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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand recording from November 2022.
The Clinical Trials Regulation (CTR) for the European Union (EU) took effect on January 31, 2022. Sites and sponsors must now embrace the new regulations to successfully run clinical trials across the European Union.
Beginning on January 31st, 2023, sponsors are required to use the Clinical Trials Information System (CTIS) for all new clinical trial submissions in the EU. All active trials need to be transferred to CTIS by January 31st, 2025. This three-year transition period will require drug developers to undergo an incredible amount of change.
In addition, under EU-CTR, drug developers must now anonymize or redact clinical trial documents at the same time they are preparing them for regulatory submission. This makes complying with transparency and disclosure requirements necessary now, not later during the product approval stage.
Lastly, EU-CTR requires a Plain Language Summary (PLS) or “Lay” Summary for every clinical trial conducted in Europe. A PLS explains the trial and its results, and it’s written at a 4th-8th grade reading level, without scientific jargon. This new PLS requirement is designed to better inform patients volunteering in clinical trials, thus making the drug development process more inclusive and transparent.
In this webinar, Certara experts Gabriella Mangino and Anaya Rehman will talk through the changes and lessons learned nearly 6 months after CTIS was implemented. They’ll share first impressions, talk through some of the biggest challenges to date and share what next steps sponsors should take to continue to prepare for the challenges that still lie ahead.
Regulatory Affairs Professionals
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