Continued

https://www.certara.com/blog/brexit-impact-on-eudract/

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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