Navigating eCTD Submissions in China – Webinar скачать в хорошем качестве

Navigating eCTD Submissions in China – Webinar

Celegence - https://www.celegence.com/services/pu... - provides dossier submission services worldwide, supporting both eCTD and Non-eCTD electronic submissions [NeeS] formats. All submission services are supported by our experienced regulatory intelligence team, whose deep knowledge of local and regional guidelines ensure the provision of compliant and efficient regulatory publishing services. We can help streamline your end-to-end submissions management process, from dossier development to health authority interactions. With the rapid growth of the Chinese pharmaceutical market, more and more companies from overseas are launching their products in China, while the domestic companies in China continue to expand their product development globally. During interactions with health authorities, CTD and eCTD submissions are widely used all over the world to organize and submit regulatory dossiers in a globally harmonized format. China’s health authority, the National Medical Products Administration (NMPA) has also published drafts for Chinese eCTD requirements, technical specifications, and validation criteria to collect public feedback, which could be implemented in the near future. All eCTD submissions in China will be unique due to the usage of the local language and their specific regulatory requirements; these are challenges that sponsors planning to submit dossiers must be prepared for. This webinar will introduce the requirements for China eCTD submissions and how to develop strategies to comply with them. During our webinar titled “Navigating eCTD Submissions in China” James Ma, spoke specifically about his perspective on how to navigate eCTD submissions in China and the challenges that sponsors must be prepared for. Why should you watch this webinar? 1. To best understand the best practices relating to navigating eCTD submissions in China 2. To learn how the NMPA specific requirements may affect your current product lifecycle management 3. To examine the challenges in preparing for China eCTD submissions 4. To find out how to successfully accomplish a China eCTD submission If you’re curious how Celegence can help with your Publishing & eCTD needs, reach out to us at info@celegence.com!