Navigating China’s API Regulations: An Essential Guide to DMF Registration Training Course
Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.
As China becomes an increasingly important market for pharmaceutical companies, compliance and safety are crucial.
This webinar has been designed to provide participants with a better understanding of the latest developments in China's Active Pharmaceutical Ingredients (APIs) regulations, including the new Drug Master File (DMF) registration routes that protect the confidentiality and interest of active drug substance suppliers.
Join our panel of industry experts as they discuss API registration in China and the quickest pathway options for DMF registration. Gain valuable insights into the related requirements and stay up-to-date with the dynamic and fast-changing regulations in China.
Don't miss this opportunity to enhance your knowledge of DMF, API, and China and learn from our industry leaders from this important region.
Gain in-depth knowledge and insights on how to register your Active Pharmaceutical Ingredient (API) in China
Stay up-to-date on the latest API and DMF regulations and requirements for China
Enhance your regulatory knowledge and skills for China and learn about the local requirements for Active Pharmaceutical Ingredient (API) registration
Ensure compliance and safety by staying informed of the latest regulatory developments in China's API registration process
Engage with industry experts and get your questions answered in real-time
Gain competitive advantage by understanding the complexities of API registration in China and the quickest and most effective pathways for registration
Who Should Attend?
This webinar is designed for professionals who are involved in the pharmaceutical industry and need to understand the latest regulations on how to register APIs successfully in China. Targeted audience includes:
Regulatory Affairs professionals who need to stay up-to-date with the latest regulatory developments in China's API registration process
CMC Managers who need to ensure compliance and safety in the API registration process in China
Quality Assurance Managers who need to understand the local requirements for API registration in China
Project Management Professionals who are involved in the API registration process in China and need to ensure timely execution of the registration process
Business Planning Professionals who need to understand the complexities of API registration in China for successful business planning
Commercial Management Professionals who need to stay informed of the latest regulatory developments in China's API registration process for effective business management
Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China.
She is experienced in regulatory compliance of China market access & post-marketing maintenance of pharmaceutical products, providing insightful and customised solutions to international pharmaceutical companies and government institutions.
She leads the registration team to plan, develop and implement compliance strategies for top pharma clients and has a successful track record for obtaining market approval for drug products, APIs, Excipients, Packaging Materials, medical devices and other products.
Ms. Ye has a strong communication network with Chinese authorities (e.g. NMPA and CDE) and industry experts in China.
To learn more about Helen or Accestra Consulting, please visit their website at www.accestra.com
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