Press Release (ePRNews.com) - TORONTO - Nov 19, 2018 - Join regulatory affairs expert Peiling Shih, Executive Director of Regulatory Strategic Development, APAC, at Clinipace for a live webinar on Monday, Dec. 3, 2018, at 12 p.m. EST (5 p.m. GMT).
Historically, the review and approval of a Chinese investigational new drug (IND) has taken a year or even longer to complete, and new drug application (NDA) approval for a new drug lagged behind Western countries by four or five years. Recently, the National Medical Products Administration announced changes to encourage pre-IND consultation and shortened the clinical trial approval process to 60 working days, opening up new opportunities to expedite development. Changes were also made to encourage NDA submissions that are aligned with submissions in other regions.
Viewers will learn how to plan first IND applications in China. The presenter will:
- Provide a detailed review of the new 60-day review system
- Explain new ways to consult with Chinese regulatory authorities
- Additionally, this talk will also:
- Cover China’s current thinking about accepting foreign data for the approval of new drugs
- Explain how to apply ICH E5 and ICH E17 to facilitate simultaneous registration of medicinal products in different geographic regions
A Q&A session with the audience will be included at the end of the presentation. For more information about this complimentary webinar, visit Recent Changes to Drug Approvals in China: Regulatory Consultation, IND Submission and Acceptance of Foreign Data in NDA.
At Clinipace, a global, full-service contract research organization (CRO), our approach to clinical research is personal. We deliver a level of collaboration and flexibility not possible in a traditional CRO environment. Our personalized services and solutions, local regulatory expertise and therapeutic leadership are designed to face the most difficult industry challenges across all major therapeutic areas including oncology, gastroenterology, nephrology and urology. We strive to improve the way clinical research is performed and impact the future of health care using the most advanced technology and a CHALLENGE ACCEPTED approach.
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