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The APAC region is home to countries with large patient populations with urgent unmet medical needs. To speed up the approval process for drugs from foreign multinational companies to address urgent unmet medical needs, APAC countries such as China have introduced fast-track review and approval programs through the Drug Administration Law. However, to take advantage of these new fast-track review and approval programs, multinational companies must submit CTDs in Simplified Mandarin Chinese to the NMPA. With fast turnaround times, highly technical and accurate language, and large project scales, CTD submissions in APAC markets are complex. Language service providers have the scalability to not only handle the massive scale and quick turnaround time, but also to help pharmaceutical companies with project planning for successful CTD submissions in APAC markets.

Leveraging CSOFT advisor Dr. Victoria Elegant's extensive background in regulatory compliance and approvals for the APAC region, this workshop from CSOFT’s Di Lv and Diego Di Leva will discuss how language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China, as well as best practices for CTD project management to ensure precision and regulatory compliance.