Navigating eCTD Submissions in China – Webinar with James Ma

What: Webinar – Navigating eCTD Submissions in China
When: Tuesday, September 14^th at 9 am (EST)
Where: Online Event
How: Register Here
Why: Join us for a webinar that will examine the requirements for China eCTD submissions and how to develop strategies for compliance.

With the rapid growth of the Chinese pharmaceutical market, more and more companies from overseas would like to launch their products in China while the domestic companies in China plan to globalize their product development. 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.

Join this featured presentation led by Regulatory & eCTD Solution Expert, James Ma, who will share his perspective on how to navigate eCTD submissions in China and the challenges that sponsors must be prepared for.

Celegence will be hosting this WEBINAR on Tuesday, September 14^th at 9 am EST. Register online now!

James Ma is responsible for the development and implementation of information technology strategies to enhance the company’s competitive edge. He leads technology platform design, cross-functional business solution building e.g., regulatory and eCTD solution, infrastructure set up, as well as information security enhancement.

James has over 20 years of IT experience in global pharmaceutical companies and CRO. His main focus was on application design and software engineering for large projects. He joined dMed from Pfizer China R&D Center, where he was the function lead of Information Management of Global Product Development Operations Center of Excellence.

This webinar will cover:

• An overview of China eCTD with relevant industry insights
• China eCTD submission specific requirements
• The challenges in preparing for China eCTD submissions
• How to successfully accomplish a China eCTD submission

Upon conclusion of the program, you will be able to:

• Understand the best practices relating to navigating eCTD submissions in China
• Learn how the NMPA specific requirements may affect your current product lifecycle management
• Hear James’ practical tips and guidance for navigation
• Examine examples and relevant case studies
• Have your most pressing questions answered during the Q/A session

This webinar is aimed towards companies in the life sciences industry, including middle and top level global regulatory professionals involved in:

• Regulatory Affairs
• Medical/Regulatory Labeling/Scientific Writing
• Regulatory Operations
• Electronic Regulatory Submissions
• Document and Project Management

Navigating eCTD Submissions in China webinar will be held on Tuesday, September 14^th at 9 am EST. Make sure you secure your spot at the webinar by registering now.

As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing, and health authority interactions. We leverage a global team of consultants to provide local regulatory insight, strategy, and intelligence. We are happy to share our insights with you during this webinar and hope that you can join us then.

Celegence provides subject matter experts, regulatory professionals, and eCTD publishing experts with relevant expertise to manage our end-to-end submission projects. Our team can manage all the necessary requirements of regulatory submissions including the management of the publishing technology partners, effectively enabling sponsors to focus on their core objectives. For more information, reach out to info@celegence.com or contact us online now.