Helen Ye

RA & PV Director at Accestra Consulting 

  • 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

Training format

Topic

  • Next: 16-17 Jun 2025 Live online
  • Also: 9-10 Oct 2025 Live online

Understanding Pharmacovigilance Regulations in APAC

Live online

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

  • 6 CPD hours Focused
  • Presented by Helen Ye
  • Next: 23 Jun 2025 Live online
  • Also: 23 Oct 2025 Live online

Navigating China’s API Regulations: An Essential Guide to DMF Registration

Live online

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.

  • 1.5 CPD hours High impact
  • Presented by Helen Ye