增强药物开发的确定性

Sponsor companies are now expected to submit globally as quickly as possible.&nbsp; Successful achievement of this combination of speed and complexity requires extensive regulatory knowledge and planning.&nbsp; The first half of this webcast will cover how to plan for simultaneous global submissions, including aspects the team can control and aspects that are out of the &hellip; <a href="https://www.certara.com.cn/webinar/sponsored-webcast-best-practices-for-simultaneous-submissions-to-ema-fda/">Continued</a>

随着 GPTs 的出现，法规撰写者面临着机遇和挑战。机会在哪里？自动化并加快他们总结文本和研究数据源的速度。挑战是什么？抓住这一机遇的关键之一是精心编写、合理使用和在团队内部共享提示：&hellip; <a href="https://www.certara.com.cn/webinar/summarize-this-gpt-prompts-for-regulatory-writers/">Continued</a>

eCTD v4.0 正在加速推出。全行业转型的时机不再是遥远的未来，而是现在。一个卫生局已经上线，一个将在今年(2024年)上线，还有多个卫生局计划在明年内实施。Certara has hosted webinars on eCTD v4.0, held GlobalSubmit user &hellip; <a href="https://www.certara.com.cn/webinar/answers-to-the-top-ectd-v4-0-questions-in-2024/">Continued</a>

The Inflation Reduction Act (IRA), one of the key legislative achievements the Biden-Harris administration, aims to expand benefits and reduce costs for Medicare beneficiaries. Among its provisions, the IRA introduced a significant temporary reimbursement boost for biosimilar drugs under Medicare Part B, designed to encourage their adoption.   Biosimilars, often referred to as follow-on biologics, are … Continued

When it comes to efficient clinical study build, content is king. Most importantly: metadata content. Metadata is the building blocks of your study. It’s the forms, terminologies and datasets you need to structure your study and start collecting data.  Managing clinical trial metadata can be challenging. You have to find the right content, make sure … Continued

aCRFs are a mandatory requirement of the FDA, and therefore a key submission deliverable for any clinical trial. Creating quality annotated case report forms (aCRFs) takes time and attention to detail.   So, it’s important to understand what regulatory and industry guidelines are out there, to ensure your aCRFs meet the requirements.  What are annotated CRFs?  … Continued